Acta Anaesthesiologica Scandinavica最新文献

Background: Adult intensive care unit (ICU) patients receive many interventions, but few are supported by high-certainty evidence. Randomised clinical trials (RCTs) are essential for trustworthy comparisons of intervention effects, but conventional RCTs are costly, cumbersome, inflexible, and often turn out inconclusive. Adaptive platform trials may mitigate these issues and have higher probabilities of obtaining conclusive results faster and at lower costs per participant.

Methods: The Intensive Care Platform Trial (INCEPT) is an investigator-initiated, pragmatic, randomised, embedded, multifactorial, international, adaptive platform trial including adults acutely admitted to ICUs. INCEPT will assess comparable groups of interventions (primarily commonly used interventions with clinical uncertainty and practice variation) nested in domains. Interventions may be either open-label or masked. New domains will continuously be added to the platform. INCEPT assesses multiple core outcomes selected following substantial stakeholder involvement: mortality, days alive without life support/out of hospital/free of delirium, health-related quality of life, cognitive function, and safety outcomes. Each domain will use one of these core outcomes as the primary outcome. INCEPT primarily uses Bayesian statistical methods with neutral, minimally informative or sceptical priors, adjustment for important prognostic baseline variables, and calculation of absolute and relative differences in the intention-to-treat populations. Domains and intervention arms may be stopped for superiority/inferiority, practical equivalence, or futility according to pre-specified adaptation rules evaluated using statistical simulation or at pre-specified maximum sample sizes. Domains may use response-adaptive randomisation, meaning that more participants will be allocated to interventions with higher probabilities of being superior.

Conclusions: INCEPT provides an efficient, pragmatic, and flexible platform for comparing the effects of many interventions used in adult ICU patients. The adaptive design enables the trial to use accumulating data to improve the treatment of future participants. INCEPT will provide high-certainty, conclusive evidence for many interventions, directly inform clinical practice, and thus improve patient-important outcomes.

Background: Deep brain stimulation has become the standard of care for refractory Parkinson's disease. Neuroimaging advances have led to image-based targeting of the subthalamic nucleus under general anaesthesia (GA), an approach that renders unnecessary microelectrode recording and stimulation tests under local anaesthesia and conscious sedation (CS). We aimed to compare procedures and incidents related to each anaesthetic approach.

Methods: Retrospective descriptive comparison of deep brain stimulation under CS versus G. We collected patient and procedure data (e.g., comorbidities, difficult airway criteria, intraoperative monitoring, duration of surgery, hospitalization and motor outcomes) and reviewed intraoperative and postoperative haemodynamic, neurologic and surgery-related incidents.

Results: Seventy-eight procedures were analysed, 36 in the CS group (47.4%) and 42 in the GA group (52.6%). One-third of the patients were women, and the median age was 62 years (range, 33-75). In total, 23 patients experienced at least one perioperative incident, 19 (24.4%) in the CS group and 4 (5.1%) in the GA group (p < .001), even though the GA group included higher-risk patients (p < .05). Fourteen patients (17.9%) presented disorientation/agitation, 12 in the CS group (p < .01). The median duration of the surgery was 5.2 h (range, 3.5-9.2 h) in the CS group, split into two sessions, and 4.6 h (range, 4.1-5.2 h) in the GA group (p < .001). The median (interquartile range [IQR]) hospital stay was also longer in the CS group, at 7.5 days (IQR 6.75-10), compared to 3 days (IQR 3-4) in the GA group (p < .0001). Pre- and postoperative movement disorder evaluations for 38 of the 78 patients (49%) showed significantly improved scores after surgery. No differences were found between the two groups either before (p = .41) or after (p = .52) the surgery.

Conclusions: Deep brain stimulation under GA was associated with fewer perioperative incidents, shorter surgeries and shorter hospital stays.

