Objectives: First, to determine the resources and costs required to implement an early rehabilitation (ABCDEF) bundle. Second, to compare the impact of the bundle on costs pre- and post-implementation.
Design and setting: Cost analysis was conducted as part of an implementation study at McMaster Children's Hospital PICU in 2018-2020.
Measurements and main results: Resource estimates for all implementation activities from 2018 to 2020 were calculated from material costs and hours spent by personnel multiplied by wages. PICU and patient-level costs before (from January 2019 to March 2019) and after bundle implementation (from January 2020 to March 2020) were compared using case-costing data. Linear regression was used to analyze log-transformed costs adjusted for age, sex, and severity of illness score. Costs are reported in Canadian dollars (CAD). A total of 907 hours were spent over a 2-year implementation period, at an estimated cost of CAD 50,813. Physicians contributed the most hours, followed by the nurse educator and pharmacist. Material costs were CAD 860. There were 141 patients pre-implementation and 84 patients post-implementation in the analyses. Adjusted mean PICU cost per patient was CAD 17,342 and CAD 20,310, pre- to post-implementation, respectively; mean difference (95% CI) between post- and pre-implementation was 17% higher (95% CI, from 6.3% lower to 46% higher). Adjusted mean pharmacy cost per patient was CAD 834 pre-implementation and CAD 827 post-implementation; mean difference of 0.8% lower post-implementation (95% CI, from 27% lower to 35% higher).
Conclusions: Implementation of the ABCDEF bundle requires significant time and collaboration of key stakeholders. There was no impact on PICU or patient costs following bundle implementation, but the period of observation was limited by COVID-19. Future studies should include cost analyses that incorporate longer-term, patient-centered health outcomes to determine whether this intervention is cost-effective.
{"title":"Early Rehabilitation Bundle in a Canadian PICU: Cost Analysis of Implementation in 2018-2020.","authors":"Shira Gertsman, Sureka Pavalagantharajah, Lindsey Falk, Sayem Borhan, Kevin Kennedy, Lehana Thabane, Feng Xie, Cynthia Cupido, Karen Choong","doi":"10.1097/PCC.0000000000003806","DOIUrl":"10.1097/PCC.0000000000003806","url":null,"abstract":"<p><strong>Objectives: </strong>First, to determine the resources and costs required to implement an early rehabilitation (ABCDEF) bundle. Second, to compare the impact of the bundle on costs pre- and post-implementation.</p><p><strong>Design and setting: </strong>Cost analysis was conducted as part of an implementation study at McMaster Children's Hospital PICU in 2018-2020.</p><p><strong>Measurements and main results: </strong>Resource estimates for all implementation activities from 2018 to 2020 were calculated from material costs and hours spent by personnel multiplied by wages. PICU and patient-level costs before (from January 2019 to March 2019) and after bundle implementation (from January 2020 to March 2020) were compared using case-costing data. Linear regression was used to analyze log-transformed costs adjusted for age, sex, and severity of illness score. Costs are reported in Canadian dollars (CAD). A total of 907 hours were spent over a 2-year implementation period, at an estimated cost of CAD 50,813. Physicians contributed the most hours, followed by the nurse educator and pharmacist. Material costs were CAD 860. There were 141 patients pre-implementation and 84 patients post-implementation in the analyses. Adjusted mean PICU cost per patient was CAD 17,342 and CAD 20,310, pre- to post-implementation, respectively; mean difference (95% CI) between post- and pre-implementation was 17% higher (95% CI, from 6.3% lower to 46% higher). Adjusted mean pharmacy cost per patient was CAD 834 pre-implementation and CAD 827 post-implementation; mean difference of 0.8% lower post-implementation (95% CI, from 27% lower to 35% higher).</p><p><strong>Conclusions: </strong>Implementation of the ABCDEF bundle requires significant time and collaboration of key stakeholders. There was no impact on PICU or patient costs following bundle implementation, but the period of observation was limited by COVID-19. Future studies should include cost analyses that incorporate longer-term, patient-centered health outcomes to determine whether this intervention is cost-effective.</p>","PeriodicalId":19760,"journal":{"name":"Pediatric Critical Care Medicine","volume":" ","pages":"e1198-e1207"},"PeriodicalIF":4.5,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144795020","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-10-01Epub Date: 2025-08-14DOI: 10.1097/PCC.0000000000003813
Isabel Johnson, Katy Bridges, Richard Cleaver, Rayka Malek, Mary Cross, Steve Cunningham, Katrina Cathie, Mark D Lyttle, Rebecca Mitting, Paul Mouncey, Damian Roland, Stephen Turner, Olu Onyimadu, Stavros Petrou, Debra Quantrill, Kate Chadwick, Leila Janani, Padmanabhan Ramnarayan
Objectives: The Breathing Assistance in Children with bronchiolitis (BACHb) trial aims to evaluate the clinical and cost-effectiveness of high-flow nasal cannula (HFNC) therapy compared with humidified standard oxygen (HSO) in infants with moderate bronchiolitis, and HFNC with continuous positive airway pressure (CPAP) in severe bronchiolitis.
