NCT06887335 Deep Sedation With Pre-emptive Endotracheal Intubation for Advanced Bronchoscopy Procedures
| NCT ID | NCT06887335 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Pusan National University Yangsan Hospital |
| Condition | Lung Diseases |
| Study Type | OBSERVATIONAL |
| Enrollment | 203 participants |
| Start Date | 2025-04-08 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 203 participants in total. It began in 2025-04-08 with a primary completion date of 2026-12-31.
⚠ 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 crucial for diagnosing and treating respiratory diseases and is recommended under sedation. Deep sedation improves patient comfort and procedural efficiency, especially in complex cases, by reducing movement and coughing. However, it carries risks of respiratory depression and airway obstruction, potentially requiring premature termination or urgent intubation. Determining the optimal timing for intubation can be challenging despite proper monitoring. To enhance safety, the investigator has performed bronchoscopy under deep sedation with preemptive intubation for years, sharing this experience with other hospitals. This study aims to evaluate its safety and feasibility through a multicenter prospective observational approach.
Eligibility 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
Contact & Investigator
Hee Yun Seol, MD, PhD
PRINCIPAL INVESTIGATOR
Pusan National University Yangsan Hospital, Yangsan, South Korea
Frequently Asked Questions
Who can join the NCT06887335 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, up to 90 Years, studying Lung Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06887335 currently recruiting?
Yes, NCT06887335 is actively recruiting participants. Contact the research team at seolhy@hotmail.com for enrollment information.
Where is the NCT06887335 trial being conducted?
This trial is being conducted at Yangsan, South Korea.
Who is sponsoring the NCT06887335 clinical trial?
NCT06887335 is sponsored by Pusan National University Yangsan Hospital. The principal investigator is Hee Yun Seol, MD, PhD at Pusan National University Yangsan Hospital, Yangsan, South Korea. The trial plans to enroll 203 participants.