Preoxygenation in difficult airway management: high-flow oxygenation by nasal cannula versus face mask (the PREOPTIDAM study). Protocol for a single-centre randomised study

Abstract

IntroductionAlthough preoxygenation and airway management respond to precise algorithms, difficult intubation (DI) remains a daily challenge in intensive care units and in the operating rooms because of its frequent complications, including hypoxaemia. To prevent desaturation during DI, high-flow oxygenation by nasal cannula (HFNC) could prove beneficial. Indeed, contrary to standard preoxygenation device, it can be held in place throughout the intubation trying to perform apnoeic oxygenation during DI. Hence, recent guidelines recommend HFNC during DI, but its relevance has never been evaluated in this setting in a large randomised study until now.Methods and analysisThe PREOPTIDAM trial is a prospective, single-centre, randomised, controlled study in Nantes University Hospital. In anticipated DI, we hypothesised that HFNC can decrease the incidence of desaturation ≤94% or face mask ventilation from 16% to 4% compared with standard device. Using a two-sided t-test with a first species risk of 5% and 80% power, a total of 186 patients will be included. Using a computer-generated randomisation, with a 1:1 allocation ratio, patients will be randomised to HFNC or face mask preoxygenation. Randomisation will be stratified on intubation sequence: Rapid sequence intubation or awake fibreoptic intubation. The primary objective is to determine whether HFNC is more efficient than standard oxygenation techniques to prevent desaturation ≤94% or face mask ventilation during DI. Intent-to-treat and per-protocol analysis are planned for the primary outcome.Ethics and disseminationThe study project has been approved by an independent ethics committee. Written informed consent will be obtained before study inclusion. Participant recruitment begins in September 2018. Results will be submitted to international peer-reviewed medical journals.Trial registration numberNCT03604120.

A special oropharyngeal oxygenation device to facilitate apneic oxygenation in comparison to high flow oxygenation devices

“…Since desoxygenation regularly occurs during intubation attempts, 15 16 17 performing preoxygenation carefully has proven to reduce deoxygenating events during intubation attempts. 18 19 20 21 22 23 Applying oxygen in high concentration may be in additional safety tool to maintain apneic oxygenation if breathing of patients is impaired due to sedating agents.…”

High-flow nasal cannula therapy as apneic oxygenation during endotracheal intubation in critically ill patients in the intensive care unit: a systematic review and meta-analysis

“…Several ongoing RCTs are currently evaluating the efficacy of HFNC as apneic oxygenation during invasive procedures in various fields including diagnostic, emergency, and critical care medicine [46][47][48] . Pre-and Apneic High-Flow Oxygenation for RApid Sequence Intubation in The Emergency Department (Pre-AeRATE) 47 is a multi-center RCT, aiming to elucidate whether HFNC improves oxygen levels during endotracheal intubation, thereby reducing the risk of hypoxemia during rapid sequence intubation.…”

Efficiency of different flows for apneic oxygenation when using high flow nasal oxygen application – a technical simulation

“…The time until desaturation occurs can be prolonged by applying oxygen into the airway and thus providing apneic oxygenation. Established methods to facilitate apneic oxygenation may be application of high flow nasal oxygen via nasal cannulas [ 1 , 2 ] and some guidelines simply recommend to apply “a bulk full of oxygen”, to maintain apneic oxygenation [ 3 ]. From the physiological view, optimum preoxygenation and removal of nitrogen from the lungs are essential for sufficient apneic oxygenation.…”