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

NCT ID: NCT06887335

Last Updated: 2025-05-31

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 203 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-04-08
• Study Completion Date: 2026-12-31

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.

Conditions

Lung Diseases

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients requiring a bronchoscopy-assisted procedure for diagnostic or therapeutic purposes

Deep Sedation Under Proceduralist Direction with Pre-emptive Endotracheal Intubation

Intervention Type: PROCEDURE

If an eligible subject consents to participate in the study, deep sedation and preemptive endotracheal intubation will be performed, followed by bronchoscopy. Deep sedation will be administered according to the study protocol, with final approval of sedative administration given by the proceduralist. Oxygen will be supplied at a flow rate of 4-6 L/min via a nasal cannula before sedative administration.

To achieve a deep sedation state (Modified Observer's Assessment of Alertness/Sedation [MOAA/S] score ≤ 2, defined as the patient not opening their eyes despite repeated verbal stimuli), an initial dose of 50 mcg fentanyl will be administered, followed by 2.5-5 mg of remimazolam. The sedation depth will be assessed every two minutes using the MOAA/S score. If the patient has not reached deep sedation, an additional 2.5 mg of remimazolam will be administered.

Once deep sedation is achieved, lidocaine will be sprayed onto the trachea and bronchi using a bronchoscope for local anesthe

Interventions

Deep Sedation Under Proceduralist Direction with Pre-emptive Endotracheal Intubation

If an eligible subject consents to participate in the study, deep sedation and preemptive endotracheal intubation will be performed, followed by bronchoscopy. Deep sedation will be administered according to the study protocol, with final approval of sedative administration given by the proceduralist. Oxygen will be supplied at a flow rate of 4-6 L/min via a nasal cannula before sedative administration.

To achieve a deep sedation state (Modified Observer's Assessment of Alertness/Sedation [MOAA/S] score ≤ 2, defined as the patient not opening their eyes despite repeated verbal stimuli), an initial dose of 50 mcg fentanyl will be administered, followed by 2.5-5 mg of remimazolam. The sedation depth will be assessed every two minutes using the MOAA/S score. If the patient has not reached deep sedation, an additional 2.5 mg of remimazolam will be administered.

Once deep sedation is achieved, lidocaine will be sprayed onto the trachea and bronchi using a bronchoscope for local anesthe

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pusan National University Yangsan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Hee Yun Seol

Assistant professor for fund

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hee Yun Seol, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Pusan National University Yangsan Hospital, Yangsan, South Korea

Locations

Pusan National University Yangsan Hospital

Yangsan, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Hee Yun Seol, MD, PhD

Role: CONTACT

seolhy@hotmail.com

82-55-360-3854

Facility Contacts

Hee Yun Seol, MD, PhD

Role: primary

seolhy@hotmail.com

82-55-360-3854

Other Identifiers

11-2025-013

Identifier Type: -

Identifier Source: org_study_id