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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05681962
Other study ID # OxyFOB study
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 15, 2023
Est. completion date April 30, 2024

Study information

Verified date August 2023
Source University Magna Graecia
Contact Federico Longhini, MD
Phone +393475395967
Email longhini.federico@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The current practice of oxygenation and/or ventilation supports in patients undergoing Fiberoptic Bronchoscopy is very heterogeneous among studies published in the literature; in addition, clear outcomes advantages of one strategy over another currently lack. The goal of this observational study is to describe the current practice of oxygenation and/or ventilation supports in patients undergoing Fiberoptic Bronchoscopy (FOB), stratified by baseline respiratory condition, co-morbidities, type of procedure and hospital settings. Investigators will enroll all adult patients undergoing any fiberoptic bronchoscopy in any clinical settings (from outpatients to critically ill patients). No specific exclusion criteria are indicated for enrollment in this study. Investigators will record the following data: - Patient's baseline data. - Type of FOB procedure: toilet bronchoscopy (for secretions, blood, mucus plugs removal), broncho-aspirate (BAS), bronchoalveolar lavage (BAL), brushing for cytology, biopsy, endobronchial ultrasound (EBUS). The type and size of bronchoscope (with or without an internal/external camera) and the time of the procedure will be also recorded. - Type of supportive strategy: no support, Standard Oxygen Therapy, High Flow Nasal Cannula, Continuous Positive Airway Pressure and or non invasive ventilation trough mask or helmet, invasive mechanical ventilation. - Sedation - Intra-procedural vital parameters - Occurrence of adverse events: desaturation (i.e. SpO2< 90% for at least 10 seconds), severe desaturation (i.e. SpO2< 80%), need for procedure interruption, hypotensive (systolic blood pressure <90 mmHg) or hypertensive (systolic blood pressure >140 mmHg) events, new onset of cardiac arrhythmias (specify the rhythm) or myocardial ischemia or electrocardiographic ST-alterations, neurological events (i.e. severe sensorium depression, psychomotor agitation). - Post-procedural vital parameters (15 minutes after the procedure). - Clinical outcomes: need for support escalation, need for admission to ward (for outpatient) or ICU (for outpatients and ward-admitted patient).


Recruitment information / eligibility

Status Recruiting
Enrollment 10000
Est. completion date April 30, 2024
Est. primary completion date March 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Need for any procedure with flexible FOB - Either outpatients in dedicated ambulatories, and admitted to any hospital ward or Intensive Care Unit (ICU) Exclusion Criteria: - None

Study Design


Intervention

Diagnostic Test:
Bronchoscopy
Patients will undergo to the bronchial endoscopy procedure required for their clinical condition: toilet bronchoscopy (for secretions, blood, mucus plugs removal), broncho-aspirate (BAS), bronchoalveolar lavage (BAL), brushing for cytology, biopsy, endobronchial ultrasound (EBUS).

Locations

Country Name City State
Italy AOU Mater Domini Catanzaro

Sponsors (1)

Lead Sponsor Collaborator
University Magna Graecia

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Type of oxygenation strategy adopted The type of oxygenation strategy (standard oxygen therapy, high flow nasal cannula, continuous positive airway pressure, non invasive ventilation or invasive mechanical ventilation) adopted during the bronchoscopy will be recorded. Through the endoscopy completion, an average of 30 minutes
Secondary Type of sedation strategy adopted The type of sedation strategy (topical anesthesia, midazolam, propofol, remifentanil, fentanyl, dexmedetomidine, neuromuscular blocking agents) adopted during the bronchoscopy will be recorded. Through the endoscopy completion, an average of 30 minutes
Secondary Lowest peripheral oxygen saturation The lowest peripheral oxygen saturation recorded during the procedure Through the endoscopy completion, an average of 30 minutes
Secondary Lowest heart rate The lowest heart rate recorded during the procedure Through the endoscopy completion, an average of 30 minutes
Secondary Highest heart rate The highest heart rate recorded during the procedure Through the endoscopy completion, an average of 30 minutes
Secondary Lowest systolic blood pressure The lowest systolic blood pressure recorded during the procedure Through the endoscopy completion, an average of 30 minutes
Secondary Highest systolic blood pressure The highest systolic blood pressure recorded during the procedure Through the endoscopy completion, an average of 30 minutes
Secondary Duration of the procedure The time duration of the procedure in minutes, from the beginning to the end of the endoscopy procedure From the beginning to the end of the endoscopy procedure
Secondary Desaturation events Occurrence of peripheral oxygen saturation < 90% for at least 10 seconds Through the endoscopy completion, an average of 30 minutes
Secondary Severe desaturation events Occurrence of peripheral oxygen saturation < 80% Through the endoscopy completion, an average of 30 minutes
Secondary Hypotensive events Occurrence of systolic blood pressure <90 mmHg Through the endoscopy completion, an average of 30 minutes
Secondary Hypertensive events Occurrence of systolic blood pressure >140 mmHg Through the endoscopy completion, an average of 30 minutes
Secondary Need for support escalation Need to escalate the oxygenation/ventilation support from from standard oxygen therapy (lowest support) to High Flow Nasal Cannula, Continuous Positive Airway Pressure, Non Invasive Ventilation or invasive Mechanical Ventilation (highest grade of support) Through the endoscopy completion, an average of 30 minutes
Secondary Admission to ward or intensive care unit Need for admission to ward or intensive care unit after the endoscopy completion At the end of the endoscopy completion, after an average of 30 minutes from study start
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