High-flow nasal oxygenation or standard oxygenation for gastrointestinal endoscopy with sedation in patients at risk of hypoxaemia: a multicentre randomised controlled trial (ODEPHI trial).

BACKGROUND: We aimed to determine whether high-flow nasal oxygen could reduce the incidence of decreased peripheral oxygen saturation (SpO2) 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-1, inspired oxygen fraction 0.50) or standard oxygen delivered via nasal cannula or face mask (6 L min-1) or nasopharyngeal tube (5 L min-1) 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 SpO2 ≤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 SpO2 ≤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, -23.4% [95% confidence interval (CI), -28.9 to -16.7]; 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%, P=.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 high-flow nasal oxygen significantly reduced the incidence of peripheral oxygen desaturation. CLINICAL TRIAL REGISTRATION: NCT03829293.

Laparoscopic versus full robotic Roux-en-Y gastric bypass: retrospective, single-center study of the feasibility and short-term results.

Robotic bariatric surgery is an alternative to laparoscopy. It gives the surgeon an accurate three-dimensional view, allowing complex maneuvers while maintaining full control of the theater. We report our experience with this innovative surgery compared with laparoscopy during Roux-en-Y gastric bypass, to demonstrate its safety and feasibility. Our single-center study retrospectively identified obese patients who underwent either laparoscopic or robot-assisted gastric bypass procedures over a 2-year period. Demographics, intraoperative outcomes, mortality and morbidity data were collected. Of the 343 gastric bypass procedures identified, 147 were laparoscopic and 196 robotic-assisted. There were significant differences in age and BMI, being younger and more obese in the robotic group (p = 0.001). The mean operative time was longer in the robotic group; the mean additional time was required for docking, otherwise, the surgical time between groups was comparable. Operative time decreased in line with increasing skills. The conversion rate to laparotomy was 1% (robotic group). Morbidity was generally lower in the robotic group compared with laparoscopy, (hemorrhages 2.5% vs. 6.8%, respectively; anastomotic fistulas 0.5% vs. 2.7%). Statistically, results seem to favor robotic assistance. No mortality was observed in either group. The mean hospital stay was significantly shorter in the robotic group (p = 0.007). Robotic gastric bypass is feasible and, within the reach of every laparoscopic surgeon. Its results are comparable to laparoscopy and surgery is facilitated in higher BMI patients. Randomized, prospective studies are necessary to support our results.

High-flow nasal oxygenation versus standard oxygenation for gastrointestinal endoscopy with sedation. The prospective multicentre randomised controlled ODEPHI study protocol.

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).