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

NCT07389083 | Recruiting

• 1 other identifier: ZJU2025C180
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Hypoxia; Pulmonary Nodule; Pulmonary Infection

Keywords

fiberoptic bronchoscopy; Hypoxia; Deep sedation; supine position; tongue-base fallback; supraglottic oxygenation

Outcome Measures

Primary Outcomes (1)

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

  Periprocedural

Secondary Outcomes (2)

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

  Periprocedural

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

  Periprocedural

Other Outcomes (1)

• To observe the incidence of adverse events according to the document from the World SIVA International Sedation Task Force(doi:10.1093/bja/aer407) in patients undergoing bronchoscopy under deep sedation

  peri-anesthetic period

Study Arms (1)

Supraglottic oxygenation via nasotracheal catheterization Airway Group

OTHER

In this group, patients received supraglottic oxygen therapy via nasotracheal intubation.

Device: wire-reinforced tracheal tube

Interventions

wire-reinforced tracheal tube DEVICE

Supraglottic oxygen therapy delivered via wire-reinforced nasotracheal tube

Supraglottic oxygenation via nasotracheal catheterization Airway Group

Eligibility Criteria

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

You may qualify if:

• 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 may not qualify if:

• Age \< 18 years
• BMI \> 30 kg/m²
• Previous history of abnormal recovery from anesthesia/surgery
• History of recurrent epistaxis, 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 employed
• Anticipated difficult airway
• Increased intracranial pressure
• Active upper-respiratory-tract infection of the oral, nasal, or pharyngeal regions
• Severe cardiac insufficiency (functional capacity \< 4 METs)
• Severe renal failure requiring dialysis prior to surgery
• Pre-operative oxygen saturation on room air \< 92 %
• Any condition that, in the opinion of the investigator, renders the patient unsuitable for participation in this trial

Sponsors & Collaborators

• First Affiliated Hospital of Zhejiang University: lead

Study Sites (1)

The First Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, 310000, China

RECRUITING

MeSH Terms

Conditions

Hypoxia; Deception

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Social Behavior; Behavior

Central Study Contacts

Yueying Zheng

CONTACT

+8613777408863; 1507128@zju.edu.cn

Yeke Zhu

CONTACT

+8613515815457; 21618018@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Director of the Anesthesiology Department

Study Record Dates

• First Submitted: December 31, 2025
• First Posted: February 5, 2026
• Study Start: December 28, 2025
• Primary Completion: February 28, 2026
• Study Completion: March 30, 2026
• Last Updated: February 5, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

CN (1)