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

NCT06796764 | Recruiting

• 1 other identifier: ZJU2025B0065
• Study Type: interventional
• Target: 580
• Locations: 1 country
• Sites: 3

Brief Summary

Hypoxia represents the prevailing adverse occurrence during the sedation of patients undergoing gastrointestinal endoscopy with propofol. This is particularly true for obese patients, who have a higher incidence of hypoxia. 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. This device has been purposefully designed to cater to the unique requirements of endoscopic procedures. The principal objective of this study is to assess the efficacy and safety of the COMBO Endoscopy Oropharyngeal Airway in reducing the incidence of hypoxia in obese patients undergoing gastrointestinal endoscopy under sedation.

Conditions

Hypoxia; Esophageal Cancer; Gastric Cancer

Keywords

Obese Patients; The COMBO Endoscopy Oropharyngeal Airway; Hypoxia; Sedation; Gastrointestinal Endoscopy

Outcome Measures

Primary Outcomes (1)

• The incidence of hypoxia

  75% ≤ SpO2 \< 90% for \<60 s

  Patients will be followed for the duration of hospital stay, an expected average about 2 hours

Secondary Outcomes (2)

• The incidence of sub-clinical respiratory depression

  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

  Patients will be followed for the duration of hospital stay, an expected average about 2 hours

Other Outcomes (1)

• The incidence of other adverse events

  Patients will be followed for the duration of hospital stay, an expected average about 2 hours

Study Arms (2)

the COMBO Endoscopy Oropharyngeal Airway Group

EXPERIMENTAL

In this group, patients use the COMBO Endoscopy Oropharyngeal Airway for oxygenation.

Device: the COMBO Endoscopy Oropharyngeal Airway Group

Regular Nasal Cannula Group

ACTIVE COMPARATOR

In this group, patients use the regular nasal cannula for oxygenation.

Device: Regular Nasal Cannula

Interventions

the COMBO Endoscopy Oropharyngeal Airway Group DEVICE

Using the COMBO Endoscopy Oropharyngeal Airway for oxygenation.

the COMBO Endoscopy Oropharyngeal Airway Group

Regular Nasal Cannula DEVICE

Using regular nasal cannula for oxygenation.

Regular Nasal Cannula Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhejiang University: lead

Study Sites (3)

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310000, China

RECRUITING

The Fourth Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310000, China

RECRUITING

Zhejiang Cancer hospital

Hangzhou, Zhejiang, 310000, China

RECRUITING

MeSH Terms

Conditions

Hypoxia; Esophageal Neoplasms; Stomach Neoplasms

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Stomach Diseases

Central Study Contacts

Diansan Su, Chief Physician

CONTACT

+8618616514088; diansansu@yahoo.com

Mingxia Xu

CONTACT

+8613516713435; xumingxia@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair of the Department of Anesthesiology

Study Record Dates

• First Submitted: January 22, 2025
• First Posted: January 28, 2025
• Study Start: April 11, 2025
• Primary Completion: December 4, 2025
• Study Completion: December 4, 2025
• Last Updated: September 10, 2025

Record last verified: 2025-08

Locations

CN (3)