RecruitingNot ApplicableNCT06081647

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

The Efficacy and Safety of the COMBO Endoscopy Oropharyngeal Airway Reduce the Incidence of Hypoxia in Patients Undergoing Gastrointestinal Endoscopy Sedated With Propofol.


Sponsor

RenJi Hospital

Enrollment

1,200 participants

Start Date

Dec 27, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This study evaluates a special type of airway device called a COMBO oropharyngeal airway that helps keep patients breathing safely during sedated endoscopy (camera examination of the stomach or colon). Researchers want to know if it is safe and effective. **You may be eligible if...** - You are between 18 and 60 years old - You are scheduled for a stomach or colon endoscopy procedure lasting under 45 minutes - You have a BMI between 18.5 and 30 - Your blood oxygen level is 95% or above while breathing room air - You have low-to-moderate anesthesia risk (ASA class I-II) **You may NOT be eligible if...** - You have bleeding problems, oral/nasal bleeding tendency, or anatomical issues that prevent airway device placement - You have severe heart, kidney, or liver disease - You have COPD or other significant lung conditions requiring extra oxygen - You have elevated pressure in the skull - You have an active respiratory infection, fever, or are pregnant or breastfeeding - You have a history of substance abuse (drugs or alcohol) in the past 2 years - You have significant mental health or neurological conditions (Parkinson's, epilepsy, schizophrenia, etc.) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEthe COMBO Endoscopy Oropharyngeal Airway

Using the COMBO Endoscopy Oropharyngeal Airway for oxygenation.

DEVICERegular Nasal Cannula

Using regular nasal cannula for oxygenation.


Locations(10)

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, China

The First Affiliated Hospital Of Nanchang University

Nanchang, Jiangxi, China

Shangdong Provincial Qianfoshan Hospital

Jinan, Shandong, China

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Renji Hospital

Shanghai, Shanghai Municipality, China

Tongji Hospital Of Tongji University

Shanghai, Shanghai Municipality, China

Xinhua Hospital Affliated To Shanghai Jiaotong University School Of Medicine

Shanghai, Shanghia, China

The First Affliated Hospital of Xi'an Jiangtong University

Xi’an, Shanxi, China

Tianjin Mediacal University General Hospital

Tianjin, Tianjin Municipality, China

The First Affliated Hospital, Zhejiang University School Of Medicine

Hangzhou, Zhejiang, China

View Full Details on ClinicalTrials.gov

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NCT06081647


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