Editorial comment: Patients with Parkinson's disease who are refractory to standard drug therapy may benefit from the implantation of deep-brain stimulating electrodes. In this report, imaging-guided electrode implantation under general anaesthesia was associated with fewer adverse perioperative events as well as shorter procedure times, compared to implantation guided by intraoperative electrode recording and stimulation under conscious sedation. Since imaging- and stimulation-guided implantation confers equal long-term benefits to motor function, the results from the current study suggest that general anaesthesia and imaging-guided implantation represent an overall quality improvement for these patients.

Background: Trauma is a leading cause of death and disability in the pediatric population. CT has gained a key role in the management of pediatric trauma. Recently, there has been an increased focus on limiting exposure to ionizing radiation in pediatric patients. Furthermore, most CT scans performed in the management of pediatric trauma are without clinically relevant findings. Therefore, the proposed scoping review aims to assess the effects of introducing a guideline addressing whether pediatric trauma patients should undergo a CT scan.

Methods: In accordance with the Preferred reporting items for systematic review and meta-analysis extension for scoping reviews (PRISMA-ScR) we will conduct a scoping review assessing the effect of implementing CT-scan guidelines in the management of pediatric trauma. We will examine study design, patient characteristics, details of implemented guidelines, and outcomes across included studies.

Results: Results will be reported both descriptively and in tabulated form.

Conclusion: The proposed scoping review will provide an overview of the published evidence concerning the introduction of CT-scan guidelines for the management of pediatric trauma. This might aid in the implementation of further initiatives to reduce ionizing radiation exposure in the pediatric trauma population.

Background: The number of older patients undergoing surgical procedures with anaesthesia care is projected to rise. In order to cope with the increased demand, the expansion of outpatient surgery may play a decisive role. We aim to investigate the characteristics and outcomes of the older outpatient population.

Patients and methods: The Peri-interventional Outcome Study in the Elderly in Europe (POSE) was a prospective multicenter study investigating characteristics and outcomes in 9497 patients aged 80 years and older undergoing a procedure with anaesthesia care. This secondary analysis of the POSE data investigated characteristics, functional and cognitive outcomes, and mortality in the outpatient in comparison to the inpatient population. Functional status was assessed as independent, partially dependent, and totally dependent at baseline and 30 days postinterventional. Cognitive status was defined by the number of recalled words (0-3) in the Mini-Cog test and brief cognitive screening at baseline and follow-up.

Results: Out of the 9497 older patients, 7562 were planned inpatients and 1935 planned outpatients. Older outpatients presented with fewer comorbidities and fewer medications than older inpatients and underwent minor procedures more often Their baseline functional status was more often independent, and they had a higher estimated probability of staying independent. Outpatients recalled three words at baseline and follow-up more often than inpatients. The estimated 30-day survival probabilities with 95% confidence intervals were 0.997 [0.994; 0.999] in the group with planned outpatient surgery and 0.948 [0.942; 0.953] with planned inpatient surgery.

Conclusion: Our results indicate that functional and cognitive status at baseline and follow-up were higher in planned outpatients than in planned inpatients. However, only short screening tools for the assessment of functional and cognitive status were used. Overall, outpatient interventions were associated with low mortality. Further research is recommended to develop scores that facilitate the identification of patients suitable for outpatient surgery.

Editorial comment: This secondary analysis of a prospectively collected cohort of elderly surgical cases in Europe describes case factors related to inpatient compared to outpatient surgical interventions. The findings show that inpatient or outpatient surgery selection is associated with different degrees of risk for important perioperative outcomes in this cohort.

Background: Nasotracheal intubation is associated with a risk of epistaxis. Decongestion of the nasal mucosa reduces the risk of epistaxis, and different vasoconstrictors may be used. Cocaine has both decongestive and analgesic properties, but it also has side effects. In this systematic review, we aimed to evaluate if cocaine decreases the occurrence and severity of epistaxis when administered topically to the nasal mucosa before nasotracheal intubation.

