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NCT Number: NCT07389083

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

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Key information

Conditions

Hypoxia Behavior Deception Pathological Conditions, Signs and Symptoms Pulmonary Infection Pulmonary Nodule Signs and Symptoms Signs and Symptoms, Respiratory Social Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

wire-reinforced tracheal tube

Device

Supraglottic oxygen therapy delivered via wire-reinforced nasotracheal tube

Primary outcomes

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

    Time frame: Periprocedural

Secondary outcomes

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

    Time frame: Periprocedural

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

    Time frame: 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

    Time frame: peri-anesthetic period

Study contacts

Contact information is provided by the study sponsor or research team.

Yeke Zhu

CONTACT

[email protected]

+8613515815457

Yueying Zheng

CONTACT

[email protected]

+8613777408863

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Zhejiang University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 5, 2026
Registry last updated
Feb 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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