Actively Recruiting
The Efficacy and Safety of the Supraglottic Oxygenation Via Nasotracheal Intubation Reduce the Incidence of Hypoxia in Patients Undergoing Sedated Fiberoptic Bronchoscopy
Led by First Affiliated Hospital of Zhejiang University · Updated on 2026-02-05
50
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying a new way to deliver oxygen during deep sedation for fiberoptic bronchoscopy, a procedure used to diagnose and treat lung conditions like hypoxia, pulmonary nodules, and infections. The study focuses on improving patient comfort and safety by testing a modified oxygen delivery method using a wire-reinforced nasotracheal tube. This device aims to reduce the risk of low oxygen levels during the procedure, which is common due to airway obstruction and stress responses. Participants in the study receive supraglottic oxygen therapy through a thin, wire-reinforced endotracheal tube inserted through the nose. This tube connects easily to an oxygen supply and helps keep the airway open, allowing better oxygen flow during sedation. The study evaluates how well this method works and how safe it is for patients during bronchoscopy. During the procedure, researchers monitor oxygen levels closely to detect hypoxia or respiratory depression. They measure the incidence of low oxygen saturation, including severe cases, throughout the bronchoscopy. Participants' safety and response to the oxygen delivery method are assessed, and the study collects detailed data on oxygen levels during sedation. The trial runs until March 2026 and involves ongoing observation of the procedure's effects on breathing and oxygenation.
CONDITIONS
Brief Title
The Efficacy and Safety of the Supraglottic Oxygenation Via Nasotracheal Intubation for Deep Sedation Fiberoptic Bronchoscopy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Undergoing fiberoptic bronchoscopy under deep sedation.
- Written informed consent obtained from the patient or their legal representative.
- Clear understanding of, and voluntary participation in, the study, with informed-consent form signed by the patient or their legal representative.
You will not qualify if you...
- Age less than 18 years.
- Body mass index (BMI) over 30 kg/m².
- Previous history of abnormal recovery from anesthesia or surgery.
- History of recurrent nosebleeds, nasal bone fracture, nasal polyps, or sinus surgery.
- Chronic use of opioid analgesics, benzodiazepine hypnotics, or antidepressant medications.
- Known allergy to any of the anesthetic agents used.
- Anticipated difficult airway.
- Increased intracranial pressure.
- Active upper-respiratory-tract infection of the oral, nasal, or pharyngeal regions.
- Severe cardiac insufficiency with functional capacity less than 4 METs.
- Severe renal failure requiring dialysis before surgery.
- Pre-operative oxygen saturation on room air less than 92%.
- Any condition that makes the patient unsuitable for participation as judged by the investigator.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - During the fiberoptic bronchoscopy procedure
Participants receive supraglottic oxygen therapy via wire-reinforced nasotracheal intubation during deep sedation fiberoptic bronchoscopy.
1 procedure visit (in-person)
Duration - Periprocedural period
Participants are observed for the incidence of hypoxia and respiratory depression following the procedure.
1 follow-up visit (in-person)
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, China, 310000
Actively Recruiting
Research Team
Y
Yueying Zheng
Y
Yeke Zhu
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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