Clinical Trial Protocol
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Pre- and Apnoeic high flow oxygenation for RApid sequence intubation in The Emergency department (Pre-AeRATE): study protocol for a multicentre, randomised controlled trial.

Trials 2019 April 5
BACKGROUND: Maintaining adequate oxygenation during rapid sequence intubation (RSI) is imperative to prevent peri-intubation adverse events that can lead to increased duration of hospital and intensive care unit stay, or a prolonged vegetative state requiring long-term institutionalisation. Despite employing current best practices during RSI, desaturation during intubation still occurs. High-flow nasal cannula (HFNC) oxygenation may potentially improve oxygenation during pre- and apnoeic oxygenation to allow a longer safe apnoeic time for RSI.

OBJECTIVE: We aim to test the hypothesis that the use of humidified high-flow oxygenation via nasal cannula at 60 L/min maintains higher oxygen saturation compared with current usual care of non-rebreather mask and standard nasal cannula at an oxygen flow rate of 15 L/min for pre- and apnoeic oxygenation.

METHODS: This is a multi-centre randomised controlled trial enrolling adult patients aged 21 years and older who require rapid sequence intubation due to medical, surgical, or traumatic conditions in the Emergency Departments (EDs) of the National University Hospital and the Ng Teng Fong General Hospital. Eligible patients will undergo randomisation at an equal ratio into intervention or control arms. The primary endpoint will be the lowest oxygen saturation achieved during the first intubation attempt from time of administration of paralytic agent until quantitative end-tidal carbon dioxide is detected if the first intubation attempt is successful, or until the start of the second attempt if it is not.

DISCUSSION: Prolongation of safe apnoea time through maintenance of oxygen saturation above 90% using HFNC oxygenation during RSI could potentially change current clinical practice, improve standard of care, and translate to better outcomes for patients.

TRIAL REGISTRATION: ClinicalTrials.gov, NCT03396094 . Registered on 10 January 2018.

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