Methods: We conducted a systematic review and meta-analysis following the PRISMA guidelines based on a predefined protocol. We included randomized clinical trials comparing nasal cocaine to active comparators or placebo for nasotracheal intubation. Two reviewers independently screened studies for eligibility and performed data extraction. Relative risk with 95% confidence intervals was calculated. Predefined primary outcome measures were the occurrence and severity of epistaxis. Secondary outcomes were pain, mechanical complications, and patient-centered side effects. The risk of bias was evaluated using the revised Cochrane Risk of Bias 2 tool for randomized trials, and certainty of evidence on outcome level was assessed according to GRADE.

Results: Six trials (n = 457) were included; one trial was judged as having a low risk of bias. All six trials provided information on the occurrence of epistaxis. The meta-analysis did not support a difference in the occurrence of epistaxis between cocaine and its comparators (fixed effect: relative risk 0.90 [95% confidence interval 0.75 to 1.09, I² of 0%, certainty of evidence: low]). The severity of epistaxis was evaluated on incompatible scales and thus not suitable for meta-analysis. No studies reported on pain or mechanical complications associated with nasotracheal intubation, and data on patient-centered side effects were sparse.

Conclusion: This systematic review with meta-analysis demonstrated that the quantity and certainty of evidence on cocaine used for nasotracheal intubation is low and that there is no firm evidence for the benefits and harms of cocaine compared to other vasoconstrictors and topical analgetics or placebo. Consequently, sufficiently powered randomized trials assessing patient-centered outcomes, including outcomes on side effects, should be conducted before firm conclusions on cocaine for nasotracheal intubation can be drawn.

Editorial comment: Epistaxis can occur with nasotracheal intubation, and topical drug vasoconstrictor effects have been used to reduce this risk. This analysis shows that the evidence base supporting the use of cocaine for reducing the risk of epistaxis in nasotracheal intubation is uncertain.

Introduction: Non-steroidal anti-inflammatory drugs (NSAIDs) are recommended for pain treatment after elective hip and knee arthroplasties. However, evidence regarding the incidence of adverse effects with short-term NSAID treatment following surgery is limited. We, therefore, aim to assess the adverse effects with an eight-day postoperative treatment with ibuprofen after elective hip and knee arthroplasties.

Methods and analysis: PERISAFE is a randomized, placebo-controlled, blinded multicenter trial with 90-day and one-year follow-up. Eligible patients undergoing elective hip or knee arthroplasty are allocated 1:1 to either ibuprofen 400 mg ×3/day or identical placebo ×3/day for eight days after surgery. The primary outcome is a composite of either death, acute myocardial infarction, stroke, pulmonary embolism, deep venous thrombosis, renal failure, major bleeding, re-operation, gastrointestinal ulcer, or readmission within 90 days postoperatively. Secondary outcomes are hospital-free days within 90 days postoperatively, a composite of ibuprofen and opioid-related adverse reactions based on eight-day postoperative diary, and health related quality of life after 90 days postoperatively. A total of 2904 patients are needed to demonstrate a relative risk reduction of 33% in the placebo group, accepting a risk of type I error of 5% and type II error of 20% and a proportion of serious adverse events in the ibuprofen group of 8%. The primary analysis will be in the modified intention-to-treat population.

Ethics and dissemination: The trial is approved by the Danish Medicine Agency and the Research Ethics Committee (EU CT no. 2022-502, 502-32-00). We plan to submit for publication in a major international peer-reviewed journal and present results at scientific meetings.

Background: Classic teaching is that spinal anesthesia is safe at or below the L2-L3 interspace. To evaluate this, we sought to determine the percentage of individuals with a conus medullaris termination (CMT) level at or below the L1-L2 interspace. Further, the relationship of CMT level to age, sex, body mass index (BMI), and spinal pathology was examined, as was the reliability of using Tuffier's line (TL) as an anatomical landmark.

Methods: This retrospective study evaluated magnetic resonance images of 944 adult patients to determine the CMT level. The relationship between age, sex, height, BMI, and spinal pathology and CMT level was explored by logistic regression. The correspondence of the TL line to the L4-L5 interspace and the presence of overlap with the CMT were examined using 720 lumbar x-rays of the same patient cohort.

