Esophageal Cancer, Gastric Cancer, Hypoxemia, Morbidly Obese Patients
Conditions
Keywords
COMBO Endoscopy Oropharyngeal Airway, Hypoxemia, Sedation, Gastrointestinal Endoscopy, high-flow nasal cannula
Brief summary
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.
Interventions
DEVICECOMBO Endoscopy Oropharyngeal Airway with High-Flow Nasal Cannula Oxygenation
Using the COMBO endoscopy oropharyngeal airway with High-Flow Nasal Cannula Oxygenation in sedated gastrointestinal endoscopy for morbidly obese patients
In this group, patients use high-flow nasal cannula oxygenation
Sponsors
Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of hypoxemia | Patients will be followed for the duration of hospital stay, an expected average about 2 hours | 75% ≤ SpO2 \< 90% for \<60 s |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of sub-clinical respiratory depression | Patients will be followed for the duration of hospital stay, an expected average about 2 hours | 90% ≤ SpO2 \< 95% |
| The incidence of severe hypoxaemia | Patients will be followed for the duration of hospital stay, an expected average about 2 hours | SpO2 \< 75% or 75% ≤ SpO2 \< 90% for ≥60 s |
Countries
China
Contacts
CONTACTDiansan Su, Chief Physician
CONTACTMingxia Xu
Outcome results
None listed