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

Sponsor

RenJi Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06081647

Collaborator

Tianjin Medical University General Hospital (Other), The First Affiliated Hospital with Nanjing Medical University (Other), First Affiliated Hospital Xi'an Jiaotong University (Other), Qianfoshan Hospital (Other), Fudan University (Other)

1,200

Enrollment

Locations

Arms

Anticipated Duration (Months)

200

Patients Per Site

16.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypoxia Gastric Polyp Colon Cancer Esophageal Cancer	Device: the COMBO Endoscopy Oropharyngeal Airway Device: Regular Nasal Cannula	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

1200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Oct 9, 2023

Anticipated Primary Completion Date :

Oct 9, 2023

Anticipated Study Completion Date :

Oct 9, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: the COMBO Endoscopy Oropharyngeal Airway Group In this group, patients use the COMBO Endoscopy Oropharyngeal Airway for oxygenation.	Device: the COMBO Endoscopy Oropharyngeal Airway Using the COMBO Endoscopy Oropharyngeal Airway for oxygenation.
Active Comparator: Regular Nasal Cannula Group In this group, patients use the regular nasal cannula for oxygenation.	Device: Regular Nasal Cannula Using regular nasal cannula for oxygenation.

Arm

Intervention/Treatment

Experimental: the COMBO Endoscopy Oropharyngeal Airway Group

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

Device: the COMBO Endoscopy Oropharyngeal Airway

Using the COMBO Endoscopy Oropharyngeal Airway for oxygenation.

Active Comparator: Regular Nasal Cannula Group

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

Device: Regular Nasal Cannula

Using regular nasal cannula for oxygenation.

Outcome Measures

Primary Outcome Measures

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

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%)
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)

Other Outcome Measures

The incidence of other adverse events [Patients will be followed for the duration of hospital stay, an expected average about 2 hours]
Other adverse events recorded by tools proposed by the World Society of Intravenous Anesthesia International Sedation Task Force

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The First Affiliated Hospital with Nanjing Medical University	Nanjing	Jiangsu	China	210029
2	Shangdong Provincial Qianfoshan Hospital	Jinan	Shandong	China	250014
3	Fudan University Shanghai Cancer Center	Shanghai	Shanghai	China	200032
4	Renji Hospital	Shanghai	Shanghai	China	200127
5	The First Affliated Hospital of Xi'an Jiangtong University	Xi'an	Shanxi	China	710061
6	Tianjin Mediacal University General Hospital	Tianjin	Tianjin	China	300052