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Abstract
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).
- adult anaesthesia
- endoscopy
- protocols & guidelines
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Footnotes
AE and LF contributed equally.
Contributors M-AN, LF, AE and TB designed the study and wrote the study protocol. All authors gave final approval of the manuscript. TB determined the sample size and planned the statistical analysis. M-AN is the principal investigator and coordinator of ODEPHI. M-AN, AE, LF, AA, W-SM, OB and FR designed the implementation aspects of this protocol. AE and LF have collected the data.
Funding Costs related to this research will be covered by the sponsor: Centre Hospitalier Régional d’Orléans. For this trial, the firm Fisher & Paykel (Auckland, New Zealand) provides high-flow oxygen therapy equipment to all the participating centres but has no other role in the study, with the exception of a minor assistance in preparing the manuscript.
Competing interests None declared.
Patient consent for publication Not required.
Ethics approval The study was approved for all centres by the institutional review board of Orléans’ Hospital, as well as the regional ethics committee (Comité de Protection des Personnes Paris Sud Est V) on 07 March 2019. “No DSMB has been established for this trial. The protocol was approved by an Ethics Committee which did not ask for a DSMB. The study has been classified as a study bringing minimal risk by the Ethics committee and the French Ministry of Health. The study is carried out in centres with an experienced anaesthesia team. Patients are continuously monitored clinically and through multiparametric monitoring by an anaesthesia team during the procedure. Several studies have been carried out on HFNO and have never encountered any major incidents. The occurrence of death and any serious adverse event during the procedure is timely reported to the sponsor (who in turn is responsible for timely declaration to the National Health Authorities).” The ethics committee (CPP of Paris Sud Est V, France) approved our study (19-ORLE-01) on March 2019. The study is conducted in accordance with the current revision of the Declaration of Helsinki, 1996, International Conference on Harmonisation Note for Guidance on Good Clinical Practise (ICH GCP) and the applicable French regulatory requirements.
Provenance and peer review Not commissioned; externally peer reviewed.