Acute Respiratory FailureNCT05681962
Practice of Oxygenation and Respiratory Support During Fiberoptic Bronchoscopy
An observational study of Acute Respiratory Failure and Pneumonia, run by University Magna Graecia at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Failure, Pneumonia, Lung Cancer
- What is being tested?
- Bronchoscopy
- How many people
- 10,000 participants
- Where
- 1 siteItaly
- Study dates
- 15 Feb 2023to 31 Jan 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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)
Who may be able to join
- Need for any procedure with flexible FOB
- Either outpatients in dedicated ambulatories, and admitted to any hospital ward or Intensive Care Unit (ICU)
Who cannot join
- None
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
AOU Mater Domini
Catanzaro
Federico Longhini, MD, +3934753959697, longhini.federico@gmail.com
About this study
Official title: 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.
Read more
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).
- Conditions
- Acute Respiratory Failure, Pneumonia, Lung Cancer, Fibrosis Lung, Interstitial Lung Disease
- Being tested
- Bronchoscopy
- Keywords
- Bronchoscopy
- Medical subject headings
- Pneumonia, Lung Neoplasms, Pulmonary Fibrosis, Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BronchoscopyDiagnostic 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).
| Study group | Role | What they receive |
|---|---|---|
| Standard Oxygen Therapy (SOT) | Patients receiving low oxygen flow administration through nasal prongs, oxygen mask with or without reservoir, and Venturi mask. Receives: Diagnostic Test: Bronchoscopy | |
| 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% Receives: Diagnostic Test: Bronchoscopy | |
| 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 Receives: Diagnostic Test: Bronchoscopy | |
| 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 Receives: Diagnostic Test: Bronchoscopy | |
| Invasive Mechanical Ventilation (iMV) | application of a ventilatory assistance in controlled or partial assisted modalities through an endotracheal or tracheostomy tube Receives: Diagnostic Test: Bronchoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through the endoscopy completion, an average of 30 minutes
Secondary outcomes (13)
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.
Measured: Through the endoscopy completion, an average of 30 minutes
Lowest peripheral oxygen saturation
The lowest peripheral oxygen saturation recorded during the procedure
Measured: Through the endoscopy completion, an average of 30 minutes
Lowest heart rate
The lowest heart rate recorded during the procedure
Measured: Through the endoscopy completion, an average of 30 minutes
Highest heart rate
The highest heart rate recorded during the procedure
Measured: Through the endoscopy completion, an average of 30 minutes
Lowest systolic blood pressure
The lowest systolic blood pressure recorded during the procedure
Measured: Through the endoscopy completion, an average of 30 minutes
Highest systolic blood pressure
The highest systolic blood pressure recorded during the procedure
Measured: 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
Measured: From the beginning to the end of the endoscopy procedure
Desaturation events
Occurrence of peripheral oxygen saturation < 90% for at least 10 seconds
Measured: Through the endoscopy completion, an average of 30 minutes
Severe desaturation events
Occurrence of peripheral oxygen saturation < 80%
Measured: Through the endoscopy completion, an average of 30 minutes
Hypotensive events
Occurrence of systolic blood pressure <90 mmHg
Measured: Through the endoscopy completion, an average of 30 minutes
Hypertensive events
Occurrence of systolic blood pressure >140 mmHg
Measured: 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)
Measured: 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
Measured: At the end of the endoscopy completion, after an average of 30 minutes from study start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2023
- Study start15 Feb 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Respiratory FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Magna Graecia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Federico Longhini, University Magna Graecia
- Investigators
- Federico Longhini, MD, Principal investigator, Magna Graecia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05681962
- Sponsor's protocol ID
- OxyFOB study
- Status last verified
- Dec 2024
- First submitted
- 3 Jan 2023
- Last updated
- 30 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymous data will be shared after study publication on a peer-reviewed journal in english language, on a reasonable request to the principal investigator
Publications
Longhini F, Crimi C, Noto A, Pelaia C, Karakurt Z, Skoczynski S, Boleo-Tome JP, Winck JC, Esquinas AM, Melhorn J, Corneci D, Pobeha P, Bosco V, Garofalo E, Bruni A, Cammarota G, Todorova V, Puci MV, Sotgiu G, Kostikas K, Maggiore SM, De Robertis E, Ergan B, Landoni G, Simonte R, Nava S, Navalesi P, Scala R; OxyFOB study group. Practice of oxygenation and respiratory support during fibreoptic bronchoscopy: the OxyFOB study protocol. BMJ Open. 2025 Sep 2;15(9):e104747. doi: 10.1136/bmjopen-2025-104747.
