Background: We aimed to determine whether high-flow nasal oxygen could reduce the incidence of decreased peripheral oxygen saturation (SpO 2 ) compared with standard oxygen in patients at risk of hypoxaemia undergoing gastrointestinal endoscopy under deep sedation. Methods: This was a multicentre, randomised controlled trial with blinded assessment of the primary outcome evaluating high-flow nasal oxygen (gas flow 70 L min À1 , inspired oxygen fraction 0.50) or standard oxygen delivered via nasal cannula or face mask (6 L min À1 ) or nasopharyngeal tube (5 L min À1 ) in patients at risk of hypoxaemia (i.e. >60 yr old, or with underlying cardiac or respiratory disease, or with ASA physical status >1, or with obesity or sleep apnoea syndrome) undergoing gastrointestinal endoscopy. The primary endpoint was the incidence of SpO 2 92%. Secondary outcomes included prolonged or severe desaturations, need for manoeuvres to maintain free upper airways, and other adverse events. Results: In 379 patients, a decrease in SpO 2 92% occurred in 9.4% (18/191) for the high-flow nasal oxygen group, and 33.5% (63/188) for the standard oxygen groups (adjusted absolute risk difference, e23.4% [95% confidence interval (CI), e28.9 to e16.7]; P<0.001). Prolonged desaturation (>1 min) and manoeuvres to maintain free upper airways were less frequent in the high-flow nasal oxygen group than in the standard oxygen group (7.3% vs 14.9%, P¼.02, and 11.1% vs 32.4%, P<0.001). Conclusions: In patients at risk of hypoxaemia undergoing gastrointestinal endoscopy under deep sedation, use of highflow nasal oxygen significantly reduced the incidence of peripheral oxygen desaturation. Clinical trial registration: NCT03829293.
The incidence of perineural catheter colonization is low with subcutaneous tunneling. Controlled randomized studies are warranted to determine whether this procedure decreases the risk for infection.
Major complications after the use of CPSN are not in fact rare. The incidence of severe neuropathy or infection complications is, respectively, 0.50% and 0.25%. However, the insertion of CPSN could be considered effective and is associated with only a few minor complications.
IntroductionHypoxaemia 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 analysisThe ODEPHI (High-flow nasaloxygenation versus standardoxygenation for gastrointestinalendoscopy withsedation. 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 disseminationThis 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 numberClinicalTrials.gov Registry (NCT03829293).
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