Deep Sedation With Pre-emptive Endotracheal Intubation for Advanced Bronchoscopy Procedures (NCT06887335) | Clinical Trial Compass
RecruitingNot Applicable
Deep Sedation With Pre-emptive Endotracheal Intubation for Advanced Bronchoscopy Procedures
South Korea203 participantsStarted 2025-04-08
Plain-language 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.
Who can participate
Age range
19 Years – 90 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The incidence of hypoxia during deep sedation under proceduralist guidance with endotracheal intubation
Timeframe: On the day of the bronchoscopy procedure, from the initiation of sedation therapy to the completion of the bronchoscopy procedure.