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Practice of Oxygenation and Respiratory Support During Fiberoptic Bronchoscopy

Practice of Oxygenation and Respiratory Support During Fiberoptic Bronchoscopy: the Oxy-FOB STUDY

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05681962
Enrollment
10000
Registered
2023-01-12
Start date
2023-02-15
Completion date
2026-01-31
Last updated
2024-12-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Respiratory Failure, Fibrosis Lung, Interstitial Lung Disease, Lung Cancer, Pneumonia

Keywords

Bronchoscopy

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).

Interventions

DIAGNOSTIC_TESTBronchoscopy

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).

Sponsors

University Magna Graecia
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Type of oxygenation strategy adoptedThrough the endoscopy completion, an average of 30 minutesThe 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.

Secondary

MeasureTime frameDescription
Lowest peripheral oxygen saturationThrough the endoscopy completion, an average of 30 minutesThe lowest peripheral oxygen saturation recorded during the procedure
Lowest heart rateThrough the endoscopy completion, an average of 30 minutesThe lowest heart rate recorded during the procedure
Highest heart rateThrough the endoscopy completion, an average of 30 minutesThe highest heart rate recorded during the procedure
Lowest systolic blood pressureThrough the endoscopy completion, an average of 30 minutesThe lowest systolic blood pressure recorded during the procedure
Highest systolic blood pressureThrough the endoscopy completion, an average of 30 minutesThe highest systolic blood pressure recorded during the procedure
Duration of the procedureFrom the beginning to the end of the endoscopy procedureThe time duration of the procedure in minutes, from the beginning to the end of the endoscopy procedure
Type of sedation strategy adoptedThrough the endoscopy completion, an average of 30 minutesThe type of sedation strategy (topical anesthesia, midazolam, propofol, remifentanil, fentanyl, dexmedetomidine, neuromuscular blocking agents) adopted during the bronchoscopy will be recorded.
Severe desaturation eventsThrough the endoscopy completion, an average of 30 minutesOccurrence of peripheral oxygen saturation \< 80%
Hypotensive eventsThrough the endoscopy completion, an average of 30 minutesOccurrence of systolic blood pressure \<90 mmHg
Hypertensive eventsThrough the endoscopy completion, an average of 30 minutesOccurrence of systolic blood pressure \>140 mmHg
Need for support escalationThrough the endoscopy completion, an average of 30 minutesNeed 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)
Admission to ward or intensive care unitAt the end of the endoscopy completion, after an average of 30 minutes from study startNeed for admission to ward or intensive care unit after the endoscopy completion
Desaturation eventsThrough the endoscopy completion, an average of 30 minutesOccurrence of peripheral oxygen saturation \< 90% for at least 10 seconds

Countries

Italy

Contacts

Primary ContactFederico Longhini, MD
longhini.federico@gmail.com+393475395967

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026