Using a new airway device to reduce low oxygen levels during endoscopy in obese patients

COMBO Endoscopy Oropharyngeal Airway Reduces Hypoxia During Sedated Gastrointestinal Endoscopy in Obese Patients: A Multicenter, Randomized, Controlled Clinical Trial

This study tests if a new airway device can help obese patients keep their oxygen levels up during gastrointestinal endoscopy compared to using a regular nasal cannula.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 580 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Zhejiang University (Academic / other)
• Locations: 3 sites (Hangzhou, Zhejiang and 2 other locations)
• Trial ID: NCT06796764 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of the COMBO Endoscopy Oropharyngeal Airway in preventing hypoxia in obese patients undergoing gastrointestinal endoscopy while sedated. The device integrates capnography monitoring, a bite block, oxygen support, and oropharyngeal airway management to address the specific needs of these patients. The study aims to compare the outcomes of patients using this device against those using a regular nasal cannula during the procedure. By focusing on a high-risk population, the trial seeks to enhance patient safety and procedural success.

Who should consider this trial

Good fit: Ideal candidates for this study are obese patients aged 18 to 70 with a BMI of 28 kg/m² or higher, undergoing gastroendoscopy or colonoscopy.

Not a fit: Patients with severe cardiac insufficiency, chronic obstructive pulmonary disease, or other significant health issues that contraindicate the use of an oropharyngeal airway may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could significantly reduce the incidence of hypoxia in obese patients during gastrointestinal endoscopy, improving patient safety.

How similar studies have performed: While the specific device is novel, similar studies have shown that improved airway management can enhance safety during sedation in high-risk populations.

Eligibility criteria

Inclusion Criteria:

* Age 18≤ Age ≤70.
* BMI ≥ 28 kg/m².
* The ASA classification ranges from I to II.
* Patients have signed the informed consent form.
* Patients undergoing gastroendoscopy and colonoscopy procedure.
* The estimated duration of the procedure does not exceed 45 minutes.

Exclusion Criteria:

* Patients who exhibit contraindications to oropharyngeal airway ventilation, such as coagulation disorders, a predisposition to oral and nasal bleeding, mucosal damage, or anatomical constraints impeding oropharyngeal channel placement.
* Severe cardiac insufficiency, defined as a maximal exercise capacity of less than 4 metabolic equivalents (METs).
* Profound renal insufficiency necessitating preoperative dialysis.
* A confirmed severe liver dysfunction.
* Patients diagnosed with chronic obstructive pulmonary disease (COPD) or those presently experiencing other acute and chronic pulmonary conditions necessitating prolonged or intermittent oxygen therapy.
* Elevated intracranial pressure.
* Upper respiratory tract infections, encompassing the oral, nasal, and pharyngeal regions.
* Fever, defined as a core body temperature exceeding 37.5 degrees Celsius.
* Pregnancy or lactation.
* Hypersensitivity reactions to sedatives like propofol or medical equipment such as adhesive tape.
* Urgent surgical intervention.
* Polytrauma.
* Peripheral oxygen saturation (SpO2) levels below 95% while breathing room air preoperatively.
* BMI\<28 kg/m².
* Patients with a documented history of substance abuse, specifically drugs and/or alcohol, within the two years preceding the commencement of the screening period. Substance abuse in this context is defined as consuming more than three standard alcoholic beverages daily, roughly equivalent to 10g of alcohol or 50g of Chinese Baijiu.
* Patients with a history of mental and neurological disorders, including but not limited to depression, severe central nervous system depression, Parkinson's disease, basal ganglia lesions, schizophrenia, epilepsy, Alzheimer's disease, and myasthenia gravis.
* Presently engaged in concurrent participation in additional clinical trials.
* Patients considered ineligible by researchers for inclusion in this clinical trial.

Where this trial is running

Hangzhou, Zhejiang and 2 other locations

• The First Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (Recruiting)
• The Fourth Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (Recruiting)
• Zhejiang Cancer hospital — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Study coordinator: Diansan Su, Chief Physician

Conditions Hypoxia; Esophageal Cancer; Gastric Cancer; Obese Patients; The COMBO Endoscopy Oropharyngeal Airway; Sedation; Gastrointestinal Endoscopy