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

The Efficacy and Safety of the Supraglottic Oxygenation Via Nasotracheal Intubation Reduce the Incidence of Hypoxia in Patients Undergoing Sedated Fiberoptic Bronchoscopy.

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.

Study Overview

• Status: Recruiting
• Conditions: Hypoxia; Pulmonary Nodule; Pulmonary Infection
• Intervention / Treatment: Device: wire-reinforced tracheal tube

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yeke Zhu; Phone Number: +8613515815457; Email: 21618018@zju.edu.cn
• Study Contact Backup: Name: Yueying Zheng; Phone Number: +8613777408863; Email: 1507128@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • Recruiting
      • The First Affiliated Hospital of Zhejiang University
      • Contact: Yeke Zhu; Phone Number: +8613515815457; Email: 21618018@zju.edu.cn
      • Contact: Email: 21618018@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Supraglottic oxygenation via nasotracheal catheterization Airway Group; In this group, patients received supraglottic oxygen therapy via nasotracheal intubation.	Device: wire-reinforced tracheal tube; Supraglottic oxygen therapy delivered via wire-reinforced nasotracheal tube

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The incidence of hypoxia（75% ≤ SpO2 < 90% for <60 s）	Periprocedural

Secondary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: First Affiliated Hospital of Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): December 28, 2025
• Primary Completion (Estimated): February 28, 2026
• Study Completion (Estimated): March 30, 2026

Study Registration Dates

• First Submitted: December 31, 2025
• First Submitted That Met QC Criteria: January 28, 2026
• First Posted (Actual): February 5, 2026

Study Record Updates

• Last Update Posted (Actual): February 5, 2026
• Last Update Submitted That Met QC Criteria: January 28, 2026
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Hypoxia; supine position; Deep sedation; fiberoptic bronchoscopy; tongue-base fallback; supraglottic oxygenation
• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory; Pathological Conditions, Signs and Symptoms; Behavior; Signs and Symptoms; Social Behavior; Hypoxia; Deception
• Other Study ID Numbers: ZJU2025C180

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No