Wearable device for prevention of postoperative and post-discharge hypoxemia: A randomized pilot trial.
Wearable device for prevention of postoperative and post-discharge hypoxemia: A randomized pilot trial.
复制标题
用于预防术后和出院后低氧血症的可穿戴设备：一项随机试点试验。
DOI：
10.1111/aas.14193
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发表时间：
2023
影响因子：
2.1
通讯作者：
Sessler,DanielI
中科院分区：
文献类型：
--
作者：
Li,Kai;Saab,Remie;Bravo,Mauro;Mascha,EdwardJ;Han,Yanyan;Nault,Rod;Olson,Lloyd;Sessler,DanielI
Oxalert增强型脉搏血氧仪（EPO）是一种可穿戴设备，可检测并提醒患者低氧血症。在一项预先计划的试点试验中，我们估计了带患者警报的连续饱和度监测对院内和出院后饱和度的影响；我们进一步评估了干预的可行性。方法将非心脏手术患者随机分为有患者警示的Oxalert组（Monitor + Alert组，N= 25）和无患者警示的Oxalert组（Monitor + Alert组，N= 24）。住院期间持续监测长达6天，出院后持续监测24小时。采用Wilcoxon秩和检验比较各组患者住院和出院后SpO2<90%（%）和SpO2<90% （% * min）的时间加权平均（TWA）和面积，使用位置移位的hogees - lehmann估计量估计治疗效果中位数差和95%置信区间（CI）。结果每周入组≥2例患者，共有49例患者获得记录，中位数[四分位数]为91%[85,95]%的住院时间。在医院中，监测+警报组TWA SpO2<90%的中位数[四分位数]为0.11[0.03,0.25]%，仅监测组为0.29[0.04,0.71]%，估计中位数差异（95% CI）为- 0.1 (- 0.4,0)%,p= 0.120。在医院，监测+警报组SpO2<90%的曲线下面积（AUC）中位数为635 [204,1513]% * min，仅监测组为1260 [117,5278]% * min，估计中位数差异（95% CI）为- 407 (- 1816,208)% * min,p= .349。出院后，估计中位差异（95% CI）仅为- 0.1 (- 0.2,0)%,p= .307。结论两组患者对Oxalert系统耐受性良好，入组率高。随机分配到活跃Oxalert系统的患者在住院期间经历了一半的术后去饱和事件，尽管在这个小型试点试验中差异没有统计学意义。相比之下，Oxalert系统并没有降低放电后的去饱和。在外科病人到达普通医院病房后，甚至在他们出院回家后，发现手术后的恶化情况，可能有助于必要的“抢救”干预。评估生命体征（包括氧合）的可穿戴设备是一种实际需求。在这项初步研究中，测试了一种可穿戴式脉搏血氧仪（带和不带低氧血症警报器）在术后病例中（包括在家中）信号采集的可行性和可接受性。结果表明，在术后后期可能出现缺氧的情况下，有必要进行全面的试验来测试这种“可穿戴”设备可能的临床益处。该试验已在ClincialTrial.gov注册（NCT04453722）。
BackgroundThe Oxalert Enhanced Pulse Oximeter (EPO) is a wearable device that detects and alerts patients to hypoxemia. In a preplanned pilot trial, we estimated the effect of continuous saturation monitoring with patient alerts on in‐hospital and post‐discharge saturation; we further assessed the feasibility of the intervention.MethodsNoncardiac surgical patients were randomized to either the Oxalert with patient alerts (Monitor + Alert,N= 25) or the Oxalert without patient alerts (Monitor Only,N= 24). Monitoring continued during hospitalization for up to 6 days and for 24 h after hospital discharge. Patients in each group were compared on time‐weighted average (TWA) SpO2<90% (%) and area under SpO2<90% (% * min) in‐hospital and after discharge using the Wilcoxon rank sum test, with the treatment effect median difference and 95% confidence interval (CI) estimated using the Hodges–Lehmann estimator of location shift.ResultsWe enrolled ≥2 patients per week, for a total of 49 patients in whom recording were obtained for a median [quartiles] of 91 [85, 95]% of the time in hospital. In‐hospital, TWA SpO2<90% was a median [quartiles] of 0.11 [0.03, 0.25]% for Monitor + Alert and 0.29 [0.04, 0.71]% for Monitor‐Only patients, with estimated median difference (95% CI) of −0.1 (−0.4, 0)%,p= .120. In hospital, the area under the curve (AUC) SpO2<90% was a median [quartiles] of 635 [204, 1513] % * min for Monitor + Alert and 1260 [117, 5278] % * min for Monitor‐Only patients, with estimated median difference (95% CI) of −407 (−1816, 208) % * min,p= .349. Post‐discharge, the estimated median difference (95% CI) was only −0.1 (−0.2, 0) %,p= .307.ConclusionsThe Oxalert system was well tolerated in both groups and enrollment was strong. Patients randomized to active Oxalert systems experienced half as many postoperative desaturation events while hospitalized, although the difference was not statistically significant in this small pilot trial. In contrast, the Oxalert system did not reduce post‐discharge desaturation. Detecting postoperative deterioation in surgical patients after they arrive on regular hospital wards, and even after they have been discharged home, can potentially facilitate necessary “rescue” interventions. Wearable devices assessing vital signs, including oxygenation, are a practical requirement. In this pilot study, a wearable pulse oximeter, with and without hypoxemia alarms, was tested for feasibility and acceptability for signal collection in postoperative cases, including at home. Results indicate that a full‐scale trial is warranted to test for possible clinical benefit with this type of “wearable” where late postoperative hypoxia could be a concern. The trial was registered at ClincialTrial.gov (NCT04453722).