Setting: Fifty hospitals across England, Scotland, and Wales.
Patients: Hospitalized infants younger than 12 months old with a clinical diagnosis of bronchiolitis, assessed at least twice 15 minutes apart to fulfill criteria for either severe bronchiolitis (one or more of: respiratory rate > 70 breaths/min, grunting, marked chest recession, recurrent short apneas) or moderate bronchiolitis (lack of response to low-flow oxygen, indicated by persistent hypoxemia and/or moderate respiratory distress).
Interventions: "Moderate bronchiolitis stratum": HFNC at a flow rate of 2 L/kg/min vs. HSO through a facemask or headbox at a flow rate up to 15 L/min. "Severe bronchiolitis stratum": HFNC at a flow rate of 2 L/kg/min vs. CPAP pressure set at 6-8 cm H 2 O.
Measurements and main results: In each stratum, eligible infants will be randomly allocated on a 1:1 basis to the trial treatments using a web-based system by permuted block randomization, stratified by site of recruitment and age (< 6 wk and ≥ 6 wk). Due to the emergency nature of the treatments, written informed consent will be deferred. The primary outcome is time from randomization to hospital discharge within 30 days. Baseline clinical characteristics and hospital course, including details of respiratory support, and discharge and cost-effectiveness outcomes will be collected. The trial received Health Research Authority and Research Ethics Committee approval from the Yorkshire and The Humber-South Yorkshire Research Ethics Committee on August 3, 2023 (reference: 23/YH/0166). The trial registration is ISRCTN52937119.
Conclusions: Trial findings will be disseminated in national and international conferences, in peer-reviewed journals and through social media.
目的:儿童毛细支气管炎呼吸辅助(BACHb)试验旨在评估高流量鼻插管(HFNC)治疗中度毛细支气管炎的临床和成本效益,与湿化标准氧(HSO)治疗中度毛细支气管炎的婴儿,以及HFNC联合持续气道正压通气(CPAP)治疗重度毛细支气管炎的临床和成本效益。设计:实用、组序、两层、多中心、开放标签随机临床试验。环境:横跨英格兰、苏格兰和威尔士的50家医院。患者:小于12个月的住院婴儿,临床诊断为细支气管炎,间隔至少15分钟评估两次,以满足严重细支气管炎(呼吸频率bbb70次/分,咕噜声,明显胸部萎缩,复发性短呼吸暂停中的一项或多项)或中度细支气管炎(低流量氧缺乏反应,表现为持续低氧血症和/或中度呼吸窘迫)的标准。干预措施:“中度细支气管炎地层”:HFNC流速为2l /kg/min vs. HSO通过面罩或头箱流速高达15l /min。“重度细支气管炎地层”:HFNC流速为2l /kg/min, CPAP压力为6- 8cm H2O。测量结果和主要结果:在每个阶层中,符合条件的婴儿将使用基于网络的系统,按招募地点和年龄(< 6周和≥6周)按1:1的比例随机分配到试验治疗中。由于治疗的紧急性质,书面知情同意将被推迟。主要终点是从随机分组到30天内出院的时间。基线临床特征和住院过程,包括呼吸支持的细节,出院和成本效益结果将被收集。该试验于2023年8月3日获得了约克郡和亨伯-南约克郡研究伦理委员会的卫生研究管理局和研究伦理委员会的批准(参考文献:23/YH/0166)。试验注册号为ISRCTN52937119。结论:试验结果将在国内和国际会议、同行评议期刊和社交媒体上传播。
{"title":"Protocol for a Group-Sequential Two-Stratum Multicenter Open-Label Randomized Clinical Trial of Respiratory Support in Infants With Acute Bronchiolitis: Breathing Assistance in Children With Bronchiolitis (BACHb).","authors":"Isabel Johnson, Katy Bridges, Richard Cleaver, Rayka Malek, Mary Cross, Steve Cunningham, Katrina Cathie, Mark D Lyttle, Rebecca Mitting, Paul Mouncey, Damian Roland, Stephen Turner, Olu Onyimadu, Stavros Petrou, Debra Quantrill, Kate Chadwick, Leila Janani, Padmanabhan Ramnarayan","doi":"10.1097/PCC.0000000000003813","DOIUrl":"10.1097/PCC.0000000000003813","url":null,"abstract":"<p><strong>Objectives: </strong>The Breathing Assistance in Children with bronchiolitis (BACHb) trial aims to evaluate the clinical and cost-effectiveness of high-flow nasal cannula (HFNC) therapy compared with humidified standard oxygen (HSO) in infants with moderate bronchiolitis, and HFNC with continuous positive airway pressure (CPAP) in severe bronchiolitis.</p><p><strong>Design: </strong>Pragmatic, group-sequential, two-stratum, multicenter, open-label randomized clinical trial.</p><p><strong>Setting: </strong>Fifty hospitals across England, Scotland, and Wales.</p><p><strong>Patients: </strong>Hospitalized infants younger than 12 months old with a clinical diagnosis of bronchiolitis, assessed at least twice 15 minutes apart to fulfill criteria for either severe bronchiolitis (one or more of: respiratory rate > 70 breaths/min, grunting, marked chest recession, recurrent short apneas) or moderate bronchiolitis (lack of response to low-flow oxygen, indicated by persistent hypoxemia and/or moderate respiratory distress).</p><p><strong>Interventions: </strong>\"Moderate bronchiolitis stratum\": HFNC at a flow rate of 2 L/kg/min vs. HSO through a facemask or headbox at a flow rate up to 15 L/min. \"Severe bronchiolitis stratum\": HFNC at a flow rate of 2 L/kg/min vs. CPAP pressure set at 6-8 cm H 2 O.