Deep Sedation With Pre-emptive Endotracheal Intubation for Advanced Bronchoscopy Procedures

Phase

N/A

Condition

N/A

Treatment

Deep Sedation Under Proceduralist Direction with Pre-emptive Endotracheal Intubation

Clinical Study ID

NCT06887335

11-2025-013

Ages 19-90
All Genders

Study 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

Inclusion Criteria:

Patients requiring a bronchoscopy-assisted procedure for diagnostic or therapeuticpurposes
Individuals who voluntarily consent to participate in the clinical study and sign awritten informed consent form

Exclusion

Exclusion Criteria:

Patients who have experienced acute myocardial infarction or acute stroke within thepast six weeks
Patients with contraindications to bronchoscopy (e.g., severe respiratory orcardiovascular comorbidities)
Patients with a history of allergy to benzodiazepines, propofol, fentanyl, orflumazenil
Patients with genetic disorders such as galactose intolerance, Lapp lactasedeficiency, 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 ofAnesthesiologists (ASA)
Any other patients deemed unsuitable for the clinical study by the investigator

Study Design

Deep Sedation Under Proceduralist Direction with Pre-emptive Endotracheal Intubation

April 08, 2025

December 31, 2026

Study Description

Bronchoscopy is a crucial procedure for diagnosing and treating respiratory diseases. It is recommended to be performed under sedation whenever possible, with sedation levels ranging from minimal to moderate and deep sedation. Deep sedation enhances patient comfort and facilitates the procedure, making it particularly useful for lengthy or complex bronchoscopic examinations. Additionally, deep sedation reduces involuntary patient movements and coughing, allowing the proceduralist to perform bronchoscopy more effectively when the patient is deeply sedated.

Despite its benefits, deep sedation carries the risk of respiratory depression and impaired airway maintenance, which may necessitate early termination of the bronchoscopy. If respiratory suppression or inadequate airway maintenance occurs during deep sedation, the procedure may need to be interrupted for endotracheal intubation using the bronchoscope. However, even with appropriate monitoring during bronchoscopy, determining the optimal timing for endotracheal intubation can be challenging, potentially disrupting procedural continuity and reducing the likelihood of a successful examination.

To enhance patient comfort and procedural safety, the investigator has been performing bronchoscopy under deep sedation with preemptive endotracheal intubation for several years. This clinical experience has been shared with other university hospitals in the region, and cases of deep sedation with preemptive intubation under the supervision of bronchoscopists have been reported. This study aims to evaluate the safety and feasibility of deep sedation with preemptive endotracheal intubation during bronchoscopy through a multicenter prospective observational approach.

Connect with a study center

Pusan National University Yangsan Hospital
Yangsan,
Korea, Republic of
Active - Recruiting

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