Lung DiseasesNCT06887335
Deep Sedation With Pre-emptive Endotracheal Intubation for Advanced Bronchoscopy Procedures
An observational study of Lung Diseases, run by Pusan National University Yangsan Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 90 years
- Conditions the study is for
- Lung Diseases
- What is being tested?
- Deep Sedation Under Proceduralist Direction with Pre-emptive Endotracheal Intubation
- Type of treatment
- Surgery or procedure
- How many people
- 191 participants
- Where
- 1 siteSouth Korea
- Study dates
- 8 Apr 2025to 31 Mar 2026
- How long will I take part?
- 1 Week
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with pulmonary lesions
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Being tested
- Deep Sedation Under Proceduralist Direction with Pre-emptive Endotracheal Intubation
- Medical subject headings
- Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep Sedation Under Proceduralist Direction with Pre-emptive Endotracheal IntubationProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Patients requiring a bronchoscopy-assisted procedure for diagnostic or therapeutic purposes | Not described Receives: Procedure: Deep Sedation Under Proceduralist Direction with Pre-emptive Endotracheal Intubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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 90% sustained for more than 60 seconds during the procedure.
Measured: On the day of the bronchoscopy procedure, from the initiation of sedation therapy to the completion of the bronchoscopy procedure.
The incidence of complications
early termination or delay of the procedure, complications from endotracheal intubation, complications from bronchoscopy
Measured: From the day of the bronchoscopy procedure to the outpatient visit one week after the procedure.
The rate of patient satisfaction
Patient satisfaction immediately after the procedure is assessed by two items: distress during fiberoptic bronchoscopy (distress/ tolerable/ no distress or satisfied) and willingness to be reexamined (accept/ never again).
Measured: From the completion of the bronchoscopy procedure to the point when the patient has fully recovered from sedation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2025
- Study start8 Apr 2025
- Primary completion31 Mar 2026
- Study completion31 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 191 participants (actual)
- Target duration
- 1 Week
Sponsor and investigators
- Lead sponsor
- Pusan National University Yangsan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hee Yun Seol, Pusan National University Yangsan Hospital
- Investigators
- Hee Yun Seol, MD, PhD, Principal investigator, Pusan National University Yangsan Hospital, Yangsan, South Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06887335
- Sponsor's protocol ID
- 11-2025-013
- Status last verified
- Sep 2026
- First submitted
- 14 Mar 2025
- Last updated
- 18 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06887335
- Acronym / sponsor ID
- 11-2025-013
- Conditions
- Lung Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 191 participants (actual)
- Lead sponsor
- Pusan National University Yangsan HospitalUniversity, hospital or other
- Study start
- 8 Apr 2025 (actual)
- Primary completion
- 31 Mar 2026 (actual)
- Study completion
- 31 Mar 2026 (actual)
- First posted
- 20 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Week
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients requiring a bronchoscopy-assisted procedure for diagnostic or therapeutic purposes | – | Procedure: Deep Sedation Under Proceduralist Direction with Pre-emptive Endotracheal Intubation |
Who may qualify
- Ages
- 19 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with pulmonary lesions
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Deep Sedation Under Proceduralist Direction with Pre-emptive Endotracheal IntubationIf 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 | Procedure or surgery | Patients requiring a bronchoscopy-assisted procedure for diagnostic or therapeutic purposes |
Primary outcome
The incidence of hypoxia during deep sedation under proceduralist guidance with endotracheal intubation
Time frame: On the day of the bronchoscopy procedure, from the initiation of sedation therapy to the completion of the bronchoscopy procedure.
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.
3 secondary outcomes
The incidence of severe hypoxia during deep sedation under proceduralist guidance with endotracheal intubation
Time frame: On the day of the bronchoscopy procedure, from the initiation of sedation therapy to the completion of the bronchoscopy procedure.
The incidence of complications
Time frame: From the day of the bronchoscopy procedure to the outpatient visit one week after the procedure.
The rate of patient satisfaction
Time frame: From the completion of the bronchoscopy procedure to the point when the patient has fully recovered from sedation.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hee Yun Seol, MD, PhD principal investigator
Pusan National University Yangsan Hospital, Yangsan, South Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Diseases, run by Pusan National University Yangsan Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of hypoxia during deep sedation under proceduralist guidance with endotracheal intubation (time frame: On the day of the bronchoscopy procedure, from the initiation of sedation therapy to the completion of the bronchoscopy procedure.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.