NCT07389083 The Efficacy and Safety of the Supraglottic Oxygenation Via Nasotracheal Intubation for Deep Sedation Fiberoptic Bronchoscopy
| NCT ID | NCT07389083 |
| Status | Recruiting |
| Phase | — |
| Sponsor | First Affiliated Hospital of Zhejiang University |
| Condition | Hypoxia |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2025-12-28 |
| Primary Completion | 2026-02-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2025-12-28 with a primary completion date of 2026-02-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07389083 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hypoxia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07389083 currently recruiting?
Yes, NCT07389083 is actively recruiting participants. Contact the research team at 1507128@zju.edu.cn for enrollment information.
Where is the NCT07389083 trial being conducted?
This trial is being conducted at Hangzhou, China.
Who is sponsoring the NCT07389083 clinical trial?
NCT07389083 is sponsored by First Affiliated Hospital of Zhejiang University. The trial plans to enroll 50 participants.