</p><p><strong>Measurements and main results: </strong>In each stratum, eligible infants will be randomly allocated on a 1:1 basis to the trial treatments using a web-based system by permuted block randomization, stratified by site of recruitment and age (< 6 wk and ≥ 6 wk). Due to the emergency nature of the treatments, written informed consent will be deferred. The primary outcome is time from randomization to hospital discharge within 30 days. Baseline clinical characteristics and hospital course, including details of respiratory support, and discharge and cost-effectiveness outcomes will be collected. The trial received Health Research Authority and Research Ethics Committee approval from the Yorkshire and The Humber-South Yorkshire Research Ethics Committee on August 3, 2023 (reference: 23/YH/0166). The trial registration is ISRCTN52937119.</p><p><strong>Conclusions: </strong>Trial findings will be disseminated in national and international conferences, in peer-reviewed journals and through social media.</p>","PeriodicalId":19760,"journal":{"name":"Pediatric Critical Care Medicine","volume":" ","pages":"e1275-e1285"},"PeriodicalIF":4.5,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12502951/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144855963","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-10-01Epub Date: 2025-08-12DOI: 10.1097/PCC.0000000000003812
Yulia Shtanko, Abhinav Totapally, Prithvi Sendi, Balagangadhar R Totapally
{"title":"B-Type Natriuretic Peptide in Critically Ill Children: Single-Center Retrospective Study of Levels in the First 72 Hours of PICU Admission and Outcome.","authors":"Yulia Shtanko, Abhinav Totapally, Prithvi Sendi, Balagangadhar R Totapally","doi":"10.1097/PCC.0000000000003812","DOIUrl":"10.1097/PCC.0000000000003812","url":null,"abstract":"","PeriodicalId":19760,"journal":{"name":"Pediatric Critical Care Medicine","volume":" ","pages":"e1307-e1309"},"PeriodicalIF":4.5,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144822194","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-10-01Epub Date: 2025-08-15DOI: 10.1097/PCC.0000000000003811
Amanda O'Halloran, James Sannino, Cheryl Dominick, Christine Bailey, Lori Boyle, Lindsay N Shepard, Vinay Nadkarni, Heather Wolfe, Ryan W Morgan, Akira Nishisaki, Meghan Lane-Fall, Robert Sutton
Objectives: Excessive ventilation adversely affects cardiopulmonary resuscitation (CPR) hemodynamics and outcomes. Pediatric providers rarely achieve guideline-recommended CPR ventilation rates. We aimed to use human factors engineering to design a metronome to improve compliance with recommended CPR ventilation rates. We hypothesized that in usability testing, our novel metronome would achieve: 1) a System Usability Scale (SUS) score greater than 68 and 2) greater than 70% of CPR epochs with ventilation rates within target range, which would be sufficient to support a pilot trial in our PICU.
Measurements and main results: We elicited clinician feedback on the proposed ventilation rate metronome with a survey. Participatory design sessions determined optimal metronome components. During high-fidelity simulation usability testing, we collected qualitative and quantitative measures reflecting participant feedback and performance. Average ventilation rates were calculated during 30-second epochs of CPR, with average rates ± 2 breaths/min (bpm) from the target considered to be within goal range. Among 107 survey respondents, perceptions of appropriateness, acceptability, and feasibility of the ventilation rate metronome were favorable. The final prototype used a bell sound for high saliency in noisy environments and a scrolling timed vertical bar, with pre-set options for three guideline-recommended CPR ventilation rates (infants: 30 bpm, children 1-17 yr old: 20 bpm, adults: 10 bpm). In usability testing (three groups, 34 clinicians), median SUS was 92.5 of 100 (interquartile range, 89.4-93.1), with 0 attributable errors. Overall, 34 of 36 (94% [95% CI, 81-99%]) epochs of simulated CPR with metronome use had ventilation rates ± 2 bpm from the target rate.
Conclusions: Utilizing human factors engineering and implementation science, we successfully designed a novel ventilation rate metronome. When deployed during high-fidelity cardiac arrest simulations, metronome use had high usability scores and resulted in excellent compliance with recommended ventilation rates.
