NCT05681962 Practice of Oxygenation and Respiratory Support During Fiberoptic Bronchoscopy
| NCT ID | NCT05681962 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Magna Graecia |
| Condition | Acute Respiratory Failure |
| Study Type | OBSERVATIONAL |
| Enrollment | 10,000 participants |
| Start Date | 2023-02-15 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 10,000 participants in total. It began in 2023-02-15 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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).
Eligibility Criteria
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
Contact & Investigator
Federico Longhini, MD
PRINCIPAL INVESTIGATOR
Magna Graecia University
Frequently Asked Questions
Who can join the NCT05681962 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Acute Respiratory Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05681962 currently recruiting?
Yes, NCT05681962 is actively recruiting participants. Contact the research team at longhini.federico@gmail.com for enrollment information.
Where is the NCT05681962 trial being conducted?
This trial is being conducted at Catanzaro, Italy.
Who is sponsoring the NCT05681962 clinical trial?
NCT05681962 is sponsored by University Magna Graecia. The principal investigator is Federico Longhini, MD at Magna Graecia University. The trial plans to enroll 10,000 participants.