Results: Of 944 patients (mean age, 57.8 years; 49% male), 18.9% had CMT at or below the L1-L2 interspace, and spinal anesthesia at the L2-L3 interspace was found to carry a 0.7% incidence of neuraxial risk. Only the presence of congenital spinal abnormalities was found to be significantly predictive of having a CMT at or below the L1-L2 interspace. TL was found to correspond to the L4-L5 interspace in 99.8% of patients with lumbar x-rays.

Conclusions: Spinal anesthesia at the L2-L3 interspace, using TL as an anatomical landmark, is safe in >99% of patients. However, caution must be exercised in all patients as demographic variables were found to be limited in predicting a low CMT level.

Editorial comment: Unlike previous smaller studies, this retrospective study included MRI data from a total of 944 patients. The present study confirms that spinal anesthesia at the L2-L3 interspace or below can be considered safe. The findings indicate that Tuffier's line can be used as a reliable anatomical landmark.

Background: Pharmacokinetics and sedative effects of sublingual dexmedetomidine have not been established in children. The primary aim was to compare peak plasma concentration, time to reach peak plasma concentration and area under the curve with 2 μg/kg sublingual and intranasal dexmedetomidine. The secondary aims were to compare the depth of sedation, parental separation anxiety, mask acceptance, heart rate changes, analgesic requirements and recovery time with 2 μg/kg sublingual and intranasal dexmedetomidine in children.

Method: Thirty children between 2 and 12 years, weighing 10-30 kg, scheduled for surgeries were divided into two groups. Thirty minutes before the induction of anaesthesia, children were premedicated with 2 μg/kg dexmedetomidine either by intranasal drops (Group N) or sublingual wafer (Group S). Five venous blood samples were collected to measure dexmedetomidine plasma concentrations at 15, 30, 45, 60 and 120 min from dexmedetomidine administration. Sedation, parental separation anxiety, mask acceptance and heart rate were recorded. Recovery, pain and fentanyl requirements were assessed.

Results: Demographic data was comparable. Median interquartile range (IQR) dexmedetomidine peak plasma concentration in Group N (0.764 [0.650-0.820]) ng/mL was significantly higher than in Group S (0.593 [0.364-0.754]) ng/mL (p = .014). Plasma concentration was significantly higher at 30 and 45 min in Group N as compared to Group S (p < .05). The median (IQR) time to reach peak plasma concentration was shorter in Group N (45 [45-120]) minutes than in Group S (60 [45-60]) minutes, (p = .814). The median (IQR) area under the concentration-time curve was significantly higher in Group N (1.062 [0.848-1.20]) ng/mL.h in comparison to Group S (0.866 [0.520-1.05]) ng/mL.h (p = .031). Comparable sedation was achieved at 25 min in both groups. No child required treatment for decreased heart rate. Parental separation anxiety, mask acceptance, recovery and analgesic requirements were comparable.

Conclusions: Intranasal 2 μg/kg dexmedetomidine resulted in significantly higher peak plasma concentration and time to reach peak plasma concentration than sublingual wafers. Sublingual and intranasal dexmedetomidine resulted in comparable sedation, parental separation and mask acceptance.

Editorial comment: This study compared the pharmacokinetics and sedative effects of sublingual versus intranasal dexmedetomidine in children, finding that intranasal administration resulted in significantly higher peak plasma concentration and faster time to peak concentration. Both routes achieved comparable sedation, parental separation anxiety scores and mask acceptance, with no significant adverse effects observed.

Background: During rapid sequence induction, either rocuronium 1.0 mg kg^-1 or suxamethonium 1.0 mg kg^-1 can be administered to facilitate endotracheal intubation. We hypothezised that rocuronium provided a larger proportion of excellent intubating conditions compared to suxamethonium in elderly patients.

