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 volunteersQualifiers
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
Single group
Treatments tested in this trial
wire-reinforced tracheal tube
DeviceSupraglottic oxygen therapy delivered via wire-reinforced nasotracheal tube
Treatment groups
Trial outcomes
Primary outcomes
The incidence of hypoxia(75% ≤ SpO2 < 90% for <60 s)
Secondary outcomes
The incidence of sub-clinical respiratory depression(90% ≤ SpO2 < 95%)
The incidence of severe hypoxia(SpO2 < 75% or 75% ≤ SpO2 < 90% for ≥60 s)
Other outcomes
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
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