重症监护病房住院患者预防压疮的翻身频率：一项整群随机对照试验方案
Frequency of repositioning for preventing pressure ulcers in patients hospitalized in ICU: protocol of a cluster randomized controlled trial.
作者信息
Cortés Olga L, Herrera-Galindo Mauricio, Villar Juan Carlos, Rojas Yudi A, Del Pilar Paipa María, Salazar Luzdary
机构信息
Research Unit & Nursing Department, Fundación Cardioinfantil-Instituto de Cardiología, Cl. 163a #13B-60, Bogotá D. C, Colombia.
Faculty of Health Sciences, Universidad Autónoma de Bucaramanga, Bucaramanga, Colombia, Avenida 42 No 48-11PBX.
出版信息
BMC Nurs. 2021 Jul 5;20(1):121. doi: 10.1186/s12912-021-00616-0.
BACKGROUND
Despite being considered preventable, ulcers due to pressure affect between 30 and 50% of patients at high and very high risk and susceptibility, especially those hospitalized under critical care. Despite a lack of evidence over the efficacy in prevention against ulcers due to pressure, hourly repositioning in critical care as an intervention is used with more or less frequency to alleviate pressure on patients' tissues. This brings up the objective of our study, which is to evaluate the efficacy in prevention of ulcers due to pressure acquired during hospitalization, specifically regarding two frequency levels of repositioning or manual posture switching in adults hospitalized in different intensive care units in different Colombian hospitals.
METHODS
A nurse-applied cluster randomized controlled trial of parallel groups (two branches), in which 22 eligible ICUs (each consisting of 150 patients), will be randomized to a high-frequency level repositioning intervention or to a conventional care (control group). Patients will be followed until their exit from each cluster. The primary result of this study is originated by regarding pressure ulcers using clusters (number of first ulcers per patient, at the early stage of progression, first one acquired after admission for 1000 days). The secondary results include evaluating the risk index on the patients' level (Hazard ratio, 95% IC) and a description of repositioning complications. Two interim analyses will be performed through the course of this study. A statistical difference between the groups < 0.05 in the main outcome, the progression of ulcers due to pressure (best or worst outcome in the experimental group), will determine whether the study should be put to a halt/determine the termination of the study.
CONCLUSION
This study is innovative in its use of clusters to advance knowledge of the impact of repositioning as a prevention strategy against the appearance of ulcers caused by pressure in critical care patients. The resulting recommendations of this study can be used for future clinical practice guidelines in prevention and safety for patients at risk.
TRIAL REGISTRATION
PENFUP phase-2 was Registered in Clinicaltrials.gov ( NCT04604665 ) in October 2020.
背景
尽管压力性溃疡被认为是可预防的，但在高危和极高风险及易感性患者中，有30%至50%会受到影响，尤其是那些在重症监护下住院的患者。尽管缺乏关于预防压力性溃疡有效性的证据，但在重症监护中每小时进行一次重新定位作为一种干预措施，或多或少地被频繁使用，以减轻对患者组织的压力。这引出了我们研究的目的，即评估在哥伦比亚不同医院的不同重症监护病房住院的成人中，预防住院期间获得性压力性溃疡的有效性，特别是关于两种重新定位频率水平或手动姿势转换。
方法
一项由护士实施的平行组整群随机对照试验（两个分支），其中22个符合条件的重症监护病房（每个病房由150名患者组成）将被随机分配到高频重新定位干预组或常规护理组（对照组）。患者将被随访至离开每个群组。本研究的主要结果源自使用群组来观察压力性溃疡（每位患者在进展早期、入院后1000天内首次出现的溃疡数量）。次要结果包括评估患者层面的风险指数（风险比，95%置信区间）以及重新定位并发症描述。在本研究过程中将进行两次中期分析。主要结局即压力性溃疡的进展（实验组最佳或最差结局）在两组之间的统计学差异<0.05，将决定是否应停止研究/决定研究终止。
结论
本研究在使用群组推进对重新定位作为预防重症监护患者压力性溃疡出现的策略的影响的认识方面具有创新性。本研究得出的建议可用于未来针对高危患者的预防和安全临床实践指南。
试验注册
PENFUP二期于2020年10月在Clinicaltrials.gov注册（NCT04604665）。
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