PubMed 40897500
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Practice of Oxygenation and Respiratory Support During Fiberoptic Bronchoscopy: the Oxy-FOB STUDY
- ClinicalTrials.gov ID
- NCT05681962
- Acronym / sponsor ID
- OxyFOB study
- Conditions
- Acute Respiratory Failure, Pneumonia, Lung Cancer, Fibrosis Lung, Interstitial Lung Disease
- Keywords
- Bronchoscopy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- University Magna GraeciaUniversity, hospital or other
- Study start
- 15 Feb 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Jan 2026 (estimated)
- First posted
- 12 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Standard Oxygen Therapy (SOT) | – | Diagnostic Test: BronchoscopyPatients receiving low oxygen flow administration through nasal prongs, oxygen mask with or without reservoir, and Venturi mask. |
| High Flow oxygen through Nasal Cannula (HFNC) | – | Diagnostic Test: BronchoscopyAdministration 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% |
| Continuous Positive Airway Pressure (CPAP) | – | Diagnostic Test: Bronchoscopyapplication of positive end-expiratory pressure (PEEP) throughout the whole respiratory cycle by means of interfaces such as mask or helmet |
| Non-Invasive Ventilation (NIV) | – | Diagnostic Test: Bronchoscopyapplication 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 |
| Invasive Mechanical Ventilation (iMV) | – | Diagnostic Test: Bronchoscopyapplication of a ventilatory assistance in controlled or partial assisted modalities through an endotracheal or tracheostomy tube |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (2 listed)
- Need for any procedure with flexible FOB
- Either outpatients in dedicated ambulatories, and admitted to any hospital ward or Intensive Care Unit (ICU)
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BronchoscopyPatients 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). | Diagnostic test | Continuous Positive Airway Pressure (CPAP), High Flow oxygen through Nasal Cannula (HFNC), Invasive Mechanical Ventilation (iMV), Non-Invasive Ventilation (NIV), Standard Oxygen Therapy (SOT) |
Primary outcome
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.
13 secondary outcomes
Type of sedation strategy adopted
Time frame: Through the endoscopy completion, an average of 30 minutes
Lowest peripheral oxygen saturation
Time frame: Through the endoscopy completion, an average of 30 minutes
Lowest heart rate
Time frame: Through the endoscopy completion, an average of 30 minutes
Highest heart rate
Time frame: Through the endoscopy completion, an average of 30 minutes
Lowest systolic blood pressure
Time frame: Through the endoscopy completion, an average of 30 minutes
Highest systolic blood pressure
Time frame: Through the endoscopy completion, an average of 30 minutes
Duration of the procedure
Time frame: From the beginning to the end of the endoscopy procedure
Desaturation events
Time frame: Through the endoscopy completion, an average of 30 minutes
Severe desaturation events
Time frame: Through the endoscopy completion, an average of 30 minutes
Hypotensive events
Time frame: Through the endoscopy completion, an average of 30 minutes
Hypertensive events
Time frame: Through the endoscopy completion, an average of 30 minutes
Need for support escalation
Time frame: Through the endoscopy completion, an average of 30 minutes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2024.
- Derived from this study: PubMed 40897500Longhini F, Crimi C, Noto A, Pelaia C, Karakurt Z, Skoczynski S, Boleo-Tome JP, Winck JC, Esquinas AM, Melhorn J, Corneci D, Pobeha P, Bosco V, Garofalo E, Bruni A, Cammarota G, Todorova V, Puci MV, Sotgiu G, Kostikas K, Maggiore SM, De Robertis E, Ergan B, Landoni G, Simonte R, Nava S, Navalesi P, Scala R; OxyFOB study group. Practice of oxygenation and respiratory support during fibreoptic bronchoscopy: the OxyFOB study protocol. BMJ Open. 2025 Sep 2;15(9):e104747. doi: 10.1136/bmjopen-2025-104747.
- Individual participant dataSharing planned: Yes. Anonymous data will be shared after study publication on a peer-reviewed journal in english language, on a reasonable request to the principal investigator
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Federico Longhini, MD principal investigator
Magna Graecia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Respiratory Failure and Pneumonia, run by University Magna Graecia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Federico Longhini, MD (+393475395967, longhini.federico@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Type of oxygenation strategy adopted (time frame: Through the endoscopy completion, an average of 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05681962, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2024.