{"title":"Development of a Novel Cardiac Arrest Ventilation Rate Metronome: A Human Factors and Implementation Science Mixed-Methods Approach.","authors":"Amanda O'Halloran, James Sannino, Cheryl Dominick, Christine Bailey, Lori Boyle, Lindsay N Shepard, Vinay Nadkarni, Heather Wolfe, Ryan W Morgan, Akira Nishisaki, Meghan Lane-Fall, Robert Sutton","doi":"10.1097/PCC.0000000000003811","DOIUrl":"10.1097/PCC.0000000000003811","url":null,"abstract":"<p><strong>Objectives: </strong>Excessive ventilation adversely affects cardiopulmonary resuscitation (CPR) hemodynamics and outcomes. Pediatric providers rarely achieve guideline-recommended CPR ventilation rates. We aimed to use human factors engineering to design a metronome to improve compliance with recommended CPR ventilation rates. We hypothesized that in usability testing, our novel metronome would achieve: 1) a System Usability Scale (SUS) score greater than 68 and 2) greater than 70% of CPR epochs with ventilation rates within target range, which would be sufficient to support a pilot trial in our PICU.</p><p><strong>Design: </strong>Prospective single-center mixed-methods study.</p><p><strong>Setting: </strong>Seventy-five-bed academic PICU.</p><p><strong>Participants: </strong>Multidisciplinary clinicians.</p><p><strong>Interventions: </strong>None.</p><p><strong>Measurements and main results: </strong>We elicited clinician feedback on the proposed ventilation rate metronome with a survey. Participatory design sessions determined optimal metronome components. During high-fidelity simulation usability testing, we collected qualitative and quantitative measures reflecting participant feedback and performance. Average ventilation rates were calculated during 30-second epochs of CPR, with average rates ± 2 breaths/min (bpm) from the target considered to be within goal range. Among 107 survey respondents, perceptions of appropriateness, acceptability, and feasibility of the ventilation rate metronome were favorable. The final prototype used a bell sound for high saliency in noisy environments and a scrolling timed vertical bar, with pre-set options for three guideline-recommended CPR ventilation rates (infants: 30 bpm, children 1-17 yr old: 20 bpm, adults: 10 bpm). In usability testing (three groups, 34 clinicians), median SUS was 92.5 of 100 (interquartile range, 89.4-93.1), with 0 attributable errors. Overall, 34 of 36 (94% [95% CI, 81-99%]) epochs of simulated CPR with metronome use had ventilation rates ± 2 bpm from the target rate.</p><p><strong>Conclusions: </strong>Utilizing human factors engineering and implementation science, we successfully designed a novel ventilation rate metronome. When deployed during high-fidelity cardiac arrest simulations, metronome use had high usability scores and resulted in excellent compliance with recommended ventilation rates.</p>","PeriodicalId":19760,"journal":{"name":"Pediatric Critical Care Medicine","volume":" ","pages":"e1264-e1274"},"PeriodicalIF":4.5,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12439253/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144855962","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-10-01Epub Date: 2025-08-05DOI: 10.1097/PCC.0000000000003808
Michelle R Mayeda, Samuel Rosenblatt, Dorene F Balmer, Wynne Morrison, Paula Magee, Veronica Kirchner, Nadir Yehya
Objectives: To determine whether patient race, ethnicity, preferred language, insurance type, and social deprivation index (SDI) are associated with differences in caregiver presence in the PICU and to explore caregiver perspectives on decision-making about time spent at and away from bedside.
Design: Single-center prospective, concurrent mixed-methods study including: 1) a quantitative point prevalence study of caregiver bedside presence, and 2) a qualitative study of interviews with caregivers.
Setting: Seventy-five-bed PICU in a quaternary children's hospital in Philadelphia, PA.
Patients: Over the period 2022-2023, we enrolled: 1) children with anticipated moderate-to-long PICU length of stay and 2) adult caregivers of children in our PICU.
Interventions: None.
Measurements and main results: Multivariable regression tested associations between caregiver presence and race, ethnicity, preferred language, insurance type, and SDI. Semi-structured interviews with caregivers were evaluated using thematic analysis. Among 159 subjects, Black patient race relative to White, and public insurance relative to private, were associated with 18 and 10 fewer hours of caregiver presence during a 48-hour period, respectively. Caregivers nearly universally shared a desire to be present, yet the ability to be present was affected by practical limitations, including job flexibility and family availability.
Conclusions: Public insurance and Black patient race were associated with decreased caregiver presence, disparities that may be explained by practical limitations. Additional work is necessary to explore ways to mitigate barriers to presence and equitable family-centered care and to investigate potential impacts of caregiver presence on health outcomes.
