Effect of lateral versus supine positioning on hypoxaemia in sedated adults: multicentre randomised controlled trial.

Methods

Prospective, multicentre, randomised controlled trial.

前瞻性、多中心、随机对照试验。

14 tertiary hospitals in China, July to November 2024.

14家中国三级医院，2024年7月至11月。

2159 adults (≥18 years) who underwent sedation.

2159名成年人（≥18岁）接受了镇静治疗。

Sedated patients were randomly assigned (1:1) to receive either lateral positioning or conventional supine positioning, stratified by study centres.

镇静患者被随机分配（1:1）接受侧卧位或常规仰卧位，按研究中心进行分层。

The primary outcome was incidenceof hypoxaemia (peripheral oxygen saturation (SpO2) ≤90%) within the first 10 minutes after positioning.

主要结果是定位后10分钟内低氧血症（外周氧饱和度（SpO2）≤90%）的发生率。

Secondary outcomes included airway rescue interventions, incidenceof severe hypoxaemia (SpO2 ≤85%), lowest oxygen saturation recorded, length of stay in the post-anaesthesia care unit, and safety measures (eg, bradycardia, tachycardia, hypotension, new onset arrhythmia).

次要结果包括气道救援干预、严重低氧血症（SpO2 ≤85%）的发生率、记录的最低氧饱和度、术后麻醉护理单元的住院时间以及安全措施（例如，心动过缓、心动过速、低血压、新发心律失常）等。

Analyses were performed on an intention-to-treatbasis.

分析是基于意向治疗原则进行的。

Results

Of 2159 patients randomised, 2143 were included in the primary analysis.

在随机分组的2159名患者中，有2143名患者被纳入主要分析。

The mean age of the patients was 53.1 years, mean body mass index was 23.9, and 53.7% (1150/2143) were women.

患者的平均年龄为53.1岁，平均体重指数为23.9，53.7%（1150/2143）的患者为女性。

The incidenceof hypoxaemia was significantly lower in the lateral group compared with supine group (5.4% (58/1073) v 15.0% (161/1070); adjusted risk ratio 0.36, 95% confidence interval(CI) 0.27 to 0.49; P<0.001).

与仰卧位组相比，侧卧位组的低氧血症发生率显著降低（5.4% (58/1073) 对比 15.0% (161/1070)；调整后的风险比为0.36，95%置信区间（CI）为0.27至0.49；P<0.001）。

Compared with patients in the supine group, patients in the lateral group required fewer airway rescue interventions (6.3% (68/1073) v 13.8% (148/1070); adjusted risk ratio 0.46, 0.34 to 0.61; P<0.001), had a lower incidenceof severe hypoxaemia (0.7% (8/1073) v 4.8% (51/1070); adjusted risk ratio 0.16, 0.07 to 0.33; P<0.001), and had a higher mean lowest SpO2 level (96.9% v 95.7%, absolute adjusted mean difference 1.20%, 95% CI 0.87% to 1.54%; P<0.001).

与仰卧位组患者相比，侧卧位组患者需要的气道救援干预较少（6.3% (68/1073) 对比 13.8% (148/1070)；调整后的风险比为0.46，95%置信区间为0.34至0.61；P<0.001），严重低氧血症的发生率较低（0.7% (8/1073) 对比 4.8% (51/1070)；调整后的风险比为0.16，95%置信区间为0.07至0.33；P<0.001），并且平均最低SpO2水平较高（96.9% 对比 95.7%，绝对调整后的平均差异为1.20%，95%置信区间为0.87%至1.54%；P<0.001）。

Additionally, length of stay in the post-anaesthesia care unit was shorter in the lateral group (38.2 v 40.5 minutes; absolute adjusted mean difference -2.22 minutes; 95% CI -3.63 to -0.80; P=0.002).

此外，侧卧位组在麻醉恢复室的停留时间较短（38.2分钟对比40.5分钟；绝对调整后平均差异为-2.22分钟；95%置信区间为-3.63至-0.80；P=0.002）。

Safety outcomes were comparable between the groups, but tachycardia was less frequent in the lateral group.

两组的安全结果相当，但侧卧位组心动过速的发生率较低。

Conclusions

Placing sedated adults in the lateral position significantly reduces the incidenceand severity of hypoxaemia and decreases the need for airway rescue interventions without compromising safety.

将镇静的成人置于侧卧位显著降低了低氧血症的发生率和严重程度，并减少了对气道救援干预的需求，同时不损害安全性。

Given its simplicity and low cost, lateral positioning could offer advantages in remote or resource constrained clinical settings.

鉴于其简单性和低成本，侧卧位可能在偏远或资源受限的临床环境中提供优势。

Further replication studies targeting patients with advanced age and high body mass index are needed to improve the generalisability of the findings.

需要进一步的复制研究针对高龄和高体质指数的患者，以提高研究结果的普遍适用性。

trial_registration

ClinicalTrials.gov NCT06459167.

ClinicalTrials.gov NCT06459167。