Methods: A total of 90 patients 80 years or above with American Society of Anesthesiologists physical health Classes I-IV, and a body mass index < 35 kg m^-1-2 were randomised to either rocuronium 1.0 mg kg^-1 or suxamethonium 1.0 mg kg^-1 during rapid sequence induction with intubation using a video laryngoscope. After 60 s, tracheal intubating conditions were evaluated using the Fuchs-Buder scale by a blinded investigator, and the primary outcome was the proportion of patients with excellent intubating conditions. Further outcomes included first pass success rate, intubating conditions according to the intubating difficulty scale (IDS), onset time and postoperative occurrence of muscle soreness, hoarseness and sore throat.

Results: All patients were evaluated for the primary outcome. Excellent intubating conditions occurred in 36 patients (73%) versus 31 (75%) in the rocuronium group and suxamethonium group, respectively (95% confidence interval [CI]: -16 to 20) (p = .82). The first pass success rate was 48 (98%) versus 40 (98%) comparing the rocuronium group with the suxamethonium group, respectively (p = .90). No difference in IDS score was found; median 0 (interquartile ranges [IQR]: 0-1) versus median 0 (IQR: 0-1) (p = .48). Onset time was significantly shorter in the suxamethonium group 99 versus 131 s (p = .01) (95% CI: 7 to 57). Finally, no difference was found in the occurrence of muscle soreness, hoarseness or sore throat postoperatively.

Conclusion: No important difference in intubating conditions was found during rapid sequence induction after the administration of either rocuronium 1.0 mg kg^-1 or suxamethonium 1.0 mg kg^-1 in patients 80 years or above.

Editorial comment: This reports a superiority trial comparing standardised doses of rocuronium and suxamethonium at 60 s for quality of intubating conditions in the rapid sequence context, and this in an elderly cohort. The findings showed no difference between the drugs concerning intubation outcomes, though the onset or time to peak effect was shorter for suxamethonium, again demonstrated in a cohort 80 years old or older.

Aims and objectives: The purpose of this study was to introduce the concept of Tactical Emergency Medical Services (TEMS) in Denmark and to explore the TEMS providers' and the Danish Police Forces' confidence in the TEMS concept in case of a terrorist attack within the Capital Region of Denmark.

Background: Terrorist attacks pose a major challenge to prehospital emergency medical services when it comes to reaching trapped victims. The threat to healthcare professionals limits access and creates a so-called therapeutic vacuum, leading to delayed treatment and evacuation of victims and ultimately increases mortality.

Methods: This study used a mixed methods triangulation approach, integrating qualitative data from an interview study and quantitative data from a register study. The interview study consisted of 18 semistructured interviews conducted across three interview groups (Copenhagen TEMS physicians/paramedics, senior on-site commanders, and tactical and medical officers from the Copenhagen Police Department) with six participants in each group. Data from the interview study were analyzed using thematic framework analysis. The register study used data from the TEMS database, including 61 assignments from 2019 to 2020, that were analyzed using descriptive statistics.

Results: The interview study found three core themes in each interview group. The main findings included insights on the advantages of having healthcare professionals in the warm zone, the prerequisites for the concept's success, TEMS's cooperation with the Danish Police Force, and challenges concerning healthcare providers inside tactical zones. The participants expected TEMS' presence inside the warm zone could improve triage and medical treatment, free police resources, increase police safety, optimize preparedness of the health sector, and significantly reduce the therapeutic vacuum. Data from the register study demonstrated that TEMS have had prior assignments in the warm and hot zones.

Conclusion: All participating groups have high confidence in TEMS to close the gap of the therapeutic vacuum and deliver advanced physician and paramedic-based tactical medicine inside the warm zone in case of a terrorist attack in Copenhagen, Denmark.

Editorial comment: This study includes both provider interviews and registry data to support insight into processes of Tactical Emergency Medicine. The authors discuss possible advantages of having emergency medical personnel in the major incident area early to support a coordinated response.