Faculty of Medicine, Dentistry and Health Sciences, Melbourne School of Health Sciences, Department of Nursing, The University of Melbourne, Carlton, Victoria, Australia.
The Herbert J. Berman Chair in Vascular Bioengineering, Department of Biomedical Engineering, Faculty of Engineering, Tel Aviv University, Tel Aviv, Israel.
Int Wound J. 2023 Nov;20(9):3567-3579. doi: 10.1111/iwj.14230. Epub 2023 Jun 9.
Pressure injuries affect 13.1% to 45.5% of patients in the intensive care unit and lead to pain and discomfort for patients, burden on healthcare providers, and unnecessary cost to the health system. Turning and positioning systems offer improvements on usual care devices, however the evidence of the effectiveness of such systems is still emerging. We conducted an investigator initiated, prospective, single centre, two group, non-blinded, randomised controlled trial to determine the effectiveness of a system for turning and positioning intensive care unit patients, when compared to usual care turning and positioning devices, for preventing PIs. The trial was prematurely discontinued after enrolment of 78 participants due to COVID-19 pandemic related challenges and lower than expected enrolment rate. The study groups were comparable on baseline characteristics and adherence to the interventions was high. Four participants developed a PI (in the sacral, ischial tuberosity or buttock region), n = 2 each in the intervention and control group. Each participant developed one PI. As the trial is underpowered, these findings do not provide an indication of the clinical effectiveness of the interventions. There was no participant drop-out or withdrawal and there were no adverse events, device deficiencies, or adverse device effects identified or reported. The results of our study (in particular those pertaining to enrolment, intervention adherence and safety) provide considerations for future trials that seek to investigate how to prevent PIs among ICU patients.
压力性损伤影响重症监护病房 13.1%至 45.5%的患者，给患者带来疼痛和不适，给医疗保健提供者带来负担，并给卫生系统带来不必要的成本。翻身和定位系统为常规护理设备提供了改进，然而，这些系统有效性的证据仍在不断涌现。我们进行了一项由研究者发起的、前瞻性的、单中心的、两组的、非盲的、随机对照试验，以确定一种重症监护病房患者翻身和定位系统与常规护理翻身和定位设备相比，预防压力性损伤的有效性。由于 COVID-19 大流行相关挑战和低于预期的入组率，该试验在入组 78 名参与者后提前停止。研究组在基线特征上具有可比性，且对干预措施的依从性较高。4 名参与者（骶骨、坐骨结节或臀部区域）发生压力性损伤，干预组和对照组各 2 名。每位参与者发生了一个压力性损伤。由于试验的效力不足，这些发现并不能表明干预措施的临床效果。没有参与者脱落或退出，也没有发现或报告任何不良事件、设备缺陷或不良设备影响。我们的研究结果（特别是关于入组、干预措施依从性和安全性的结果）为未来旨在研究如何预防重症监护病房患者压力性损伤的试验提供了一些考虑因素。
