Practice of Oxygenation and Respiratory Support During Fiberoptic Bronchoscopy

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Magna Graecia

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Need for any procedure with flexible FOB

Either outpatients in dedicated ambulatories, and admitted to any hospital ward or Intensive Care Unit (ICU)

Disqualifiers

None

Trial population

We will include all adult patients requiring a flexible bronchoscopy for diagnostic or procedural reasons from all possible settings (from outpatients in dedicated ambulatories to patients admitted in any hospital ward or Intensive Care Unit)

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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).

Treatment groups

10,000 Participants
are divided into 5 treatment groups
Group A: Standard Oxygen Therapy (SOT)1 intervention
Group B: High Flow oxygen through Nasal Cannula (HFNC)1 intervention
Group C: Continuous Positive Airway Pressure (CPAP)1 intervention
Group D: Non-Invasive Ventilation (NIV)1 intervention
Group E: Invasive Mechanical Ventilation (iMV)1 intervention

Trial outcomes

Primary outcomes

1

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.

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

Secondary outcomes

1

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.

Time frame
Through the endoscopy completion, an average of 30 minutes
2

Lowest peripheral oxygen saturation

The lowest peripheral oxygen saturation recorded during the procedure

Time frame
Through the endoscopy completion, an average of 30 minutes
3

Lowest heart rate

The lowest heart rate recorded during the procedure

Time frame
Through the endoscopy completion, an average of 30 minutes
4

Highest heart rate

The highest heart rate recorded during the procedure

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

Other outcomes

Sponsors and contacts

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