{"title":"Presence of Families at the Bedside in the PICU: Prospective, Mixed-Methods Study of Race and Insurance Disparities.","authors":"Michelle R Mayeda, Samuel Rosenblatt, Dorene F Balmer, Wynne Morrison, Paula Magee, Veronica Kirchner, Nadir Yehya","doi":"10.1097/PCC.0000000000003808","DOIUrl":"10.1097/PCC.0000000000003808","url":null,"abstract":"<p><strong>Objectives: </strong>To determine whether patient race, ethnicity, preferred language, insurance type, and social deprivation index (SDI) are associated with differences in caregiver presence in the PICU and to explore caregiver perspectives on decision-making about time spent at and away from bedside.</p><p><strong>Design: </strong>Single-center prospective, concurrent mixed-methods study including: 1) a quantitative point prevalence study of caregiver bedside presence, and 2) a qualitative study of interviews with caregivers.</p><p><strong>Setting: </strong>Seventy-five-bed PICU in a quaternary children's hospital in Philadelphia, PA.</p><p><strong>Patients: </strong>Over the period 2022-2023, we enrolled: 1) children with anticipated moderate-to-long PICU length of stay and 2) adult caregivers of children in our PICU.</p><p><strong>Interventions: </strong>None.</p><p><strong>Measurements and main results: </strong>Multivariable regression tested associations between caregiver presence and race, ethnicity, preferred language, insurance type, and SDI. Semi-structured interviews with caregivers were evaluated using thematic analysis. Among 159 subjects, Black patient race relative to White, and public insurance relative to private, were associated with 18 and 10 fewer hours of caregiver presence during a 48-hour period, respectively. Caregivers nearly universally shared a desire to be present, yet the ability to be present was affected by practical limitations, including job flexibility and family availability.</p><p><strong>Conclusions: </strong>Public insurance and Black patient race were associated with decreased caregiver presence, disparities that may be explained by practical limitations. Additional work is necessary to explore ways to mitigate barriers to presence and equitable family-centered care and to investigate potential impacts of caregiver presence on health outcomes.</p>","PeriodicalId":19760,"journal":{"name":"Pediatric Critical Care Medicine","volume":" ","pages":"e1253-e1263"},"PeriodicalIF":4.5,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144775975","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-10-01Epub Date: 2025-09-12DOI: 10.1097/PCC.0000000000003822
Marisa Tucci, Avishay Sarfatti, Stéphane Leteurtre, Geneviève Du Pont-Thibodeau, Patricia Fontela, Samiran Ray, Simon J Stanworth, Paul C Hébert, Nadia Roumeliotis, Michaël Sauthier, Philip C Spinella, Thierry Ducruet, Philippe Jouvet, Benoît Mâsse, Nancy Robitaille, Helen Trottier, Jacques Lacroix
Objectives: To evaluate the feasibility of conducting a large international electronic health record-enabled randomized controlled trial (RCT) designed to compare two strategies for RBC transfusion (RBCT) in almost all anemic critically ill children, and the ability to support data abstraction from electronic medical data monitoring systems (eMDMSs).
Design: Two-arm parallel design pilot RCT.
Setting: Four university-affiliated PICUs in Canada, France, and United Kingdom.
Patients: Non-cyanotic critically ill children with hemoglobin (Hb) less than or equal to 9.5 g/dL.
Interventions: Participants were randomly allocated to a restrictive strategy (no RBCT if Hb ≥ 7.0 g/dL) or to usual care (clinician discretion for RBCT).
Measurements and main results: Feasibility outcomes were recruitment, adherence, separation of pre-RBCT Hb, and electronic data extraction from eMDMS. The proportion of patients with Hb less than or equal to 9.5 g/dL who were eligible for consent to participate in Pilot-Optimizing Transfusion Therapy in Critically Ill Children With Anemia (P-OpTTICCA) was 83% (feasibility criterion: ≥ 80%). We enrolled 120 patients, 63 in the restrictive and 57 in the usual care arms. We reached the planned recruitment rate (≥ 2 participants/wk in sites with > 800 admissions/yr, ≥ 1 in other sites). The pre-RBCT Hb concentration was 6.6 ± 7 and 6.7 ± 1.3 g/dL in the restrictive and usual care arms, respectively (separation = 0.1 g/dL; desired difference ≥ 1.0 g/dL). The pre-transfusion Hb concentration was greater than or equal to 7.0 g/dL for 6 of 20 RBCT (30%) given to patients allocated to the restrictive arm (success criterion for protocol adherence: < 20%). There were two protocol deviations, but no protocol violation. Using eMDMS, 87.7% of the 390 data elements in the case report form were extracted and/or calculated electronically (success criterion: > 80%).
Conclusions: P-OpTTICCA demonstrated the feasibility of recruitment, adherence, and electronic data extraction, but we did not get a good separation of pre-RBCT Hb. Future trials need to clearly define transfusion Hb thresholds in both trial arms (NCT03871244).
