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

NCT06887335 | Recruiting

• 1 other identifier: 11-2025-013
• Study Type: observational
• Target: 203
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Diseases

Outcome Measures

Primary Outcomes (1)

• The incidence of hypoxia during deep sedation under proceduralist guidance with endotracheal intubation

  This study investigates the incidence of hypoxia during deep sedation under the proceduralist's guidance with endotracheal intubation. Hypoxia is defined as an oxygen saturation of less than 94% sustained for more than 10 seconds during the procedure.

  On the day of the bronchoscopy procedure, from the initiation of sedation therapy to the completion of the bronchoscopy procedure.

Secondary Outcomes (3)

• The incidence of severe hypoxia during deep sedation under proceduralist guidance with endotracheal intubation

  On the day of the bronchoscopy procedure, from the initiation of sedation therapy to the completion of the bronchoscopy procedure.

• The incidence of complications

  From the day of the bronchoscopy procedure to the outpatient visit one week after the procedure.

• The rate of patient satisfaction

  From the completion of the bronchoscopy procedure to the point when the patient has fully recovered from sedation.

Study Arms (1)

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

Procedure: Deep Sedation Under Proceduralist Direction with Pre-emptive Endotracheal Intubation

Interventions

Deep Sedation Under Proceduralist Direction with Pre-emptive Endotracheal Intubation 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

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

Eligibility Criteria

• Age: 19 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with pulmonary lesions

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pusan National University Yangsan Hospital: lead

Study Sites (1)

Pusan National University Yangsan Hospital

Yangsan, South Korea

RECRUITING

MeSH Terms

Conditions

Lung Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

• Hee Yun Seol, MD, PhD

  Pusan National University Yangsan Hospital, Yangsan, South Korea

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hee Yun Seol, MD, PhD

CONTACT

82-55-360-3854; seolhy@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Week
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor for fund

Study Record Dates

• First Submitted: March 14, 2025
• First Posted: March 20, 2025
• Study Start: April 8, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 31, 2025

Record last verified: 2025-05

Locations

KR (1)