Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07389083

The Efficacy and Safety of the Supraglottic Oxygenation Via Nasotracheal Intubation for Deep Sedation Fiberoptic Bronchoscopy

Led by First Affiliated Hospital of Zhejiang University · Updated on 2026-02-05

50

Participants Needed

1

Research Sites

13 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Bronchoscopy is now widely used for the diagnosis and treatment of various respiratory diseases. However, the procedure is highly stimulating and provokes a strong stress response; because the airway is shared, patients are prone to hypoxia. With the growing emphasis on comfortable care, demand for anesthesia during bronchoscopy has increased. Deep sedation is the most common approach, but when administered in the supine position it often causes the tongue base to fall back. Both nasopharyngeal and oropharyngeal airways can relieve this obstruction, yet neither connects seamlessly to an oxygen supply line, resulting in insufficient oxygen delivery.We therefore replaced the nasopharyngeal airway with a wired endotracheal tube (size 4.0 or 4.5) inserted via the nose. This thinner tube couples easily to an oxygen line or ventilator circuit, partially relieves airway obstruction, and allows ample supraglottic oxygenation. The present study was designed to evaluate the feasibility and safety of this modified oxygen-delivery method in patients undergoing deep sedation for bronchoscopy.

CONDITIONS

Official Title

The Efficacy and Safety of the Supraglottic Oxygenation Via Nasotracheal Intubation for Deep Sedation Fiberoptic Bronchoscopy

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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.
Not Eligible

You will not qualify if you...

  • Age under 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 anesthetic agents used.
  • Anticipated difficult airway.
  • Increased intracranial pressure.
  • Active upper respiratory infection in the oral, nasal, or pharyngeal areas.
  • Severe heart failure with functional capacity less than 4 METs.
  • Severe kidney failure requiring dialysis before surgery.
  • Pre-operative oxygen saturation on room air below 92%.
  • Any condition that makes the patient unsuitable for the trial according to the investigator.

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

The First Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, China, 310000

Actively Recruiting

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Research Team

Y

Yueying Zheng

CONTACT

Y

Yeke Zhu

CONTACT

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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