Hui Ye, Li-Hua Chu, Guo-Hao Xie, Ye-Jing Hua, Yi Lou, Qiao-Hong Wang, Zhi-Xin Xu, Meng-Yan Tang, Bing-Duo Wang, Hui-Yi Hu, Jing Ying, Tian Yu, Hai-Ying Wang, Yuan Wang, Zhi-Jian Ye, Xiao-Fang Bao, Ming-Cang Wang, Ling-Yang Chen, Xiao-Xia Wang, Xing-Bo Zhang, Chang-Shun Huang, Jun Wang, Ya-Ping Lu, Fo-Quan Luo, Wang Zhou, Chuan-Guang Wang, Hao Cheng, Wen-Jie Liu, Jie Luo, Yan-Qin Wu, Ru-Ru Li, Dong Wang, Ling-Qian Hou, Lu Shi, Jun Zhang, Kun Wang, Xin Pi, Rong Zhou, Qin-Qin Yang, Pei-Ling Wan, Hui Li, Shui-Jing Wu, Sheng-Wen Song, Ping Cui, Liqi Shu, Nazrul Islam, Xiang-Ming Fang
{"title":"侧位与仰卧位对镇静成人低氧血症的影响:多中心随机对照试验。","authors":"Hui Ye, Li-Hua Chu, Guo-Hao Xie, Ye-Jing Hua, Yi Lou, Qiao-Hong Wang, Zhi-Xin Xu, Meng-Yan Tang, Bing-Duo Wang, Hui-Yi Hu, Jing Ying, Tian Yu, Hai-Ying Wang, Yuan Wang, Zhi-Jian Ye, Xiao-Fang Bao, Ming-Cang Wang, Ling-Yang Chen, Xiao-Xia Wang, Xing-Bo Zhang, Chang-Shun Huang, Jun Wang, Ya-Ping Lu, Fo-Quan Luo, Wang Zhou, Chuan-Guang Wang, Hao Cheng, Wen-Jie Liu, Jie Luo, Yan-Qin Wu, Ru-Ru Li, Dong Wang, Ling-Qian Hou, Lu Shi, Jun Zhang, Kun Wang, Xin Pi, Rong Zhou, Qin-Qin Yang, Pei-Ling Wan, Hui Li, Shui-Jing Wu, Sheng-Wen Song, Ping Cui, Liqi Shu, Nazrul Islam, Xiang-Ming Fang","doi":"10.1136/bmj-2025-084539","DOIUrl":null,"url":null,"abstract":"<p><strong>Objectives: </strong>To evaluate the effect of lateral versus supine positioning on incidence of hypoxaemia in sedated patients and to provide evidence based recommendations for respiratory strategies.</p><p><strong>Design: </strong>Prospective, multicentre, randomised controlled trial.</p><p><strong>Setting: </strong>14 tertiary hospitals in China, July to November 2024.</p><p><strong>Participants: </strong>2159 adults (≥18 years) who underwent sedation.</p><p><strong>Interventions: </strong>Sedated patients were randomly assigned (1:1) to receive either lateral positioning or conventional supine positioning, stratified by study centres.</p><p><strong>Main outcome measures: </strong>The primary outcome was incidence of hypoxaemia (peripheral oxygen saturation (SpO<sub>2</sub>) ≤90%) within the first 10 minutes after positioning. Secondary outcomes included airway rescue interventions, incidence of severe hypoxaemia (SpO<sub>2</sub> ≤85%), lowest oxygen saturation recorded, length of stay in the post-anaesthesia care unit, and safety measures (eg, bradycardia, tachycardia, hypotension, new onset arrhythmia). Analyses were performed on an intention-to-treat basis.</p><p><strong>Results: </strong>Of 2159 patients randomised, 2143 were included in the primary analysis. The mean age of the patients was 53.1 years, mean body mass index was 23.9, and 53.7% (1150/2143) were women. The incidence of hypoxaemia was significantly lower in the lateral group compared with supine group (5.4% (58/1073) <i>v</i> 15.0% (161/1070); adjusted risk ratio 0.36, 95% confidence interval (CI) 0.27 to 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) <i>v</i> 13.8% (148/1070); adjusted risk ratio 0.46, 0.34 to 0.61; P<0.001), had a lower incidence of severe hypoxaemia (0.7% (8/1073) <i>v</i> 4.8% (51/1070); adjusted risk ratio 0.16, 0.07 to 0.33; P<0.001), and had a higher mean lowest SpO<sub>2</sub> level (96.9% <i>v</i> 95.7%, absolute adjusted mean difference 1.20%, 95% CI 0.87% to 1.54%; P<0.001). Additionally, length of stay in the post-anaesthesia care unit was shorter in the lateral group (38.2 <i>v</i> 40.5 minutes; absolute adjusted mean difference -2.22 minutes; 95% CI -3.63 to -0.80; P=0.002). Safety outcomes were comparable between the groups, but tachycardia was less frequent in the lateral group.