Trial Title:
The Efficacy and Safety of the COMBO Endoscopy Oropharyngeal Airway in Gastrointestinal Endoscopy Procedure
NCT ID:
NCT06081647
Condition:
Hypoxia
Gastric Polyp
Colon Cancer
Esophageal Cancer
Conditions: Official terms:
Hypoxia
Conditions: Keywords:
the COMBO Endoscopy Oropharyngeal Airway
Hypoxia
Gastrointestinal Endoscopy
Propofol
Sedation
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Prevention
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
the COMBO Endoscopy Oropharyngeal Airway
Description:
Using the COMBO Endoscopy Oropharyngeal Airway for oxygenation.
Arm group label:
the COMBO Endoscopy Oropharyngeal Airway Group
Intervention type:
Device
Intervention name:
Regular Nasal Cannula
Description:
Using regular nasal cannula for oxygenation.
Arm group label:
Regular Nasal Cannula Group
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
60 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
The First Affiliated Hospital with Nanjing Medical University
Address:
City:
Nanjing
Zip:
210029
Country:
China
Contact:
Last name:
Cunming Liu, Dr.
Email:
1335587409@qq.com
Facility:
Name:
Shangdong Provincial Qianfoshan Hospital
Address:
City:
Jinan
Zip:
250014
Country:
China
Facility:
Name:
Fudan University Shanghai Cancer Center
Address:
City:
Shanghai
Zip:
200032
Country:
China
Contact:
Last name:
Jun Zhang, Dr.
Email:
snapzhang@aliyun.com
Facility:
Name:
Renji Hospital
Address:
City:
Shanghai
Zip:
200127
Country:
China
Contact:
Last name:
Diansan Su, Dr.
Phone:
+862168383702
Email:
diansansu@yahoo.com
Facility:
Name:
The First Affliated Hospital of Xi'an Jiangtong University
Address:
City:
Xi'an
Zip:
710061
Country:
China
Facility:
Name:
Tianjin Mediacal University General Hospital
Address:
City:
Tianjin
Zip:
300052
Country:
China
Contact:
Last name:
Yonghao Yu, Dr.
Email:
yuyonghao@126.com
Start date:
October 9, 2023
Completion date:
October 9, 2024
Lead sponsor:
Agency:
RenJi Hospital
Agency class:
Other
Collaborator:
Agency:
Tianjin Medical University General Hospital
Agency class:
Other
Collaborator:
Agency:
The First Affiliated Hospital with Nanjing Medical University
Agency class:
Other
Collaborator:
Agency:
First Affiliated Hospital Xi'an Jiaotong University
Agency class:
Other
Collaborator:
Agency:
Qianfoshan Hospital
Agency class:
Other
Collaborator:
Agency:
Fudan University
Agency class:
Other
Source:
RenJi Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06081647
