PT  - JOURNAL ARTICLE
AU  - Axelle Eugene
AU  - Lucie Fromont
AU  - Adrien Auvet
AU  - Olivier Baert
AU  - Willy-Serge Mfam
AU  - Francis Remerand
AU  - Thierry Boulain
AU  - Mai-Anh Nay
TI  - High-flow nasal oxygenation versus standard oxygenation for gastrointestinal endoscopy with sedation. The prospective multicentre randomised controlled ODEPHI study protocol
AID  - 10.1136/bmjopen-2019-034701
DP  - 2020 Feb 01
TA  - BMJ Open
PG  - e034701
VI  - 10
IP  - 2
4099  - http://bmjopen.bmj.com/content/10/2/e034701.short
4100  - http://bmjopen.bmj.com/content/10/2/e034701.full
SO  - BMJ Open2020 Feb 01; 10
AB  - Introduction Hypoxaemia is a major complication during gastrointestinal endoscopy (GIE) procedures (upper/lower) when performed under deep sedation in the procedure room. Standard oxygen therapy (SOT) is used to prevent hypoxaemia. Data suggest that risk factors for hypoxaemia under deep sedation during GIE are obstructive sleep apnoea syndrome, a body mass index above 30 kg/m², high blood pressure, diabetes, heart disease, age over 60 years old, high American Society of Anesthesiologists physical status class and the association of upper and lower GIE. High-flow nasal oxygenation (HFNO) may potentially improve oxygenation during GIE under deep sedation. We hypothesised that HFNO could decrease the incidence of hypoxaemia in comparison with SOT.Methods and analysis The ODEPHI (High-flow nasal oxygenation versus standard oxygenation for gastrointestinal endoscopy with sedation. The prospective multicentre randomised controlled) study is a multicentre randomised controlled trial comparing HFNO to SOT during GIE (upper and/or lower) under deep sedation administered by anaesthesiologists in the procedure room. Three hundred and eighty patients will be randomised with a 1:1 ratio in two parallel groups.The primary outcome is the occurrence of hypoxaemia, defined by a pulse oximetry measurement of peripheral capillary oxygen saturation (SpO2) below or equal to 92% during the GIE procedure. Secondary outcomes include prolonged hypoxaemia, severe hypoxaemia, need for manoeuvres to maintain upper airway patency and other adverse events.Ethics and dissemination This study has been approved by the ethics committee (CPP Sud Est Paris V, France), and patients are included after informed consent. The results will be submitted for publication in peer-reviewed journals. As provided for by French law, patients participating in the study are informed that they have the possibility to ask the investigators, once the study is completed, to be informed of the overall results of the study. Thus, a summary of the results will be sent by post to the participants on request.Trial registration number ClinicalTrials.gov Registry (NCT03829293).