</p><p><strong>Conclusions: </strong>Placing sedated adults in the lateral position significantly reduces the incidence and severity of hypoxaemia and decreases the need for airway rescue interventions without compromising safety. Given its simplicity and low cost, lateral positioning could offer advantages in remote or resource constrained clinical settings. Further replication studies targeting patients with advanced age and high body mass index are needed to improve the generalisability of the findings.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT06459167.</p>","PeriodicalId":9201,"journal":{"name":"BMJ : British Medical Journal","volume":"390 ","pages":"e084539"},"PeriodicalIF":42.7000,"publicationDate":"2025-08-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12362200/pdf/","citationCount":"0","resultStr":"{\"title\":\"Effect of lateral versus supine positioning on hypoxaemia in sedated adults: multicentre randomised controlled trial.\",\"authors\":\"Hui Ye, Li-Hua Chu, Guo-Hao Xie, Ye-Jing Hua, Yi Lou, Qiao-Hong Wang, Zhi-Xin Xu, Meng-Yan Tang, Bing-Duo Wang, Hui-Yi Hu, Jing Ying, Tian Yu, Hai-Ying Wang, Yuan Wang, Zhi-Jian Ye, Xiao-Fang Bao, Ming-Cang Wang, Ling-Yang Chen, Xiao-Xia Wang, Xing-Bo Zhang, Chang-Shun Huang, Jun Wang, Ya-Ping Lu, Fo-Quan Luo, Wang Zhou, Chuan-Guang Wang, Hao Cheng, Wen-Jie Liu, Jie Luo, Yan-Qin Wu, Ru-Ru Li, Dong Wang, Ling-Qian Hou, Lu Shi, Jun Zhang, Kun Wang, Xin Pi, Rong Zhou, Qin-Qin Yang, Pei-Ling Wan, Hui Li, Shui-Jing Wu, Sheng-Wen Song, Ping Cui, Liqi Shu, Nazrul Islam, Xiang-Ming Fang\",\"doi\":\"10.1136/bmj-2025-084539\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Objectives: </strong>To evaluate the effect of lateral versus supine positioning on incidence of hypoxaemia in sedated patients and to provide evidence based recommendations for respiratory strategies.</p><p><strong>Design: </strong>Prospective, multicentre, randomised controlled trial.</p><p><strong>Setting: </strong>14 tertiary hospitals in China, July to November 2024.</p><p><strong>Participants: </strong>2159 adults (≥18 years) who underwent sedation.</p><p><strong>Interventions: </strong>Sedated patients were randomly assigned (1:1) to receive either lateral positioning or conventional supine positioning, stratified by study centres.</p><p><strong>Main outcome measures: </strong>The primary outcome was incidence of hypoxaemia (peripheral oxygen saturation (SpO<sub>2</sub>) ≤90%) within the first 10 minutes after positioning. Secondary outcomes included airway rescue interventions, incidence of severe hypoxaemia (SpO<sub>2</sub> ≤85%), lowest oxygen saturation recorded, length of stay in the post-anaesthesia care unit, and safety measures (eg, bradycardia, tachycardia, hypotension, new onset arrhythmia). Analyses were performed on an intention-to-treat basis.