Preemptive endotracheal intubation with deep sedation for advanced bronchoscopy
An Observational Prospective Study on the Safety and Feasibility of Deep Sedation Under Proceduralist Direction With Pre-emptive Endotracheal Intubation for Advanced Bronchoscopy Procedures
We will test whether using preemptive endotracheal intubation during deep sedation makes advanced bronchoscopy safer and easier for patients undergoing complex bronchoscopic procedures.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 203 (estimated) |
| Ages | 19 Years to 90 Years |
| Sex | All |
| Sponsor | Pusan National University Yangsan Hospital Academic / other |
| Locations | 1 site (Yangsan) |
| Trial ID | NCT06887335 on ClinicalTrials.gov |
What this trial studies
Bronchoscopy under deep sedation can improve patient comfort and procedural efficiency but increases the risk of respiratory depression and airway obstruction that may require urgent intubation. To reduce interruptions and emergency airway interventions, the investigator routinely performs preemptive endotracheal intubation before complex bronchoscopic procedures. This is a multicenter prospective observational study enrolling patients scheduled for diagnostic or therapeutic bronchoscopy to document safety, feasibility, procedural completion, and complications using that approach. Study data will include airway events, unplanned interventions, procedure success rates, and short-term patient outcomes.
Who should consider this trial
Good fit: Adults who require diagnostic or therapeutic bronchoscopy for complex or prolonged procedures, can provide informed consent, and do not meet exclusion criteria are the intended participants.
Not a fit: Patients with contraindications to bronchoscopy or to the sedatives used, recent acute myocardial infarction or stroke, pregnant women, prisoners, those with certain genetic or drug allergies, psychiatric disorders, or ASA IV–V status are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, this approach could reduce emergency airway events, increase completion rates for complex bronchoscopies, and improve patient comfort during procedures.
How similar studies have performed: The investigator has reported years of institutional experience and shared the technique regionally, but the published evidence is limited to observational series rather than randomized trials.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients requiring a bronchoscopy-assisted procedure for diagnostic or therapeutic purposes * Individuals who voluntarily consent to participate in the clinical study and sign a written informed consent form Exclusion Criteria: * Patients who have experienced acute myocardial infarction or acute stroke within the past six weeks * Patients with contraindications to bronchoscopy (e.g., severe respiratory or cardiovascular comorbidities) * Patients with a history of allergy to benzodiazepines, propofol, fentanyl, or flumazenil * Patients with genetic disorders such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption * Patients with a severe hypersensitivity reaction to dextran 40 * Patients with a history of acute angle-closure glaucoma * Pregnant women * Prisoners * Patients with psychiatric disorders * Patients classified as ASA Physical Status IV or V by the American Society of Anesthesiologists (ASA) * Any other patients deemed unsuitable for the clinical study by the investigator
Where this trial is running
Yangsan
- Pusan National University Yangsan Hospital — Yangsan, South Korea (Recruiting)
Study contacts
- Principal investigator: Hee Yun Seol, MD, PhD — Pusan National University Yangsan Hospital, Yangsan, South Korea
- Study coordinator: Hee Yun Seol, MD, PhD
- Email: seolhy@hotmail.com
- Phone: 82-55-360-3854
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.