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Completed

NCT Number: NCT07063290

COMBO Endoscopy Oropharyngeal Airway in Sedated Fiberoptic Bronchoscopy for Patients: A Simon Two-Stage Trial

Hypoxia represents the prevailing adverse occurrence during the sedation of patients undergoing fiberoptic bronchoscopy 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 fiberoptic bronchoscopy under propofol sedation.

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Key information

Conditions

Pulmonary Infection Bronchial Diseases Bronchiectasis Endotracheal Tumour Hypoxia Pathological Conditions, Signs and Symptoms Pulmonary Nodule Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The First Affliated Hospital, Zhejiang University School Of Medicine

Hangzhou, Zhejiang, 310000, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 18≤ Age ≤70.·Patients undergoing fiberoptic bronchoscopy.
  • 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 with contraindications to oropharyngeal airway ventilation, such as coagulation disorders, predisposition to oral/nasal bleeding, mucosal damage, or anatomical obstructions hindering oropharyngeal airway placement.
  • Patients diagnosed with acute exacerbation of chronic obstructive pulmonary disease (COPD) or those currently suffering from other acute/chronic pulmonary conditions requiring long-term or intermittent oxygen therapy.
  • Patients with preoperative SpO₂ < 95% while breathing air.
  • Patients with BMI < 18.5 or BMI > 30.
  • Patients with upper respiratory tract infections (oral, nasal, or pharyngeal).
  • Patients at risk of aspiration.
  • Patients with fever (core temperature > 37.5°C).
  • Patients with severe cardiac insufficiency (< 4 METs).
  • Patients with severe renal insufficiency requiring preoperative dialysis.
  • Patients with a confirmed diagnosis of hepatic insufficiency.
  • Patients with increased intracranial pressure.
  • Patients with hypersensitivity to sedatives like propofol or medical equipment such as adhesive tape.
  • Patients with a history of drug abuse and/or alcoholism within the two years preceding the commencement of the screening period (defined as drinking 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.
  • Patients currently participating in other clinical trials.
  • Patients deemed ineligible for participation in this clinical trial by the researchers.

Treatment and study plan

the COMBO Endoscopy Oropharyngeal Airway

Device

Using the COMBO Endoscopy Oropharyngeal Airway for oxygenation.

Primary outcomes

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

    Time frame: Patients are continuously monitored from the beginning of anesthesia induction until exiting the PACU (Post-Anesthesia Care Unit).

Secondary outcomes

  1. The incidence of sub-clinical respiratory depression（90% ≤ SpO2 < 95%）

    Time frame: Patients are continuously monitored from the beginning of anesthesia induction until exiting the PACU (Post-Anesthesia Care Unit).

  2. The incidence of severe hypoxia（SpO2 < 75% or 75% ≤ SpO2 < 90% for ≥60 s）

    Time frame: Patients are continuously monitored from the beginning of anesthesia induction until exiting the PACU (Post-Anesthesia Care Unit).

Other outcomes

  1. The incidence of other adverse events

    Time frame: Patients are continuously monitored from the beginning of anesthesia induction until exiting the PACU (Post-Anesthesia Care Unit).

    Other adverse events recorded by tools proposed by the World Society of Intravenous Anesthesia International Sedation Task Force

Sponsors and collaborators

Lead sponsor

Zhejiang University

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 14, 2025
Registry last updated
Feb 24, 2026

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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