{"title":"Pilot-Optimizing Transfusion Therapy in Critically Ill Children With Anemia: A Pilot Multicenter Electronic Health Record-Enabled Randomized Controlled Trial on Red Blood Cell Transfusion in Critically Ill Children.","authors":"Marisa Tucci, Avishay Sarfatti, Stéphane Leteurtre, Geneviève Du Pont-Thibodeau, Patricia Fontela, Samiran Ray, Simon J Stanworth, Paul C Hébert, Nadia Roumeliotis, Michaël Sauthier, Philip C Spinella, Thierry Ducruet, Philippe Jouvet, Benoît Mâsse, Nancy Robitaille, Helen Trottier, Jacques Lacroix","doi":"10.1097/PCC.0000000000003822","DOIUrl":"10.1097/PCC.0000000000003822","url":null,"abstract":"<p><strong>Objectives: </strong>To evaluate the feasibility of conducting a large international electronic health record-enabled randomized controlled trial (RCT) designed to compare two strategies for RBC transfusion (RBCT) in almost all anemic critically ill children, and the ability to support data abstraction from electronic medical data monitoring systems (eMDMSs).</p><p><strong>Design: </strong>Two-arm parallel design pilot RCT.</p><p><strong>Setting: </strong>Four university-affiliated PICUs in Canada, France, and United Kingdom.</p><p><strong>Patients: </strong>Non-cyanotic critically ill children with hemoglobin (Hb) less than or equal to 9.5 g/dL.</p><p><strong>Interventions: </strong>Participants were randomly allocated to a restrictive strategy (no RBCT if Hb ≥ 7.0 g/dL) or to usual care (clinician discretion for RBCT).</p><p><strong>Measurements and main results: </strong>Feasibility outcomes were recruitment, adherence, separation of pre-RBCT Hb, and electronic data extraction from eMDMS. The proportion of patients with Hb less than or equal to 9.5 g/dL who were eligible for consent to participate in Pilot-Optimizing Transfusion Therapy in Critically Ill Children With Anemia (P-OpTTICCA) was 83% (feasibility criterion: ≥ 80%). We enrolled 120 patients, 63 in the restrictive and 57 in the usual care arms. We reached the planned recruitment rate (≥ 2 participants/wk in sites with > 800 admissions/yr, ≥ 1 in other sites). The pre-RBCT Hb concentration was 6.6 ± 7 and 6.7 ± 1.3 g/dL in the restrictive and usual care arms, respectively (separation = 0.1 g/dL; desired difference ≥ 1.0 g/dL). The pre-transfusion Hb concentration was greater than or equal to 7.0 g/dL for 6 of 20 RBCT (30%) given to patients allocated to the restrictive arm (success criterion for protocol adherence: < 20%). There were two protocol deviations, but no protocol violation. Using eMDMS, 87.7% of the 390 data elements in the case report form were extracted and/or calculated electronically (success criterion: > 80%).</p><p><strong>Conclusions: </strong>P-OpTTICCA demonstrated the feasibility of recruitment, adherence, and electronic data extraction, but we did not get a good separation of pre-RBCT Hb. Future trials need to clearly define transfusion Hb thresholds in both trial arms (NCT03871244).</p>","PeriodicalId":19760,"journal":{"name":"Pediatric Critical Care Medicine","volume":" ","pages":"e1218-e1230"},"PeriodicalIF":4.5,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145040780","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-10-01Epub Date: 2025-08-06DOI: 10.1097/PCC.0000000000003807
Chen Yun Goh, Karen Ka Yan Leung, Jia Yueh Chong, Xuemei Zhu, Nattachai Anantasit, Lijia Fan, Chunfeng Liu, Louise Ngu, Kam Lun Ellis Hon, Jan Hau Lee, Wei Xu, Hiroshi Kurosawa, Dyah Kanya Wati, Rujipat Samransamruajkit, Li Huang, Muralidharan Jayashree, Yek Kee Chor, Hongxing Dang, Chin Seng Gan, Kah Min Pon, Chian Wern Tai, Phuc Huu Phan, Kazunori Aoki, Felix Liauw, Soo Lin Chuah, Suparyatha Ida Bagus Gede, Pei Chuen Lee, Jacqueline Soo May Ong, Siew Wah Lee, Chengsi Ong, Rehena Sultana, Judith Ju-Ming Wong
Objectives: In this non-prespecified secondary analysis of the PARDSAsia (NCT04068038) 2017-2023 dataset, we describe baseline nutrition status of children with pediatric acute respiratory distress syndrome (PARDS) and determine its association with positive end expiratory pressure (PEEP) during ventilation and mortality. We hypothesized that abnormal nutritional status was associated with adverse outcomes.
Design: The dataset included anthropometric and nutritional data, and body mass index (BMI) z scores were obtained using the World Health Organization standards. Underweight is BMI z score less than -1 and overweight is BMI z score greater than +1. PEEP and F io2 combinations, by the standard grid, in underweight, overweight and normal nutrition groups were compared. Cox proportional hazard regression tested the association between nutrition status and 60-day mortality.
Setting: Twenty-one PICUs across Asia, 2017-2023.
Patients: PARDSAsia patients met the 2015 International Guidelines for the Diagnosis and Management of PARDS (PALICC) criteria.
Interventions: None.
