Practice of Oxygenation and Respiratory Support During Fiberoptic Bronchoscopy

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

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).

Study Overview

• Status: Recruiting
• Conditions: Pneumonia; Lung Cancer; Interstitial Lung Disease; Acute Respiratory Failure; Fibrosis Lung
• Intervention / Treatment: Diagnostic test: Bronchoscopy

• Study Type: Observational
• Enrollment (Estimated): 10000

Contacts and Locations

• Study Contact: Name: Federico Longhini, MD; Phone Number: +393475395967; Email: longhini.federico@gmail.com

Study Locations

• Italy
  • Catanzaro, Italy
    • Recruiting
    • AOU Mater Domini
    • Contact: Federico Longhini, MD; Phone Number: +3934753959697; Email: longhini.federico@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study 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)

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Standard Oxygen Therapy (SOT); Patients receiving low oxygen flow administration through nasal prongs, oxygen mask with or without reservoir, and Venturi mask.	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).
High Flow oxygen through Nasal Cannula (HFNC); Administration of high flows (up to 60 L/min) of air/oxygen admixtures, heated (at temperatures ranging from 31 to 37°C) and fully humidified (up to 44 mg H2O/L), providing an inspired oxygen fraction ranging from 21 to 100%	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).
Continuous Positive Airway Pressure (CPAP); application of positive end-expiratory pressure (PEEP) throughout the whole respiratory cycle by means of interfaces such as mask or helmet	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).
Non-Invasive Ventilation (NIV); application of a PEEP by means of a mask or helmet, with an inspiratory pressure support triggered by the patient and delivered by a ventilator and through interfaces such as mask or helmet	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).
Invasive Mechanical Ventilation (iMV); application of a ventilatory assistance in controlled or partial assisted modalities through an endotracheal or tracheostomy tube	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Lowest peripheral oxygen saturation	The lowest peripheral oxygen saturation recorded during the procedure	Through the endoscopy completion, an average of 30 minutes
Lowest heart rate	The lowest heart rate recorded during the procedure	Through the endoscopy completion, an average of 30 minutes
Highest heart rate	The highest heart rate recorded during the procedure	Through the endoscopy completion, an average of 30 minutes
Lowest systolic blood pressure	The lowest systolic blood pressure recorded during the procedure	Through the endoscopy completion, an average of 30 minutes
Highest systolic blood pressure	The highest systolic blood pressure recorded during the procedure	Through the endoscopy completion, an average of 30 minutes
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
Desaturation events	Occurrence of peripheral oxygen saturation < 90% for at least 10 seconds	Through the endoscopy completion, an average of 30 minutes
Severe desaturation events	Occurrence of peripheral oxygen saturation < 80%	Through the endoscopy completion, an average of 30 minutes
Hypotensive events	Occurrence of systolic blood pressure <90 mmHg	Through the endoscopy completion, an average of 30 minutes
Hypertensive events	Occurrence of systolic blood pressure >140 mmHg	Through the endoscopy completion, an average of 30 minutes
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
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

Collaborators and Investigators

• Sponsor: University Magna Graecia
• Investigators: Principal Investigator: Federico Longhini, MD, Magna Graecia University

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2023
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): January 31, 2026

Study Registration Dates

• First Submitted: January 3, 2023
• First Submitted That Met QC Criteria: January 3, 2023
• First Posted (Actual): January 12, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 24, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Bronchoscopy
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Fibrosis; Lung Diseases; Respiratory Insufficiency; Pulmonary Fibrosis; Lung Diseases, Interstitial
• Other Study ID Numbers: OxyFOB study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anonymous data will be shared after study publication on a peer-reviewed journal in english language, on a reasonable request to the principal investigator
• IPD Sharing Time Frame: After study publication on a peer-reviewed journal in english language
• IPD Sharing Access Criteria: On reasonable request to the Principal Investigator
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No