Clinical trial NCT06081647: 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
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hypoxia
Gastric Polyp
Colon Cancer
Esophageal Cancer
Keywords: the COMBO Endoscopy Oropharyngeal Airway
Hypoxia
Gastrointestinal Endoscopy
Propofol
Sedation
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
Collaborators: name: Tianjin Medical University General Hospital
name: The First Affiliated Hospital with Nanjing Medical University
name: First Affiliated Hospital Xi'an Jiaotong University
name: Qianfoshan Hospital
name: Fudan University
First posted: 2023-10-13
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: The incidence of hypoxia
timeFrame: Patients will be followed for the duration of hospital stay, an expected average about 2 hours
Secondary outcomes:
measure: The incidence of sub-clinical respiratory depression
timeFrame: Patients will be followed for the duration of hospital stay, an expected average about 2 hours
measure: The incidence of severe hypoxia
timeFrame: Patients will be followed for the duration of hospital stay, an expected average about 2 hours
Other outcomes:
measure: The incidence of other adverse events
timeFrame: Patients will be followed for the duration of hospital stay, an expected average about 2 hours
Locations:
city: Nanjing
country: China
facility: The First Affiliated Hospital with Nanjing Medical University
state: Jiangsu
city: Jinan
country: China
facility: Shangdong Provincial Qianfoshan Hospital
state: Shandong
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
city: Shanghai
country: China
facility: Renji Hospital
state: Shanghai
city: Xi'an
country: China
facility: The First Affliated Hospital of Xi'an Jiangtong University
state: Shanxi
city: Tianjin
country: China
facility: Tianjin Mediacal University General Hospital
state: Tianjin
Study officials:
References: