基于风险分层的早期预警干预对全麻术后苏醒期低氧血症发生率及复苏质量的影响：一项前瞻性随机对照研究-现代医学

基于风险分层的早期预警干预对全麻术后苏醒期低氧血症发生率及复苏质量的影响：一项前瞻性随机对照研究

单位：南京医科大学第一附属医院麻醉与围术期医学科, 江苏南京 210000

分类号：R614.2;R473.6

出版年·卷·期（页码）：2026·54·第六期（993-1001）

摘要：

目的：评估基于经验性风险分层的早期预警干预策略对全麻术后苏醒期低氧血症发生率及复苏相关结局的影响。方法：本研究为单中心、前瞻性、随机对照优效性试验。连续入组2024年6月至2025年6月期间在本院接受择期全身麻醉上腹部或胸科手术并计划转入麻醉后复苏室(PACU)的成年患者，按1:1随机分配至对照组和干预组。对照组接受PACU常规护理；干预组依据经验性风险评分进行低危、中危和高危分层，并实施相应的早期预警干预。主要结局为苏醒期低氧血症发生率，定义为入PACU至出PACU前SpO₂<90%持续≥15 s。次要结局包括最低SpO₂、PACU再次插管率、PACU停留时间、不良事件及护士满意度。主要结局采用意向性治疗(ITT) 分析, 相对风险(RR)及95%置信区间采用Log-binomial回归或Poisson回归(稳健标准误)估计。结果：在ITT分析人群中(n=462)，干预组低氧血症发生率低于对照组，差异有统计学意义(P<0.001)。绝对风险降低12.5%，需治疗人数(NNT)为8(95%CI 5~17)。干预组最低SpO₂更高，PACU停留时间更短，差异有统计学意义(均P<0.001)。干预组的再次插管率较低(RR=0.21，95%CI 0.05~0.90)，差异有统计学意义(Fisher精确检验P=0.036)，但由于事件数较少(2 vs. 10)，结果需谨慎解释。2组恶心呕吐和躁动发生率比较，差异无统计学意义(均P>0.05)。探索性亚组分析显示，高危患者中效应量较大，但交互作用检验差异无统计学意义(P>0.05)。结论：基于经验性风险分层的早期预警干预策略可降低PACU低氧血症发生率及多项苏醒质量相关指标，且未观察到不良事件增加的证据。该策略在PACU中具有潜在临床应用价值，但其普适性及风险分层工具的可迁移性仍需多中心研究进一步验证。

Objective: To evaluate the effect of an early warning intervention strategy based on empirical risk stratification on the incidence of emergence hypoxemia in the post-anesthesia care unit(PACU) and on recovery-related outcomes following general anesthesia. Methods: This was a single-center, prospective, randomized controlled superiority trial. Adult patients who underwent elective upper abdominal or thoracic surgery under general anesthesia and were scheduled for PACU admission between June 2024 and June 2025 were consecutively enrolled and randomly assigned in a 1:1 ratio to either the control group or the intervention group. The control group received routine PACU care; the intervention group was stratified into low-, intermediate-, and high-risk categories according to an empirical risk score and received corresponding early warning interventions. The primary outcome was the incidence of hypoxemia during emergence and recovery, defined as any episode of SpO₂ <90% lasting ≥15 s from PACU admission until discharge. Secondary outcomes included the lowest SpO₂, the rate of reintubation in the PACU, PACU length of stay, adverse events, and nurse satisfaction. The primary outcome was analyzed in the intention-to-treat(ITT) population, with relative risk(RR) and 95% confidence interval(CI) estimated using log-binomial regression or Poisson regression with robust standard errors. Results: In the ITT population(n=462), the incidence of hypoxemia was significantly lower in the intervention group than in the control group(P<0.001). The absolute risk reduction was 12.5%, yielding a number needed to treat(NNT) of 8(95%CI 5-17). The lowest SpO₂ was significantly higher and PACU length of stay was significantly shorter in the intervention group(all P<0.001). The reintubation rate was lower in the intervention group(RR=0.21, 95%CI 0.05-0.90; Fisher's exact test P=0.036), although this result should be interpreted cautiously because of the small number of events(2 vs. 10). The incidences of nausea/vomiting and agitation did not differ significantly between groups(all P>0.05). Exploratory subgroup analysis suggested a larger effect in high-risk patients, but the interaction test was not statistically significant(P>0.05). Conclusion: An early warning intervention strategy based on empirical risk stratification can reduce the incidence of hypoxemia in the PACU and improve several indicators of recovery quality without evidence of increased adverse events. This strategy has potential clinical value in the PACU setting, but its generalizability and the transportability of the risk stratification tool require further validation in multicenter studies.

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