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NCT Number: NCT06081647

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

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.

Recruiting

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Affiliated Hospital with Nanjing Medical University, Nanjing, Jiangsu, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

the COMBO Endoscopy Oropharyngeal Airway

Device

Using the COMBO Endoscopy Oropharyngeal Airway for oxygenation.

Regular Nasal Cannula

Device

Using regular nasal cannula for oxygenation.

Primary outcomes

  1. The incidence of hypoxia

    Time frame: Patients will be followed for the duration of hospital stay, an expected average about 2 hours

    (75% ≤ SpO2 < 90% for <60 s)

Secondary outcomes

  1. The incidence of sub-clinical respiratory depression

    Time frame: Patients will be followed for the duration of hospital stay, an expected average about 2 hours

    (90% ≤ SpO2 < 95%)

  2. The incidence of severe hypoxia

    Time frame: 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 outcomes

  1. The incidence of other adverse events

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Diansan Su, Dr.

CONTACT

[email protected]

+862168383702

Yuhan Zhang, B.S

CONTACT

[email protected]

+862168383702

Sponsors and collaborators

Lead sponsor

RenJi Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Oct 13, 2023
Registry last updated
Jun 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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