Practice of Oxygenation and Respiratory Support During Fiberoptic Bronchoscopy

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05681962
• Other study ID #: OxyFOB study
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Acute Respiratory Failure
• Fibrosis Lung
• Interstitial Lung Disease
• Lung Cancer
• Lung Diseases
• Lung Diseases, Interstitial
• Pneumonia
• Pulmonary Fibrosis
• Respiratory Insufficiency

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