Clinical trial NCT06887335: Deep Sedation With Pre-emptive Endotracheal Intubation for Advanced Bronchoscopy Procedures
Official title: An Observational Prospective Study on the Safety and Feasibility of Deep Sedation Under Proceduralist Direction With Pre-emptive Endotracheal Intubation for Advanced Bronchoscopy Procedures
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lung Diseases
Lead sponsor: Pusan National University Yangsan Hospital
Sponsor class: OTHER
First posted: 2025-03-20
Enrollment: 203
Sex: ALL
Minimum age (years): 19
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with pulmonary lesions

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.

Detailed 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.

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

Primary outcomes:
measure: 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.
Secondary outcomes:
measure: The incidence of severe 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.
measure: The incidence of complications
timeFrame: From the day of the bronchoscopy procedure to the outpatient visit one week after the procedure.
measure: The rate of patient satisfaction
timeFrame: From the completion of the bronchoscopy procedure to the point when the patient has fully recovered from sedation.
Other outcomes:
Locations:
city: Yangsan
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
Study officials:
affiliation: Pusan National University Yangsan Hospital, Yangsan, South Korea
name: Hee Yun Seol, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: