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

Zhejiang University

Status: Enrolling

Conditions: Pulmonary Nodule; Hypoxia; Pulmonary Infection

Treatments: Device: wire-reinforced tracheal tube

Study type: Interventional

Funder types: Other

Identifiers

NCT07389083

ZJU2025C180

Details and patient eligibility

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Supraglottic oxygenation via nasotracheal catheterization Airway Group

Other group

Description:

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

Treatment:

Device: wire-reinforced tracheal tube