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

ConditionLung Diseases
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age19-90
SponsorPusan National University Yangsan Hospital

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

Patients with pulmonary lesions

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Deep Sedation Under Proceduralist Direction with Pre-emptive Endotracheal Intubation

    Procedure/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

Treatment groups

203 Participants
are divided into 1 treatment group
Group A: Patients requiring a bronchoscopy-assisted procedure for diagnostic or therapeutic purposes1 intervention

Trial outcomes

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.

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

Secondary outcomes

1

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.

Time frame
On the day of the bronchoscopy procedure, from the initiation of sedation therapy to the completion of the bronchoscopy procedure.
2

The incidence of complications

early termination or delay of the procedure, complications from endotracheal intubation, complications from bronchoscopy

Time frame
From the day of the bronchoscopy procedure to the outpatient visit one week after the procedure.
3

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).

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

Other outcomes

Sponsors and contacts

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