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

Status: Recruiting
Location: See all (10) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: t
View:

• 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.

Locations
Other Locations
China
The First Affliated Hospital, Zhejiang University School Of Medicine
RECRUITING
Hangzhou
Shangdong Provincial Qianfoshan Hospital
RECRUITING
Jinan
The First Affiliated Hospital Of Nanchang University
RECRUITING
Nanchang
The First Affiliated Hospital with Nanjing Medical University
RECRUITING
Nanjing
Fudan University Shanghai Cancer Center
RECRUITING
Shanghai
Renji Hospital
RECRUITING
Shanghai
Tongji Hospital Of Tongji University
RECRUITING
Shanghai
Xinhua Hospital Affliated To Shanghai Jiaotong University School Of Medicine
RECRUITING
Shanghai
Tianjin Mediacal University General Hospital
RECRUITING
Tianjin
The First Affliated Hospital of Xi'an Jiangtong University
RECRUITING
Xi’an
Contact Information
Primary
Diansan Su, Dr.
diansansu@yahoo.com
+862168383702
Backup
Yuhan Zhang, B.S
1092619255@qq.com
+862168383702
Time Frame
Start Date: 2023-12-27
Estimated Completion Date: 2025-12-27
Participants
Target number of participants: 1200
Treatments
Experimental: the COMBO Endoscopy Oropharyngeal Airway Group
In this group, patients use the COMBO Endoscopy Oropharyngeal Airway for oxygenation.
Active_comparator: Regular Nasal Cannula Group
In this group, patients use the regular nasal cannula for oxygenation.
Sponsors
Leads: RenJi Hospital

This content was sourced from clinicaltrials.gov