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筛查频率与自主呼吸试验技术:一项随机临床试验。

Frequency of Screening and Spontaneous Breathing Trial Techniques: A Randomized Clinical Trial.

作者信息

Burns Karen E A, Wong Jessica, Rizvi Leena, Lafreniere-Roula Myriam, Thorpe Kevin, Devlin John W, Cook Deborah J, Seely Andrew, Dodek Peter M, Tanios Maged, Piraino Thomas, Gouskos Audrey, Kiedrowski Kenneth C, Kay Phyllis, Mitchell Susan, Merner George W, Mayette Michael, D'Aragon Frederick, Lamontagne Francois, Rochwerg Bram, Turgeon Alexis, Sia Ying Tung, Charbonney Emmanuel, Aslanian Pierre, Criner Gerard J, Hyzy Robert C, Beitler Jeremy R, Kassis Elias Baedorf, Kutsogiannis Demetrios James, Meade Maureen O, Liebler Janice, Iyer-Kumar Santhi, Tsang Jennifer, Cirone Robert, Shanholtz Carl, Hill Nicholas S

机构信息

Interdepartmental Division of Critical Care, University of Toronto, Toronto, Ontario, Canada.

Department of Critical Care, Unity Health Toronto-St Michael's Hospital, Toronto, Ontario, Canada.

出版信息

JAMA. 2024 Dec 3;332(21):1808-1821. doi: 10.1001/jama.2024.20631.

Abstract

IMPORTANCE

The optimal screening frequency and spontaneous breathing trial (SBT) technique to liberate adults from ventilators are unknown.

OBJECTIVE

To compare the effects of screening frequency (once-daily screening vs more frequent screening) and SBT technique (pressure-supported SBT with a pressure support level that was >0-≤8 cm H2O and a positive end-expiratory pressure [PEEP] level that was >0-≤5 cm H2O vs T-piece SBT) on the time to successful extubation.

DESIGN, SETTING, AND PARTICIPANTS: Randomized clinical trial with a 2 × 2 factorial design including critically ill adults who were receiving invasive mechanical ventilation for at least 24 hours, who were capable of initiating spontaneous breaths or triggering ventilators, and who were receiving a fractional concentration of inspired oxygen that was 70% or less and a PEEP level of 12 cm H2O or less. Recruitment was between January 2018 and February 2022 at 23 intensive care units in North America; last follow-up occurred October 18, 2022.

INTERVENTIONS

Participants were enrolled early to enable protocolized screening (more frequent vs once daily) to identify the earliest that patients met criteria to undergo pressure-supported or T-piece SBT lasting 30 to 120 minutes.

MAIN OUTCOME AND MEASURES

Time to successful extubation (time when unsupported, spontaneous breathing began and was sustained for ≥48 hours after extubation).

RESULTS

Of 797 patients (198 in the once-daily screening and pressure-supported SBT group, 204 in once-daily screening and T-piece SBT, 195 in more frequent screening and pressure-supported SBT, and 200 in more frequent screening and T-piece SBT), the mean age was 62.4 (SD, 18.4) years and 472 (59.2%) were men. There were no statistically significant differences by screening frequency (hazard ratio [HR], 0.88 [95% CI, 0.76-1.03]; P = .12) or by SBT technique (HR, 1.06 [95% CI, 0.91-1.23]; P = .45). The median time to successful extubation was 2.0 days (95% CI, 1.7-2.7) for once-daily screening and pressure-supported SBT, 3.1 days (95% CI, 2.7-4.8) for once-daily screening and T-piece SBT, 3.9 days (95% CI, 2.9-4.7) for more frequent screening and pressure-supported SBT, and 2.9 days (95% CI, 2.0-3.1) for more frequent screening and T-piece SBT. An unexpected interaction between screening frequency and SBT technique required pairwise contrasts that revealed more frequent screening (vs once-daily screening) and pressure-supported SBT increased the time to successful extubation (HR, 0.70 [95% CI, 0.50-0.96]; P = .02). Once-daily screening and pressure-supported SBT (vs T-piece SBT) did not reduce the time to successful extubation (HR, 1.30 [95% CI, 0.98-1.70]; P = .08).

CONCLUSIONS AND RELEVANCE

Among critically ill adults who received invasive mechanical ventilation for more than 24 hours, screening frequency (once-daily vs more frequent screening) and SBT technique (pressure-supported vs T-piece SBT) did not change the time to successful extubation. However, an unexpected and statistically significant interaction was identified; protocolized more frequent screening combined with pressure-supported SBTs increased the time to first successful extubation.

TRIAL REGISTRATION

ClinicalTrials.gov Identifiers: NCT02399267 and NCT02969226.

摘要

重要性

使成人脱离呼吸机的最佳筛查频率和自主呼吸试验(SBT)技术尚不清楚。

目的

比较筛查频率(每日一次筛查与更频繁筛查)和SBT技术(压力支持水平>0至≤8 cm H₂O且呼气末正压[PEEP]水平>0至≤5 cm H₂O的压力支持SBT与T管SBT)对成功拔管时间的影响。

设计、设置和参与者:采用2×2析因设计的随机临床试验,纳入接受有创机械通气至少24小时、能够自主呼吸或触发呼吸机、吸入氧分数≤70%且PEEP水平≤12 cm H₂O的危重症成人。于2018年1月至2022年2月在北美的23个重症监护病房招募;最后一次随访于2022年10月18日进行。

干预措施

尽早纳入参与者,以便进行标准化筛查(更频繁与每日一次),以确定患者最早符合接受持续30至120分钟的压力支持或T管SBT的标准。

主要结局和测量指标

成功拔管时间(拔管后无支持的自主呼吸开始并持续≥48小时的时间)。

结果

797例患者(每日一次筛查和压力支持SBT组198例,每日一次筛查和T管SBT组204例,更频繁筛查和压力支持SBT组195例,更频繁筛查和T管SBT组200例),平均年龄62.4(标准差,18.4)岁,472例(59.2%)为男性。筛查频率(风险比[HR],0.88[95%CI,0.76 - 1.03];P = 0.12)或SBT技术(HR,1.06[95%CI,0.91 - 1.23];P = 0.45)方面无统计学显著差异。每日一次筛查和压力支持SBT的成功拔管中位时间为2.0天(95%CI,1.7 - 2.7),每日一次筛查和T管SBT为3.1天(95%CI,2.7 - 4.8),更频繁筛查和压力支持SBT为3.9天(95%CI,2.9 - 4.7),更频繁筛查和T管SBT为2.9天(95%CI,2.0 - 3.1)。筛查频率和SBT技术之间存在意外的交互作用,需要进行成对对比,结果显示更频繁筛查(与每日一次筛查相比)和压力支持SBT增加了成功拔管时间(HR,0.70[95%CI,0.50 - 0.96];P = 0.02)。每日一次筛查和压力支持SBT(与T管SBT相比)并未缩短成功拔管时间(HR,1.30[95%CI,0.98 - 1.70];P = 0.08)。

结论与相关性

在接受有创机械通气超过24小时的危重症成人中,筛查频率(每日一次与更频繁筛查)和SBT技术(压力支持与T管SBT)并未改变成功拔管时间。然而,发现了一个意外且具有统计学意义的交互作用;标准化的更频繁筛查联合压力支持SBT增加了首次成功拔管的时间。

试验注册

ClinicalTrials.gov标识符:NCT02399267和NCT02969226。

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