Respiratory outcomes and survival after unplanned extubation in the NICU: a prospective cohort study from the SEPREVEN trial

Abstract

Objective: To compare reintubation rates after planned extubation and unplanned extubation (UE) in patients in neonatal intensive care units (NICUs), to analyse risk factors for reintubation after UE and to compare outcomes in patients with and without UE.

Design: Prospective, observational study nested in a randomised controlled trial (SEPREVEN/Study on Epidemiology and PRevention of adverse EVEnts in Neonates). Outcomes were expected to be independent of the intervention tested.

Setting: 12 NICUs in France with a 20-month follow-up, starting November 2015.

Patients: n=2280 patients with a NICU stay >2 days, postmenstrual age ≤42 weeks on admission.

Interventions/exposure: Characteristics of UE (context, timing, sedative administration in the preceding 6 hours, weaning from ventilation at time of UE) and patients.

Main outcome measures: Healthcare professional-reported UE rates, reintubation/timing after extubation, duration of mechanical ventilation, mortality and bronchopulmonary dysplasia (BPD).

Results: There were 162 episodes of UE (139 patients, median gestational age (IQR) 27.3 (25.6-31.7) weeks). Cumulative reintubation rates within 24 hours and 7 days of UE were, respectively, 50.0% and 57.5%, compared with 5.5% and 12.3% after a planned extubation. Independent risk factors for reintubation within 7 days included absence of weaning at the time of UE (HR, 95% CI) and sedatives in the preceding 6 hours (HR 1.93, 95% CI 1.04 to 3.60). Mortality at discharge did not differ between patients with planned extubation or UE. UE was associated with a higher risk of BPD.

Conclusion: In the SEPREVEN trial, reintubation followed UE in 58% of the cases, compared with 12% after planned extubation.

Trial registration number: NCT02598609.

Keywords: Intensive Care Units, Neonatal; Neonatology; Respiratory Medicine.

Figure 1. Flow chart. *One unique unplanned extubation (UE) in 122 patients (87.8%), two UEs in 11 patients (7.9%) and three UEs in 6 patients (4.3%). SEPREVEN, Study on Epidemiology and PRevention of adverse EVEnts in Neonates.

Figure 2. Cumulative reintubation rates over time after planned extubation and unplanned extubation. In the global population, reintubation rates by 30 min after extubation were statistically higher after unplanned than planned extubations (61 of 160 (38.1%) vs 44 of 2792 (1.6%), p<0.001), within 24 hours (8 of 160 (50.0%) vs 154 of 2792 (5.5%), p<0.001), 72 hours (87 of 160 (54.4%) vs 242 of 2792 (8.7%), p<0.001) and 7 days (9 of 160 (57.5%) vs 343 of 2792 (12.3%), p<0.001) after an extubation. From 24 hours to 7 days, reintubations after planned extubations increased from 154 to 343 of 2792 (rate +6.8%) and after unplanned extubations from 80 to 92 of 160 (rate +7.5%), at similar rates (p=0.721). For the extremely low gestational age neonates (ELGANs), unplanned extubation compared with planned extubation was associated with a higher risk of reintubation: within 30 min (26 of 1055 (2.5%) vs 42 of 92 (45.7%), p<0.001), 24 hours (92 of 1055 (8.7%) vs 52 of 92 (56.5%), p<0.001), 72 hours (154 of 1055 (14.6%) vs 58 of 92 (63.0%), p<0.001) and 7 days (233 of 1055 (22.1%) vs 62 of 92 (67.4%), p<0.001) after an extubation. Crude cumulative rates. The dotted lines correspond to an (exact binomial) CI calculated for each rate at each time point. (A) After planned extubation (entire population), (B) after unplanned extubation (entire population), (C) after planned extubation (ELGANs) and (D) after unplanned extubation (ELGANs).