Lars Krüger , Armin Zittermann , Thomas Mannebach , Franziska Wefer , Tobias Becker , Sarah Lohmeier , Anna Lüttermann , Vera von Dossow , Sebastian V. Rojas , Jan Gummert , Gero Langer
{"title":"评估基础护理对重症监护室住院期间谵妄持续时间影响的随机可行性试验。","authors":"Lars Krüger , Armin Zittermann , Thomas Mannebach , Franziska Wefer , Tobias Becker , Sarah Lohmeier , Anna Lüttermann , Vera von Dossow , Sebastian V. Rojas , Jan Gummert , Gero Langer","doi":"10.1016/j.iccn.2024.103748","DOIUrl":null,"url":null,"abstract":"<div><h3>Objective</h3><p>We tested the feasibility of a randomized controlled trial for comparing primary nursing with standard care.</p></div><div><h3>Research Methodology</h3><p>Elective cardiac surgical patients were eligible for inclusion. Patients with an intensive care unit stay of ≥ 3 days were followed up until intensive care unit discharge. Recruitment period was one year.</p></div><div><h3>Setting</h3><p>Two intensive care units at a university hospital specialized in cardiovascular and diabetic diseases.</p></div><div><h3>Main Outcome Measures</h3><p>Primary outcomes were recruitment and delivery rate. Primary clinical outcome was duration of delirium, as assessed by the Confusion Assessment Method for Intensive Care Units. Secondary outcomes included the incidence of delirium, anxiety (10-point Numeric Rating Scale), and the satisfaction of patient relatives (validated questionnaire).</p></div><div><h3>Results</h3><p>Of 369 patients screened, 269 could be allocated to primary nursing (n = 134) or standard care (n = 135), of whom 46 patients and 48 patients, respectively, underwent an intensive care unit stay ≥ 3 days. Thus, recruitment and delivery rates were 73 and 26 %, respectively. During primary nursing and standard care, 18 and 24 patients developed a delirium, with a median duration of 32 (IQR: 14–96) and 24 (IQR: 8–44) hours (P = 0.10). The risk difference of delirium for primary nursing versus standard care was 11 % and the relative risk was 0.65 (95 % CI: 0.28–1.46; P = 0.29). The extent of anxiety was similar between groups (P = 0.13). Satisfaction could be assessed in 73.5 % of relatives, without substantial differences between groups.</p></div><div><h3>Conclusion</h3><p>Data demonstrate that a trial for comparing primary nursing with standard care is generally feasible. However, the incidence of delirium may be a better primary outcome parameter than delirium duration, both in terms of long-term patient outcome and robustness of data quality.</p></div><div><h3>Implications for clinical practice</h3><p>A randomized clinical trial regarding nursing organization during intensive care unit stay requires detailed planning of patient recruitment, data evaluation, and power calculation.</p></div>","PeriodicalId":51322,"journal":{"name":"Intensive and Critical Care Nursing","volume":null,"pages":null},"PeriodicalIF":4.9000,"publicationDate":"2024-06-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S0964339724001332/pdfft?md5=ccb2c7d4075faa78d2d54d9d30cdb436&pid=1-s2.0-S0964339724001332-main.pdf","citationCount":"0","resultStr":"{\"title\":\"Randomized feasibility trial for evaluating the impact of primary nursing on delirium duration during intensive care unit stay\",\"authors\":\"Lars Krüger , Armin Zittermann , Thomas Mannebach , Franziska Wefer , Tobias Becker , Sarah Lohmeier , Anna Lüttermann , Vera von Dossow , Sebastian V. Rojas , Jan Gummert , Gero Langer\",\"doi\":\"10.1016/j.iccn.2024.103748\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Objective</h3><p>We tested the feasibility of a randomized controlled trial for comparing primary nursing with standard care.</p></div><div><h3>Research Methodology</h3><p>Elective cardiac surgical patients were eligible for inclusion. Patients with an intensive care unit stay of ≥ 3 days were followed up until intensive care unit discharge. Recruitment period was one year.</p></div><div><h3>Setting</h3><p>Two intensive care units at a university hospital specialized in cardiovascular and diabetic diseases.</p></div><div><h3>Main Outcome Measures</h3><p>Primary outcomes were recruitment and delivery rate. Primary clinical outcome was duration of delirium, as assessed by the Confusion Assessment Method for Intensive Care Units. Secondary outcomes included the incidence of delirium, anxiety (10-point Numeric Rating Scale), and the satisfaction of patient relatives (validated questionnaire).</p></div><div><h3>Results</h3><p>Of 369 patients screened, 269 could be allocated to primary nursing (n = 134) or standard care (n = 135), of whom 46 patients and 48 patients, respectively, underwent an intensive care unit stay ≥ 3 days. Thus, recruitment and delivery rates were 73 and 26 %, respectively. During primary nursing and standard care, 18 and 24 patients developed a delirium, with a median duration of 32 (IQR: 14–96) and 24 (IQR: 8–44) hours (P = 0.10). The risk difference of delirium for primary nursing versus standard care was 11 % and the relative risk was 0.65 (95 % CI: 0.28–1.46; P = 0.29). The extent of anxiety was similar between groups (P = 0.13). 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Randomized feasibility trial for evaluating the impact of primary nursing on delirium duration during intensive care unit stay
Objective
We tested the feasibility of a randomized controlled trial for comparing primary nursing with standard care.
Research Methodology
Elective cardiac surgical patients were eligible for inclusion. Patients with an intensive care unit stay of ≥ 3 days were followed up until intensive care unit discharge. Recruitment period was one year.
Setting
Two intensive care units at a university hospital specialized in cardiovascular and diabetic diseases.
Main Outcome Measures
Primary outcomes were recruitment and delivery rate. Primary clinical outcome was duration of delirium, as assessed by the Confusion Assessment Method for Intensive Care Units. Secondary outcomes included the incidence of delirium, anxiety (10-point Numeric Rating Scale), and the satisfaction of patient relatives (validated questionnaire).
Results
Of 369 patients screened, 269 could be allocated to primary nursing (n = 134) or standard care (n = 135), of whom 46 patients and 48 patients, respectively, underwent an intensive care unit stay ≥ 3 days. Thus, recruitment and delivery rates were 73 and 26 %, respectively. During primary nursing and standard care, 18 and 24 patients developed a delirium, with a median duration of 32 (IQR: 14–96) and 24 (IQR: 8–44) hours (P = 0.10). The risk difference of delirium for primary nursing versus standard care was 11 % and the relative risk was 0.65 (95 % CI: 0.28–1.46; P = 0.29). The extent of anxiety was similar between groups (P = 0.13). Satisfaction could be assessed in 73.5 % of relatives, without substantial differences between groups.
Conclusion
Data demonstrate that a trial for comparing primary nursing with standard care is generally feasible. However, the incidence of delirium may be a better primary outcome parameter than delirium duration, both in terms of long-term patient outcome and robustness of data quality.
Implications for clinical practice
A randomized clinical trial regarding nursing organization during intensive care unit stay requires detailed planning of patient recruitment, data evaluation, and power calculation.
期刊介绍:
The aims of Intensive and Critical Care Nursing are to promote excellence of care of critically ill patients by specialist nurses and their professional colleagues; to provide an international and interdisciplinary forum for the publication, dissemination and exchange of research findings, experience and ideas; to develop and enhance the knowledge, skills, attitudes and creative thinking essential to good critical care nursing practice. The journal publishes reviews, updates and feature articles in addition to original papers and significant preliminary communications. Articles may deal with any part of practice including relevant clinical, research, educational, psychological and technological aspects.