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Abstract：
BACKGROUND: The aim of this study is to assess whether a strategy combining spontaneous breathing trial (SBT) with both pressure support (PS) and positive end-expiratory pressure (PEEP) and extended use of post-extubation non-invasive ventilation (NIV) (extensively-assisted weaning) would shorten the time until successful extubation as compared with SBT with T-piece (TP) and post-extubation NIV performed in selected patients as advocated by guidelines (standard weaning), in difficult-to-wean patients from mechanical ventilation.
METHODS: The study is a single-center prospective open label, randomized controlled superiority trial with two parallel groups and balanced randomization with a 1:1 ratio. Eligible patients were intubated patients mechanically ventilated for more than 24 h who failed their first SBT using TP. In the extensively-assisted weaning group, SBT was performed with PS (7 cmH2O) and PEEP (5 cmH2O). In case of SBT success, an additional SBT with TP was performed. Failure of this SBT-TP was an additional criterion for post-extubation NIV in this group in addition to other recommended criteria. In the standard weaning group, SBT was performed with TP, and NIV was performed according to international guidelines. The primary outcome criterion was the time between inclusion and successful extubation evaluated with a Cox model with adjustment on randomization strata.
RESULTS: From May 2019 to March 2023, 98 patients were included and randomized in the study (49 in each group). Four patients were excluded from the intention-to-treat population (2 in both groups); therefore, 47 patients were analyzed in each group. The extensively-assisted weaning group had a higher median age (68 [58-73] vs. 62 [55-71] yrs.) and similar sex ratio (62% male vs. 57%). Time until successful extubation was not significantly different between extensively-assisted and standard weaning groups (median, 172 [50-436] vs. 95 [47-232] hours, Cox hazard ratio for successful extubation, 0.88 [95% confidence interval: 0.55-1.42] using the standard weaning group as a reference; p = 0.60). All secondary outcomes were not significantly different between groups.
CONCLUSIONS: An extensively-assisted weaning strategy did not lead to a shorter time to successful extubation than a standard weaning strategy. Trial registration The trial was registered on ClinicalTrials.gov (NCT03861117), on March 1, 2019, before the inclusion of the first patient. https://clinicaltrials.gov/study/NCT03861117 .
METHODS: The study is a single-center prospective open label, randomized controlled superiority trial with two parallel groups and balanced randomization with a 1:1 ratio. Eligible patients were intubated patients mechanically ventilated for more than 24 h who failed their first SBT using TP. In the extensively-assisted weaning group, SBT was performed with PS (7 cmH2O) and PEEP (5 cmH2O). In case of SBT success, an additional SBT with TP was performed. Failure of this SBT-TP was an additional criterion for post-extubation NIV in this group in addition to other recommended criteria. In the standard weaning group, SBT was performed with TP, and NIV was performed according to international guidelines. The primary outcome criterion was the time between inclusion and successful extubation evaluated with a Cox model with adjustment on randomization strata.
RESULTS: From May 2019 to March 2023, 98 patients were included and randomized in the study (49 in each group). Four patients were excluded from the intention-to-treat population (2 in both groups); therefore, 47 patients were analyzed in each group. The extensively-assisted weaning group had a higher median age (68 [58-73] vs. 62 [55-71] yrs.) and similar sex ratio (62% male vs. 57%). Time until successful extubation was not significantly different between extensively-assisted and standard weaning groups (median, 172 [50-436] vs. 95 [47-232] hours, Cox hazard ratio for successful extubation, 0.88 [95% confidence interval: 0.55-1.42] using the standard weaning group as a reference; p = 0.60). All secondary outcomes were not significantly different between groups.
CONCLUSIONS: An extensively-assisted weaning strategy did not lead to a shorter time to successful extubation than a standard weaning strategy. Trial registration The trial was registered on ClinicalTrials.gov (NCT03861117), on March 1, 2019, before the inclusion of the first patient. https://clinicaltrials.gov/study/NCT03861117 .
摘要：
背景：这项研究的目的是评估将自主呼吸试验（SBT）与压力支持（PS）和呼气末正压（PEEP）以及延长使用拔管后无创通气（NIV）（广泛辅助断奶）的策略是否会缩短成功拔管的时间，与采用T-piece（TP）和拔管后NIV的SBT相比，在选定的患者中提倡的标准断奶标准（难以从机械通气中断奶的患者。
方法：该研究是单中心前瞻性开放标签，随机对照优势试验，包括两个平行组和1:1比例的平衡随机化。符合条件的患者是机械通气超过24小时的插管患者，这些患者使用TP首次SBT失败。在广泛辅助断奶组中，用PS(7cmH2O)和PEEP(5cmH2O)进行SBT。如果SBT成功，使用TP进行额外的SBT。除其他推荐标准外，该SBT-TP的失败是该组中拔管后NIV的附加标准。在标准断奶组中，用TP进行SBT，根据国际指南进行NIV。主要结果标准是纳入和成功拔管之间的时间，使用Cox模型对随机分层进行调整评估。
结果：从2019年5月至2023年3月，98例患者被纳入研究并随机分组（每组49例）。4名患者被排除在意向治疗人群之外（两组均为2名）；因此，对每组47例患者进行分析。广泛辅助断奶组的中位年龄较高（68[58-73]vs.62[55-71]年。)和相似的性别比例(62%的男性与57%）。在广泛辅助和标准断奶组之间，直到成功拔管的时间没有显着差异（中位数，172[50-436]vs.95[47-232]小时，成功拔管的Cox危险比，0.88[95%置信区间：0.55-1.42]，以标准断奶组为参考；p=0.60）。所有次要结果在组间没有显著差异。
结论：与标准断奶策略相比，广泛辅助断奶策略并没有导致更短的成功拔管时间。试验注册该试验已在ClinicalTrials.gov（NCT03861117）上注册，2019年3月1日，在纳入首例患者之前。https://clinicaltrials.gov/study/NCT03861117.
方法：该研究是单中心前瞻性开放标签，随机对照优势试验，包括两个平行组和1:1比例的平衡随机化。符合条件的患者是机械通气超过24小时的插管患者，这些患者使用TP首次SBT失败。在广泛辅助断奶组中，用PS(7cmH2O)和PEEP(5cmH2O)进行SBT。如果SBT成功，使用TP进行额外的SBT。除其他推荐标准外，该SBT-TP的失败是该组中拔管后NIV的附加标准。在标准断奶组中，用TP进行SBT，根据国际指南进行NIV。主要结果标准是纳入和成功拔管之间的时间，使用Cox模型对随机分层进行调整评估。
结果：从2019年5月至2023年3月，98例患者被纳入研究并随机分组（每组49例）。4名患者被排除在意向治疗人群之外（两组均为2名）；因此，对每组47例患者进行分析。广泛辅助断奶组的中位年龄较高（68[58-73]vs.62[55-71]年。)和相似的性别比例(62%的男性与57%）。在广泛辅助和标准断奶组之间，直到成功拔管的时间没有显着差异（中位数，172[50-436]vs.95[47-232]小时，成功拔管的Cox危险比，0.88[95%置信区间：0.55-1.42]，以标准断奶组为参考；p=0.60）。所有次要结果在组间没有显著差异。
结论：与标准断奶策略相比，广泛辅助断奶策略并没有导致更短的成功拔管时间。试验注册该试验已在ClinicalTrials.gov（NCT03861117）上注册，2019年3月1日，在纳入首例患者之前。https://clinicaltrials.gov/study/NCT03861117.
