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

NCT ID: NCT07063290

Last Updated: 2025-07-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-16
• Study Completion Date: 2026-03-31

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

Pulmonary Infection; Pulmonary Nodule; Endotracheal Tumour; Bronchiectasis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

the COMBO Endoscopy Oropharyngeal Airway Group

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

Group Type: OTHER

the COMBO Endoscopy Oropharyngeal Airway

Intervention Type: DEVICE

Using the COMBO Endoscopy Oropharyngeal Airway for oxygenation.

Interventions

the COMBO Endoscopy Oropharyngeal Airway

Using the COMBO Endoscopy Oropharyngeal Airway for oxygenation.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Age 18≤ Age ≤60.·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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Diansan Su

chair of Anesthesiology Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The First Affliated Hospital, Zhejiang University School Of Medicine

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Diansan Su

Role: CONTACT

diansansu@yahoo.com

+8618616514088

Yeke Zhu

Role: CONTACT

21618018@zju.edu.cn

+8613515815457

Facility Contacts

Role: primary

zyiitlunli@163.com

0571-87233418

Other Identifiers

ZJU2025B0779

Identifier Type: -

Identifier Source: org_study_id