Measurements and main results: Overall, of 693 PARDSAsia patients, we included 625 cases comprising 261 of 625 (41.8%) underweight, 235 of 625 (37.6%) normal, and 129 of 625 (20.6%) overweight patients. Being underweight compared with normal or overweight status, was associated with younger median (interquartile range) age: respectively, 1.0 (0.3, 3.7) vs. 1.4 (0.5, 4.6) vs. 1.9 (0.7, 8.5) years ( p < 0.001). The prescription of PEEP was more conservative in patients who were underweight compared with patients of normal or overweight nutritional status: PEEP/F io2 combinations were, respectively, -1.7 (-3.3, 0.0) vs. -0.9 (-2.7, 0.0) vs. -0.6 (-1.8, 0.4) cm H 2 O below recommended grid value ( p < 0.001). Underweight nutritional status was associated with greater risk of 60-day mortality (adjusted hazard ratio 1.85 [95% CI, 1.14-3.01]).
Conclusions: Underweight nutritional status was prevalent among children within the PARDSAsia 2017-2023 dataset and was associated with poor clinical outcomes. The prescription of PEEP was more conservative in underweight patients compared with those with normal or overweight status.
{"title":"Nutritional Status and Mechanical Ventilation Practices in Pediatric Acute Respiratory Distress Syndrome: A Secondary Analysis of the 2017-2023 PARDSAsia Study.","authors":"Chen Yun Goh, Karen Ka Yan Leung, Jia Yueh Chong, Xuemei Zhu, Nattachai Anantasit, Lijia Fan, Chunfeng Liu, Louise Ngu, Kam Lun Ellis Hon, Jan Hau Lee, Wei Xu, Hiroshi Kurosawa, Dyah Kanya Wati, Rujipat Samransamruajkit, Li Huang, Muralidharan Jayashree, Yek Kee Chor, Hongxing Dang, Chin Seng Gan, Kah Min Pon, Chian Wern Tai, Phuc Huu Phan, Kazunori Aoki, Felix Liauw, Soo Lin Chuah, Suparyatha Ida Bagus Gede, Pei Chuen Lee, Jacqueline Soo May Ong, Siew Wah Lee, Chengsi Ong, Rehena Sultana, Judith Ju-Ming Wong","doi":"10.1097/PCC.0000000000003807","DOIUrl":"10.1097/PCC.0000000000003807","url":null,"abstract":"<p><strong>Objectives: </strong>In this non-prespecified secondary analysis of the PARDSAsia (NCT04068038) 2017-2023 dataset, we describe baseline nutrition status of children with pediatric acute respiratory distress syndrome (PARDS) and determine its association with positive end expiratory pressure (PEEP) during ventilation and mortality. We hypothesized that abnormal nutritional status was associated with adverse outcomes.</p><p><strong>Design: </strong>The dataset included anthropometric and nutritional data, and body mass index (BMI) z scores were obtained using the World Health Organization standards. Underweight is BMI z score less than -1 and overweight is BMI z score greater than +1. PEEP and F io2 combinations, by the standard grid, in underweight, overweight and normal nutrition groups were compared. Cox proportional hazard regression tested the association between nutrition status and 60-day mortality.</p><p><strong>Setting: </strong>Twenty-one PICUs across Asia, 2017-2023.</p><p><strong>Patients: </strong>PARDSAsia patients met the 2015 International Guidelines for the Diagnosis and Management of PARDS (PALICC) criteria.</p><p><strong>Interventions: </strong>None.</p><p><strong>Measurements and main results: </strong>Overall, of 693 PARDSAsia patients, we included 625 cases comprising 261 of 625 (41.8%) underweight, 235 of 625 (37.6%) normal, and 129 of 625 (20.6%) overweight patients. Being underweight compared with normal or overweight status, was associated with younger median (interquartile range) age: respectively, 1.0 (0.3, 3.7) vs. 1.4 (0.5, 4.6) vs. 1.9 (0.7, 8.5) years ( p < 0.001). The prescription of PEEP was more conservative in patients who were underweight compared with patients of normal or overweight nutritional status: PEEP/F io2 combinations were, respectively, -1.7 (-3.3, 0.0) vs. -0.9 (-2.7, 0.0) vs. -0.6 (-1.8, 0.4) cm H 2 O below recommended grid value ( p < 0.001). Underweight nutritional status was associated with greater risk of 60-day mortality (adjusted hazard ratio 1.85 [95% CI, 1.14-3.01]).</p><p><strong>Conclusions: </strong>Underweight nutritional status was prevalent among children within the PARDSAsia 2017-2023 dataset and was associated with poor clinical outcomes. The prescription of PEEP was more conservative in underweight patients compared with those with normal or overweight status.</p>","PeriodicalId":19760,"journal":{"name":"Pediatric Critical Care Medicine","volume":" ","pages":"e1242-e1252"},"PeriodicalIF":4.5,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144789637","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-10-01Epub Date: 2025-08-08DOI: 10.1097/PCC.0000000000003804
Leslie A Dervan, Mary Hartman, Ericka L Fink, Julie C Fitzgerald, Trevor A Hall, Krista Laux, Lindsey A Morgan, Sarah Murphy, Neethi P Pinto, Elisabeth Schrock, Jane E Whitney, Cydni N Williams, Elizabeth Y Killien
Objectives: Children surviving critical illness are at risk for new morbidities collectively termed "post-intensive care syndrome-pediatrics" (PICS-p). Because PICU teams are familiar with PICS-p and motivated to improve patient outcomes, intensivists are ideally positioned to improve access to PICU follow-up care. We aimed to describe various models of care developed by existing U.S. PICU follow-up programs.
