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NCT Number: NCT05681962

Practice of Oxygenation and Respiratory Support During Fiberoptic Bronchoscopy

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).

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bronchoscopy

Diagnostic Test

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).

Primary outcomes

  1. Type of oxygenation strategy adopted

    Time frame: Through the endoscopy completion, an average of 30 minutes

    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.

Secondary outcomes

  1. Type of sedation strategy adopted

    Time frame: Through the endoscopy completion, an average of 30 minutes

    The type of sedation strategy (topical anesthesia, midazolam, propofol, remifentanil, fentanyl, dexmedetomidine, neuromuscular blocking agents) adopted during the bronchoscopy will be recorded.

  2. Lowest peripheral oxygen saturation

    Time frame: Through the endoscopy completion, an average of 30 minutes

    The lowest peripheral oxygen saturation recorded during the procedure

  3. Lowest heart rate

    Time frame: Through the endoscopy completion, an average of 30 minutes

    The lowest heart rate recorded during the procedure

  4. Highest heart rate

    Time frame: Through the endoscopy completion, an average of 30 minutes

    The highest heart rate recorded during the procedure

  5. Lowest systolic blood pressure

    Time frame: Through the endoscopy completion, an average of 30 minutes

    The lowest systolic blood pressure recorded during the procedure

  6. Highest systolic blood pressure

    Time frame: Through the endoscopy completion, an average of 30 minutes

    The highest systolic blood pressure recorded during the procedure

  7. Duration of the procedure

    Time frame: From the beginning to the end of the endoscopy procedure

    The time duration of the procedure in minutes, from the beginning to the end of the endoscopy procedure

  8. Desaturation events

    Time frame: Through the endoscopy completion, an average of 30 minutes

    Occurrence of peripheral oxygen saturation < 90% for at least 10 seconds

  9. Severe desaturation events

    Time frame: Through the endoscopy completion, an average of 30 minutes

    Occurrence of peripheral oxygen saturation < 80%

  10. Hypotensive events

    Time frame: Through the endoscopy completion, an average of 30 minutes

    Occurrence of systolic blood pressure <90 mmHg

  11. Hypertensive events

    Time frame: Through the endoscopy completion, an average of 30 minutes

    Occurrence of systolic blood pressure >140 mmHg

  12. Need for support escalation

    Time frame: Through the endoscopy completion, an average of 30 minutes

    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)

  13. Admission to ward or intensive care unit

    Time frame: At the end of the endoscopy completion, after an average of 30 minutes from study start

    Need for admission to ward or intensive care unit after the endoscopy completion

Study contacts

Contact information is provided by the study sponsor or research team.

Federico Longhini, MD

CONTACT

[email protected]

+393475395967

Sponsors and collaborators

Lead sponsor

University Magna Graecia

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Jan 12, 2023
Registry last updated
Dec 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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