Nasal high-flow therapy to Optimise Stability during Intubation: the NOSI pilot trial

Abstract

ObjectiveIn adult patients with acute respiratory failure, nasal high-flow (NHF) therapy at the time of intubation can decrease the duration of hypoxia. The objective of this pilot study was to calculate duration of peripheral oxygen saturation below 75% during single and multiple intubation attempts in order to inform development of a larger definitive trial.Design and settingThis double-blinded randomised controlled pilot trial was conducted at a single, tertiary neonatal centre from October 2020 to October 2021.ParticipantsInfants undergoing oral intubation in neonatal intensive care were included. Infants with upper airway anomalies were excluded.InterventionsInfants were randomly assigned (1:1) to have NHF 6 L/min, FiO21.0 or NHF 0 L/min (control) applied during intubation, stratified by gestational age (<34 weeks vs ≥34 weeks).Main outcome measuresThe primary outcome was duration of hypoxaemia of <75% up to the time of successful intubation,Results43 infants were enrolled (26 <34 weeks and 17 ≥34 weeks) with 50 intubation episodes. In infants <34 weeks’ gestation, median duration of SpO2of <75% was 29 s (0–126 s) vs 43 s (0–132 s) (p=0.78, intervention vs control). Median duration of SpO2 of<75% in babies ≥34 weeks’ gestation was 0 (0–32 s) vs 0 (0–20 s) (p=0.9, intervention vs control).ConclusionThis pilot study showed that it is feasible to provide NHF during intubation attempts. No significant differences were noted in duration of oxygen saturation of <75% between groups; however, this trial was not powered to detect a difference. A larger, higher-powered blinded study is warranted.

Providing Oxygen during Intubation in the NICU Trial (POINT): study protocol for a randomised controlled trial in the neonatal intensive care unit in the USA

“…However, 26% of intubations in the trial were performed without premedication, and thus the neonates were not apnoeic during the intubation 15. The second trial demonstrated no difference in the primary outcome of duration of oxygen desaturation 14. Additionally, both studies used high-flow NC to provide apnoeic oxygenation which costs more and requires additional time and resources to set up compared with regular low-flow NC 14 15.…”

“…Emerging data demonstrate mixed results for the use of apnoeic oxygenation among neonates. 14 15 One trial demonstrated a significant improvement in the composite outcome of intubation success without physiological deterioration. However, 26% of intubations in the trial were performed without premedication, and thus the neonates were not apnoeic during the intubation.…”

“… 15 The second trial demonstrated no difference in the primary outcome of duration of oxygen desaturation. 14 Additionally, both studies used high-flow NC to provide apnoeic oxygenation which costs more and requires additional time and resources to set up compared with regular low-flow NC. 14 15 We designed this study to test the efficacy, feasibility and safety of apnoeic oxygenation delivered via NC among neonates with apnoea during tracheal intubation in the NICU.…”

“…Emerging data demonstrate mixed results for the use of apnoeic oxygenation among neonates 14 15. One trial demonstrated a significant improvement in the composite outcome of intubation success without physiological deterioration.…”