Supraglottic oxygen through a thin nasal tube during deep-sedation bronchoscopy
The Efficacy and Safety of the Supraglottic Oxygenation Via Nasotracheal Intubation Reduce the Incidence of Hypoxia in Patients Undergoing Sedated Fiberoptic Bronchoscopy.
This trial tests whether inserting a thin, wired endotracheal tube through the nose to deliver oxygen above the vocal cords helps prevent low oxygen levels in adults undergoing deep-sedation fiberoptic bronchoscopy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | First Affiliated Hospital of Zhejiang University Academic / other |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT07389083 on ClinicalTrials.gov |
What this trial studies
Bronchoscopy under deep sedation can cause the tongue base to fall back and obstruct the airway, increasing the risk of hypoxia. This single-center interventional trial uses a wire-reinforced tracheal tube (size 4.0 or 4.5) placed nasally to provide direct supraglottic oxygenation and partly relieve airway obstruction while allowing connection to an oxygen line or ventilator circuit. Eligible adult patients undergoing fiberoptic bronchoscopy under deep sedation are enrolled with standard exclusion criteria such as BMI >30, anticipated difficult airway, recent nasal/sinus surgery, or active upper respiratory infection. The study measures feasibility and safety outcomes including oxygenation metrics, hypoxic events, and procedure-related complications.
Who should consider this trial
Good fit: Adults scheduled for fiberoptic bronchoscopy under deep sedation who can give informed consent and do not meet exclusion criteria such as BMI >30, anticipated difficult airway, or active upper-airway infection.
Not a fit: Patients with BMI over 30, anticipated difficult airways, recent nasal or sinus surgery, active upper respiratory infection, severe organ failure, or baseline room-air oxygen saturation below 92% are excluded and unlikely to benefit from this approach.
Why it matters
Potential benefit: If successful, this technique could reduce episodes of low oxygen during sedated bronchoscopy and make the procedure safer and more comfortable for patients.
How similar studies have performed: Related work supports supraglottic oxygenation and use of naso/oropharyngeal airways to reduce hypoxia, but using a wired nasotracheal tube specifically for this purpose is relatively novel and less extensively studied.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Hangzhou, Zhejiang
- The First Affiliated Hospital of Zhejiang University — Hangzhou, Zhejiang, China (Recruiting)
Study contacts
- Study coordinator: Yueying Zheng
- Email: 1507128@zju.edu.cn
- Phone: +8613777408863
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.