</p><p><strong>Results: </strong>Of 2159 patients randomised, 2143 were included in the primary analysis. The mean age of the patients was 53.1 years, mean body mass index was 23.9, and 53.7% (1150/2143) were women. The incidence of hypoxaemia was significantly lower in the lateral group compared with supine group (5.4% (58/1073) <i>v</i> 15.0% (161/1070); adjusted risk ratio 0.36, 95% confidence interval (CI) 0.27 to 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) <i>v</i> 13.8% (148/1070); adjusted risk ratio 0.46, 0.34 to 0.61; P<0.001), had a lower incidence of severe hypoxaemia (0.7% (8/1073) <i>v</i> 4.8% (51/1070); adjusted risk ratio 0.16, 0.07 to 0.33; P<0.001), and had a higher mean lowest SpO<sub>2</sub> level (96.9% <i>v</i> 95.7%, absolute adjusted mean difference 1.20%, 95% CI 0.87% to 1.54%; P<0.001). Additionally, length of stay in the post-anaesthesia care unit was shorter in the lateral group (38.2 <i>v</i> 40.5 minutes; absolute adjusted mean difference -2.22 minutes; 95% CI -3.63 to -0.80; P=0.002). 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引用次数: 0
摘要
目的:评估侧位与仰卧位对镇静患者低氧血症发生率的影响,并为呼吸策略提供基于证据的建议。设计:前瞻性、多中心、随机对照试验。研究对象:全国14家三级医院,2024年7月至11月。参与者:2159名接受镇静治疗的成年人(≥18岁)。干预措施:镇静患者被随机分配(1:1)接受侧卧位或传统仰卧位,按研究中心分层。主要观察指标:主要观察指标为体位后10分钟内低氧血症发生率(外周血氧饱和度(SpO2)≤90%)。次要结局包括气道抢救干预、严重低氧血症(SpO2≤85%)发生率、记录的最低血氧饱和度、麻醉后护理单元的住院时间和安全措施(如心动过缓、心动过速、低血压、新发心律失常)。在意向治疗基础上进行分析。结果:在随机分组的2159例患者中,2143例纳入了初步分析。患者平均年龄53.1岁,平均体重指数23.9,女性占53.7%(1150/2143)。侧卧组低氧血症发生率明显低于仰卧组(5.4% (58/1073)vs 15.0% (161/1070);调整后风险比0.36,95%可信区间(CI) 0.27 ~ 0.49;Pv 13.8% (148/1070);调整后风险比0.46,0.34 ~ 0.61;Pv为4.8% (51/1070);调整后风险比0.16,0.07 ~ 0.33;P2水平(96.9% v 95.7%,绝对校正平均差1.20%,95% CI 0.87% ~ 1.54%; Pv 40.5分钟;绝对校正平均差-2.22分钟;95% CI -3.63 ~ -0.80; P=0.002)。两组间的安全性结果具有可比性,但侧卧组心动过速发生率较低。结论:将镇静的成人置于侧位可显著降低低氧血症的发生率和严重程度,并在不影响安全性的情况下减少气道抢救干预的需要。由于其简单和低成本,侧卧位可以在偏远或资源有限的临床环境中提供优势。需要针对高龄和高体重指数患者进行进一步的重复性研究,以提高研究结果的普遍性。试验注册:ClinicalTrials.gov NCT06459167。
Effect of lateral versus supine positioning on hypoxaemia in sedated adults: multicentre randomised controlled trial.
Objectives: To evaluate the effect of lateral versus supine positioning on incidence of hypoxaemia in sedated patients and to provide evidence based recommendations for respiratory strategies.
Setting: 14 tertiary hospitals in China, July to November 2024.
Participants: 2159 adults (≥18 years) who underwent sedation.
Interventions: Sedated patients were randomly assigned (1:1) to receive either lateral positioning or conventional supine positioning, stratified by study centres.
Main outcome measures: The primary outcome was incidence of hypoxaemia (peripheral oxygen saturation (SpO2) ≤90%) within the first 10 minutes after positioning. Secondary outcomes included airway rescue interventions, incidence of 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). Analyses were performed on an intention-to-treat basis.
Results: Of 2159 patients randomised, 2143 were included in the primary analysis. The mean age of the patients was 53.1 years, mean body mass index was 23.9, and 53.7% (1150/2143) were women. The incidence of 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). 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 incidence of 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). 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). Safety outcomes were comparable between the groups, but tachycardia was less frequent in the lateral group.
Conclusions: Placing sedated adults in the lateral position significantly reduces the incidence and severity of hypoxaemia and decreases the need for airway rescue interventions without compromising safety. Given its simplicity and low cost, lateral positioning could offer advantages in remote or resource constrained clinical settings. Further replication studies targeting patients with advanced age and high body mass index are needed to improve the generalisability of the findings.
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