Clinical trial · Interventional
Combination of COMBO Endoscopy Oropharyngeal Airway and HFNC Oxygenation in Sedated Gastrointestinal Endoscopy for Morbidly Obese Patients
Combination of COMBO Endoscopy Oropharyngeal Airway and High-flow Nasal Cannula Oxygenation in Sedated Gastrointestinal Endoscopy for Morbidly Obese Patients: a Multicenter, Randomized, Controlled Clinical Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Hypoxaemia during sedated gastrointestinal endoscopy exceeds 40 % in morbidly obese (BMI ≥ 35 kg m-²) patients. High-flow nasal cannula alone often fails because of persistent airway collapse. A recent innovation in this domain is the COMBO Endoscopy Oropharyngeal Airway-a multifaceted device that encompasses capnography monitoring, bite block , oxygenation support, and oropharyngeal airway management.The purpose of this study is to investigate whether the combination of the COMBO Endoscopy Oropharyngeal Airway and High-Flow Nasal Cannula oxygenation reduces the incidence of hypoxemia in this population.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Hypoxemia | — | UNRESOLVED | — |
| Morbidly Obese Patients | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| COMBO Endoscopy Oropharyngeal Airway with High-Flow Nasal Cannula Oxygenation | Device | — | UNRESOLVED |
| High-Flow Nasal Cannula Oxygenation | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- COMBO Endoscopy Oropharyngeal Airway with High-Flow Nasal Cannula Oxygenation
- description
- In this group, patients use the COMBO Endoscopy Oropharyngeal Airway with High-Flow Nasal Cannula Oxygenation
- interventionNames
- Device: COMBO Endoscopy Oropharyngeal Airway with High-Flow Nasal Cannula Oxygenation
- type
- ACTIVE_COMPARATOR
- label
- High-Flow Nasal Cannula Oxygenation
- description
- In this group, patients use the High-Flow Nasal Cannula Oxygenation
- interventionNames
- Device: High-Flow Nasal Cannula Oxygenation
Primary outcomes (1)
- measure
- The incidence of hypoxemia
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 18 years. * BMI ≥ 35 kg/m². * Patients undergoing gastroscopy or gastrointestinal endoscopy. * The estimated duration of the procedure does not exceed 45 minutes. * Patients have signed the informed consent form. Exclusion Criteria: * Coagulation disorders or bleeding tendency (e.g., oral/nasal bleeding risk, mucosal injury, oropharyngeal obstruction) making oropharyngeal airway placement unsafe or unfeasible. * Active upper respiratory tract infection (oral, nasal, or pharyngeal), or fever (core temperature \>37.5°C). * Chronic obstructive pulmonary disease or other acute/chronic pulmonary diseases requiring long-term or intermittent oxygen therapy, or preoperative SpO₂ ≤ 92% on room air. * Severe organ dysfunction, including: Cardiac insufficiency (\<4 METs), Severe renal insufficiency (requiring dialysis), Diagnosed severe hepatic insufficiency, Increased intracranial pressure, ASA physical status ≥ IV. * Confirmed pregnancy or current breastfeeding. * Known allergy to sedatives (e.g., propofol) or medical adhesives. * Multiple traumatic injuries. * Current participation in another clinical trial. * Other conditions deemed unsuitable by the investigator.
References
Publications (0)
Data not yet available