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

Primary Purpose

Hypoxia, Gastric Polyp, Colon Cancer

Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
the COMBO Endoscopy Oropharyngeal Airway
Regular Nasal Cannula
Sponsored by
RenJi Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypoxia focused on measuring the COMBO Endoscopy Oropharyngeal Airway, Hypoxia, Gastrointestinal Endoscopy, Propofol, Sedation

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • The First Affiliated Hospital with Nanjing Medical University
  • Shangdong Provincial Qianfoshan Hospital
  • Fudan University Shanghai Cancer Center
  • Renji Hospital
  • The First Affliated Hospital of Xi'an Jiangtong University
  • Tianjin Mediacal University General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

the COMBO Endoscopy Oropharyngeal Airway Group

Regular Nasal Cannula Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

The incidence of hypoxia
(75% ≤ SpO2 < 90% for <60 s)

Secondary Outcome Measures

The incidence of sub-clinical respiratory depression
(90% ≤ SpO2 < 95%)
The incidence of severe hypoxia
(SpO2 < 75% or 75% ≤ SpO2 < 90% for ≥60 s)

Full Information

First Posted
September 19, 2023
Last Updated
October 7, 2023
Sponsor
RenJi Hospital
Collaborators
Tianjin Medical University General Hospital, The First Affiliated Hospital with Nanjing Medical University, First Affiliated Hospital Xi'an Jiaotong University, Qianfoshan Hospital, Fudan University
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1. Study Identification

Unique Protocol Identification Number
NCT06081647
Brief Title
The Efficacy and Safety of the COMBO Endoscopy Oropharyngeal Airway in Gastrointestinal Endoscopy Procedure
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.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 9, 2023 (Anticipated)
Primary Completion Date
October 9, 2023 (Anticipated)
Study Completion Date
October 9, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
RenJi Hospital
Collaborators
Tianjin Medical University General Hospital, The First Affiliated Hospital with Nanjing Medical University, First Affiliated Hospital Xi'an Jiaotong University, Qianfoshan Hospital, Fudan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoxia, Gastric Polyp, Colon Cancer, Esophageal Cancer
Keywords
the COMBO Endoscopy Oropharyngeal Airway, Hypoxia, Gastrointestinal Endoscopy, Propofol, Sedation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
the COMBO Endoscopy Oropharyngeal Airway Group
Arm Type
Experimental
Arm Description
In this group, patients use the COMBO Endoscopy Oropharyngeal Airway for oxygenation.
Arm Title
Regular Nasal Cannula Group
Arm Type
Active Comparator
Arm Description
In this group, patients use the regular nasal cannula for oxygenation.
Intervention Type
Device
Intervention Name(s)
the COMBO Endoscopy Oropharyngeal Airway
Intervention Description
Using the COMBO Endoscopy Oropharyngeal Airway for oxygenation.
Intervention Type
Device
Intervention Name(s)
Regular Nasal Cannula
Intervention Description
Using regular nasal cannula for oxygenation.
Primary Outcome Measure Information:
Title
The incidence of hypoxia
Description
(75% ≤ SpO2 < 90% for <60 s)
Time Frame
Patients will be followed for the duration of hospital stay, an expected average about 2 hours
Secondary Outcome Measure Information:
Title
The incidence of sub-clinical respiratory depression
Description
(90% ≤ SpO2 < 95%)
Time Frame
Patients will be followed for the duration of hospital stay, an expected average about 2 hours
Title
The incidence of severe hypoxia
Description
(SpO2 < 75% or 75% ≤ SpO2 < 90% for ≥60 s)
Time Frame
Patients will be followed for the duration of hospital stay, an expected average about 2 hours
Other Pre-specified Outcome Measures:
Title
The incidence of other adverse events
Description
Other adverse events recorded by tools proposed by the World Society of Intravenous Anesthesia International Sedation Task Force
Time Frame
Patients will be followed for the duration of hospital stay, an expected average about 2 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Diansan Su, Dr.
Phone
+862168383702
Email
diansansu@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yuhan Zhang, B.S
Phone
+862168383702
Email
1092619255@qq.com
Facility Information:
Facility Name
The First Affiliated Hospital with Nanjing Medical University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cunming Liu, Dr.
Email
1335587409@qq.com
Facility Name
Shangdong Provincial Qianfoshan Hospital
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250014
Country
China
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Zhang, Dr.
Email
snapzhang@aliyun.com
Facility Name
Renji Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200127
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diansan Su, Dr.
Phone
+862168383702
Email
diansansu@yahoo.com
Facility Name
The First Affliated Hospital of Xi'an Jiangtong University
City
Xi'an
State/Province
Shanxi
ZIP/Postal Code
710061
Country
China
Facility Name
Tianjin Mediacal University General Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300052
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yonghao Yu, Dr.
Email
yuyonghao@126.com

12. IPD Sharing Statement

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

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