Design: The Pediatric Outcomes Studies after PICU (POST-PICU) subgroup of the Pediatric Acute Lung Injury and Sepsis Investigators network convened a virtual meeting with presentations and discussion by 11 leaders of eight follow-up programs, structured using input from the 125 POST-PICU members including advance questions.
Setting: Ninety-minute virtual meeting, September 2024. We recorded and transcribed the presentations and discussion to draft this report.
Panel proceedings: Each leader presented their program and participated in discussion, organized into three domains based on the provided questions: 1) the program's target population and interventions; 2) program administration and funding; and 3) program outcomes. Each program aimed to identify patients considered at-risk for physiologic, neurologic, and/or psychologic PICU sequelae and to provide screening, referral to supportive or specialist services as indicated, and collaboration with their existing healthcare teams. Funding influenced program structure and processes. Many programs provided clinical services alongside services tied to research efforts. Tracking program outcomes helped programs advocate for long-term funding and institutional support. Panelists described their programs as providing "wraparound care," "transition care," and "connection"-supporting patients and families through different stages of the PICU and hospital stay, rehabilitation, and transition to home care.
Conclusions: This information can support PICU teams in developing infrastructure to provide clinically indicated education, screening, and support for their patients, as the PICU community engages in further research and advocacy to improve access to PICU follow-up care.
{"title":"Eight PICU Follow-Up Programs in the United States Established From 2013 to 2022: Report From the Pediatric Outcomes Studies After PICU (POST-PICU) Investigators.","authors":"Leslie A Dervan, Mary Hartman, Ericka L Fink, Julie C Fitzgerald, Trevor A Hall, Krista Laux, Lindsey A Morgan, Sarah Murphy, Neethi P Pinto, Elisabeth Schrock, Jane E Whitney, Cydni N Williams, Elizabeth Y Killien","doi":"10.1097/PCC.0000000000003804","DOIUrl":"10.1097/PCC.0000000000003804","url":null,"abstract":"<p><strong>Objectives: </strong>Children surviving critical illness are at risk for new morbidities collectively termed \"post-intensive care syndrome-pediatrics\" (PICS-p). Because PICU teams are familiar with PICS-p and motivated to improve patient outcomes, intensivists are ideally positioned to improve access to PICU follow-up care. We aimed to describe various models of care developed by existing U.S. PICU follow-up programs.</p><p><strong>Design: </strong>The Pediatric Outcomes Studies after PICU (POST-PICU) subgroup of the Pediatric Acute Lung Injury and Sepsis Investigators network convened a virtual meeting with presentations and discussion by 11 leaders of eight follow-up programs, structured using input from the 125 POST-PICU members including advance questions.</p><p><strong>Setting: </strong>Ninety-minute virtual meeting, September 2024. We recorded and transcribed the presentations and discussion to draft this report.</p><p><strong>Panel proceedings: </strong>Each leader presented their program and participated in discussion, organized into three domains based on the provided questions: 1) the program's target population and interventions; 2) program administration and funding; and 3) program outcomes. Each program aimed to identify patients considered at-risk for physiologic, neurologic, and/or psychologic PICU sequelae and to provide screening, referral to supportive or specialist services as indicated, and collaboration with their existing healthcare teams. Funding influenced program structure and processes. Many programs provided clinical services alongside services tied to research efforts. Tracking program outcomes helped programs advocate for long-term funding and institutional support. Panelists described their programs as providing \"wraparound care,\" \"transition care,\" and \"connection\"-supporting patients and families through different stages of the PICU and hospital stay, rehabilitation, and transition to home care.</p><p><strong>Conclusions: </strong>This information can support PICU teams in developing infrastructure to provide clinically indicated education, screening, and support for their patients, as the PICU community engages in further research and advocacy to improve access to PICU follow-up care.</p>","PeriodicalId":19760,"journal":{"name":"Pediatric Critical Care Medicine","volume":" ","pages":"e1296-e1306"},"PeriodicalIF":4.5,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144799853","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-09-01Epub Date: 2025-08-06DOI: 10.1097/PCC.0000000000003800
James D Fortenberry
{"title":"A Tale of Two Subphenotypes in Pediatric Sepsis-Associated Acute Kidney Injury.","authors":"James D Fortenberry","doi":"10.1097/PCC.0000000000003800","DOIUrl":"10.1097/PCC.0000000000003800","url":null,"abstract":"","PeriodicalId":19760,"journal":{"name":"Pediatric Critical Care Medicine","volume":" ","pages":"e1165-e1167"},"PeriodicalIF":4.5,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144789636","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}