The Efficacy and Safety of the COMBO Endoscopy Oropharyngeal Airway in Gastrointestinal Endoscopy Procedure

Not Applicable

Not yet recruiting

• Conditions: Gastric Polyp; Colon Cancer; Hypoxia; Esophageal Cancer
• Interventions: Device: Regular Nasal Cannula; Device: the COMBO Endoscopy Oropharyngeal Airway

• Registration Number: NCT06081647
• Lead Sponsor: RenJi Hospital

Brief Summary

Hypoxia represents the prevailing adverse occurrence during the sedation of patients undergoing gastrointestinal endoscopy with propofol. 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 our randomized study is to assess the efficacy and safety of the COMBO Endoscopy Oropharyngeal Airway reduce the incidence of hypoxia on patients undergoing gastrointestinal endoscopy under propofol sedation.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-19
• Status Verified: 2023-10
• Study First Submitted QC: 2023-10-07
• Last Update Submitted: 2023-10-07
• Study Start: 2023-10-09
• Primary Completion: 2023-10-09
• Study First Posted: 2023-10-13
• Last Update Posted: 2023-10-13
• Study Completion: 2024-10-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1200

Inclusion Criteria

• Age 18≤ Age ≤60.
• Patients undergoing gastroendoscopy and/or colonoscopy procedure.
• Patients have signed the informed consent form.
• The ASA classification ranges from I to II.
• 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<18.5 or BMI>30.
• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Regular Nasal Cannula Group	Regular Nasal Cannula	In this group, patients use the regular nasal cannula for oxygenation.
the COMBO Endoscopy Oropharyngeal Airway Group	the COMBO Endoscopy Oropharyngeal Airway	In this group, patients use the COMBO Endoscopy Oropharyngeal Airway for oxygenation.

Primary Outcome Measures

Name	Time	Method
The incidence of hypoxia	Patients will be followed for the duration of hospital stay, an expected average about 2 hours	(75% ≤ SpO2 \< 90% for \<60 s)

Secondary Outcome Measures

Name	Time	Method
The incidence of severe hypoxia	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)
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%)

Trial Locations

Locations (6)

Fudan University Shanghai Cancer Center; 🇨🇳 Shanghai, Shanghai, China

Shangdong Provincial Qianfoshan Hospital; 🇨🇳 Jinan, Shandong, China

The First Affiliated Hospital with Nanjing Medical University; 🇨🇳 Nanjing, Jiangsu, China

The First Affliated Hospital of Xi'an Jiangtong University; 🇨🇳 Xi'an, Shanxi, China

Renji Hospital; 🇨🇳 Shanghai, Shanghai, China

Tianjin Mediacal University General Hospital; 🇨🇳 Tianjin, Tianjin, China