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

NCT07063290 | Completed Phase 2

• 1 other identifier: ZJU2025B0779
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Endotracheal Tumour; Bronchiectasis; Pulmonary Infection; Pulmonary Nodule

Keywords

the COMBO Endoscopy Oropharyngeal Airway; fiberoptic bronchoscopy; hypoxia

Outcome Measures

Primary Outcomes (1)

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

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

Secondary Outcomes (2)

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

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

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

  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

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

Study Arms (1)

the COMBO Endoscopy Oropharyngeal Airway Group

OTHER

In this group, patients use the COMBO Endoscopy Oropharyngeal Airway for oxygenation.

Device: the COMBO Endoscopy Oropharyngeal Airway

Interventions

the COMBO Endoscopy Oropharyngeal Airway DEVICE

Using the COMBO Endoscopy Oropharyngeal Airway for oxygenation.

the COMBO Endoscopy Oropharyngeal Airway Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhejiang University: lead

Study Sites (1)

The First Affliated Hospital, Zhejiang University School Of Medicine

Hangzhou, Zhejiang, 310000, China

Location

MeSH Terms

Conditions

Bronchiectasis; Hypoxia

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chair of Anesthesiology Department

Model Details: The COMBO Endoscopy Oropharyngeal Airway integrates a bite block, capnography monitoring, oxygenation support, and an innovative oropharyngeal airway design. The COMBO device is a novel airway management device with integrated capnography monitoring and dual oxygenation support. It was developed to overcome persistent challenges in maintaining airway patency and oxygenation during bronchoscopy under sedation.

Study Record Dates

• First Submitted: June 29, 2025
• First Posted: July 14, 2025
• Study Start: June 23, 2025
• Primary Completion: September 18, 2025
• Study Completion: September 18, 2025
• Last Updated: February 24, 2026

Record last verified: 2026-02

Locations

CN (1)