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

Esophageal Cancer Clinical Trial

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06081647
• Other study ID #: LY2023-159-B
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 9, 2023
• Est. completion date: October 9, 2024

Study information

• Verified date: October 2023
• Source: RenJi Hospital
• Contact: Diansan Su, Dr.
• Phone: +862168383702
• Email: diansansu[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1200
• Est. completion date: October 9, 2024
• Est. primary completion date: October 9, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colon Cancer
• Esophageal Cancer
• Gastric Polyp
• Hypoxia

Intervention

Device:
• the COMBO Endoscopy Oropharyngeal Airway
Using the COMBO Endoscopy Oropharyngeal Airway for oxygenation.
• Regular Nasal Cannula
Using regular nasal cannula for oxygenation.

Locations

Country	Name	City	State
China	Shangdong Provincial Qianfoshan Hospital	Jinan	Shandong
China	The First Affiliated Hospital with Nanjing Medical University	Nanjing	Jiangsu
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai
China	Renji Hospital	Shanghai	Shanghai
China	Tianjin Mediacal University General Hospital	Tianjin	Tianjin
China	The First Affliated Hospital of Xi'an Jiangtong University	Xi'an	Shanxi

Sponsors (6)

Lead Sponsor	Collaborator
RenJi Hospital	First Affiliated Hospital Xi'an Jiaotong University, Fudan University, Qianfoshan Hospital, The First Affiliated Hospital with Nanjing Medical University, Tianjin Medical University General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The incidence of other adverse events	Other adverse events recorded by tools proposed by the World Society of Intravenous Anesthesia International Sedation Task Force	Patients will be followed for the duration of hospital stay, an expected average about 2 hours
Primary	The incidence of hypoxia	(75% = SpO2 < 90% for <60 s)	Patients will be followed for the duration of hospital stay, an expected average about 2 hours
Secondary	The incidence of sub-clinical respiratory depression	(90% = SpO2 < 95%)	Patients will be followed for the duration of hospital stay, an expected average about 2 hours
Secondary	The incidence of severe hypoxia	(SpO2 < 75% or 75% = SpO2 < 90% for =60 s)	Patients will be followed for the duration of hospital stay, an expected average about 2 hours