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 volunteersQualifiers
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
Cohort
Prospective
Treatments tested in this trial
Deep Sedation Under Proceduralist Direction with Pre-emptive Endotracheal Intubation
Procedure/SurgeryIf 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
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
The incidence of complications
early termination or delay of the procedure, complications from endotracheal intubation, complications from bronchoscopy
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).
Sponsors and contacts
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