Trial reportBMC anesthesiology2026
Combination of COMBO endoscopy oropharyngeal airway and high-flow nasal cannula oxygenation in sedated gastrointestinal endoscopy for morbidly obese patients: a Simon two-stage trial.
Trial report in BMC anesthesiology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06812403 (Combination COMBO Endoscopy Oropharyngeal Airway With High-Flow Nasal Cannula Oxygenation in Sedated Gastrointestinal Endoscopy for Obese Patients), which is not on this map. Not yet cited in PubMed.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Combination COMBO Endoscopy Oropharyngeal Airway With High-Flow Nasal Cannula Oxygenation in Sedated Gastrointestinal Endoscopy for Obese Patients
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors.
Funding
Abstract
backgroundHypoxemia during sedated gastrointestinal endoscopy affects over 40% of morbidly obese (BMI ≥ 35 kg/m2) patients. High-flow nasal cannula (HFNC) alone often fails due to persistent airway collapse. The COMBO endoscopy oropharyngeal airway provides mechanical support while delivering oxygen. This study aimed to assess the efficacy of combined COMBO-HFNC oxygenation for preventing hypoxemia in this high-risk population.
methodsIn a prospective, single-centre, Simon two-stage trial, 50 adults with morbid obesity scheduled for gastrointestinal endoscopy under propofol-alfentanil sedation received COMBO-HFNC oxygenation. The primary endpoint was hypoxemia (SpO₂ 75–90% for < 60 s) compared with a historical rate of 40%. Secondary endpoints were subclinical respiratory depression (SpO₂ 90–95%) and severe hypoxemia (SpO₂ < 75% or 75–90% ≥ 60 s). Rates were analysed with an exact one-sided binomial test (α = 0.05).
resultsAll 50 participants completed the study. No patient developed hypoxemia (0%), significantly lower than the historical 40% (P < 0.001). Subclinical respiratory depression occurred in 8 patients (16%), and no severe hypoxaemic episodes were recorded. Transient hypotension occurred in 3 patients (6%), with no other complications.
conclusionsCOMBO-HFNC oxygenation was associated with a 0% hypoxemia rate in morbidly obese patients undergoing sedated endoscopy without increasing adverse events. These findings suggest potential clinical value compared with historical conventional oxygenation strategies, but require confirmation in future multicentre randomized controlled trials to establish causal inference.
trial registrationThe trial was registered at the ClinicalTrials.gov on 1 February 2025 (NCT06812403).
Indexed as
Identifiers
What Socratic holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.