학술논문

Sigh Ventilation in Patients With Trauma: The SiVent Randomized Clinical Trial.
Document Type
Article
Source
JAMA: Journal of the American Medical Association. 11/28/2023, Vol. 330 Issue 20, p1982-1990. 9p.
Subject
*ARTIFICIAL respiration
*TRAUMA centers
*ADULT respiratory distress syndrome
*VENTILATION
*CLINICAL trials
*DISEASE risk factors
Language
ISSN
0098-7484
Abstract
Key Points: Question: Does adding sigh breaths to the usual care of trauma patients receiving mechanical ventilation increase ventilator-free days? Findings: In this randomized clinical trial among 524 trauma patients with risk factors for developing acute respiratory distress syndrome, the addition of sigh breaths did not significantly increase ventilator-free days compared with usual care alone (median ventilator-free days, 18.4 vs 16.1, respectively). Although not adjusted for multiple testing, sigh breaths were associated with improvement in secondary outcomes including all-cause mortality. There was no evidence of harm. Meaning: Sigh breaths added to usual care did not significantly increase ventilator-free days among trauma patients who received mechanical ventilation but may improve clinical outcomes. Importance: Among patients receiving mechanical ventilation, tidal volumes with each breath are often constant or similar. This may lead to ventilator-induced lung injury by altering or depleting surfactant. The role of sigh breaths in reducing ventilator-induced lung injury among trauma patients at risk of poor outcomes is unknown. Objective: To determine whether adding sigh breaths improves clinical outcomes. Design, Setting, and Participants: A pragmatic, randomized trial of sigh breaths plus usual care conducted from 2016 to 2022 with 28-day follow-up in 15 academic trauma centers in the US. Inclusion criteria were age older than 18 years, mechanical ventilation because of trauma for less than 24 hours, 1 or more of 5 risk factors for developing acute respiratory distress syndrome, expected duration of ventilation longer than 24 hours, and predicted survival longer than 48 hours. Interventions: Sigh volumes producing plateau pressures of 35 cm H2O (or 40 cm H2O for inpatients with body mass indexes >35) delivered once every 6 minutes. Usual care was defined as the patient's physician(s) treating the patient as they wished. Main Outcomes and Measures: The primary outcome was ventilator-free days. Prespecified secondary outcomes included all-cause 28-day mortality. Results: Of 5753 patients screened, 524 were enrolled (mean [SD] age, 43.9 [19.2] years; 394 [75.2%] were male). The median ventilator-free days was 18.4 (IQR, 7.0-25.2) in patients randomized to sighs and 16.1 (IQR, 1.1-24.4) in those receiving usual care alone (P =.08). The unadjusted mean difference in ventilator-free days between groups was 1.9 days (95% CI, 0.1 to 3.6) and the prespecified adjusted mean difference was 1.4 days (95% CI, −0.2 to 3.0). For the prespecified secondary outcome, patients randomized to sighs had 28-day mortality of 11.6% (30/259) vs 17.6% (46/261) in those receiving usual care (P =.05). No differences were observed in nonfatal adverse events comparing patients with sighs (80/259 [30.9%]) vs those without (80/261 [30.7%]). Conclusions and Relevance: In a pragmatic, randomized trial among trauma patients receiving mechanical ventilation with risk factors for developing acute respiratory distress syndrome, the addition of sigh breaths did not significantly increase ventilator-free days. Prespecified secondary outcome data suggest that sighs are well-tolerated and may improve clinical outcomes. Trial Registration: ClinicalTrials.gov Identifier: NCT02582957 This randomized clinical trial compares the efficacy of sighs in addition to usual care vs usual care alone in improving clinical outcomes among trauma patients receiving mechanical ventilation and are at risk for developing acute respiratory distress syndrome. [ABSTRACT FROM AUTHOR]