Protocolized Postextubation Respiratory Support to Prevent Reintubation: A Randomized Clinical Trial

Abstract

Rationale: Respiratory support (noninvasive ventilation or high-flow nasal cannula) applied at the time of extubation has been reported to reduce reintubation rates, but concerns regarding effectiveness have limited uptake into practice.Objectives: To determine if providing postextubation respiratory support to all patients undergoing extubation in a medical ICU would decrease the incidence of reintubation.Methods: We conducted a pragmatic, two-armed, cluster-crossover trial of adults undergoing extubation from invasive mechanical ventilation between October 1, 2017, and March 31, 2019, in the medical ICU of an academic medical center. Patients were assigned to either protocolized postextubation respiratory support (a respiratory therapist-driven protocol in which patients with suspected hypercapnia received noninvasive ventilation and patients without suspected hypercapnia received high-flow nasal cannula) or usual care (postextubation management at the discretion of treating clinicians). The primary outcome was reintubation within 96 hours of extubation.Measurements and Main Results: A total of 751 patients were enrolled. Of the 359 patients assigned to protocolized support, 331 (92.2%) received postextubation respiratory support compared with 66 of 392 patients (16.8%) assigned to usual care, a difference driven by differential use of high-flow nasal cannula (74.7% vs. 2.8%). A total of 57 patients (15.9%) in the protocolized support group experienced reintubation compared with 52 patients (13.3%) in the usual care group (odds ratio, 1.23; 95% confidence interval, 0.82 to 1.84; P = 0.32).Conclusions: Among a broad population of critically ill adults undergoing extubation from invasive mechanical ventilation at an academic medical center, protocolized postextubation respiratory support, primarily characterized by an increase in the use of high-flow nasal cannula, did not prevent reintubation compared with usual care.Clinical trial registered with www.clinicaltrials.gov (NCT0328831).

Trial registration: ClinicalTrials.gov NCT03288311.

Keywords: invasive mechanical ventilation; noninvasive respiratory support; reintubation.

Figures

Figure 1.

Postextubation respiratory support by study group. The figure displays the proportion of patients alive and receiving postextubation respiratory support (y-axis) between the time of extubation and 24 hours after extubation (x-axis) for patients in the protocolized support group (red) and usual care group (blue).

Figure 2.

Competing risk analysis of reintubation or death. In a proportional subdistribution hazards regression model of reintubation with death as the competing risks (36), the time to reintubation within 28 days of extubation did not differ significantly between the protocolized support group and the usual care group (hazard ratio, 1.07; 95% confidence interval, 0.78–1.46).

Figure 3.

Effect modification by risk of reintubation and duration of ventilation. The left panel displays the probability of reintubation within 96 hours (mean and 95% confidence interval) for patients assigned to protocolized support (red) and usual care (blue) relative to the duration of the intervention period. The duration of the intervention period was based on the time of extubation. Because postextubation respiratory support was removed at 5:00 a.m. on the day after extubation, the duration of the intervention period (x-axis) ranged from a minimum of 5 hours for patients extubated just before midnight to a maximum of 29 hours for patients extubated just before 5:00 a.m. The P value for the interaction between study group assignment and the duration of the intervention period was 0.96, suggesting that longer duration of support did not appear to make protocolized support more effective. The right panel displays the observed incidence of reintubation within 96 hours in each group relative to the number of risk factors for reintubation (17, 33). Protocolized support did not appear to reduce the risk of reintubation compared with usual care among patients with lower or higher risk of reintubation.