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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFirst Affiliated Hospital of Zhejiang University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • wire-reinforced tracheal tube

    Device

    Supraglottic oxygen therapy delivered via wire-reinforced nasotracheal tube

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Supraglottic oxygenation via nasotracheal catheterization Airway GroupOther 1 intervention

Trial outcomes

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

Sponsors and contacts

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