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Recruiting NCT07389083

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

No phase Interventional Hypoxia Pulmonary Nodule Pulmonary Infection

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: wire-reinforced tracheal tube.
Who it may be relevant to
Registry conditions: Hypoxia, Pulmonary Nodule, Pulmonary Infection. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Device wire-reinforced tracheal tube
    Supraglottic oxygen therapy delivered via wire-reinforced nasotracheal tube

Primary outcome measures

  • The incidence of hypoxia（75% ≤ SpO2 < 90% for <60 s） [Time frame: Periprocedural]
Secondary outcome measures (2)
  • The incidence of sub-clinical respiratory depression(90% ≤ SpO2 < 95%) [Time frame: Periprocedural]
  • The incidence of severe hypoxia(SpO2 < 75% or 75% ≤ SpO2 < 90% for ≥60 s) [Time frame: Periprocedural]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Prevention

Study locations

China · 1 center
  • The First Affiliated Hospital of Zhejiang University — Hangzhou

Identifiers

NCT: NCT07389083 · ZJU2025C180

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