Respiratory FailureBroncHoFlowNCT04728412
High Flow Oxygen Therapy in Patients Undergoing Bronchoscopy Under Sedation
A study testing High Flow Oxygen Therapy (HFOT) in people with Respiratory Failure and Hypercapnic Acidosis, run by Cardarelli Hospital at 1 site in Italy.
Trial summary
A reduction of peripheral oxygen saturation (SpO2) commonly occurs during bronchoscopy and may be associated with both respiratory and cardiac adverse events. The type of breathing assistance that should be delivered to patients, in order to treat and/or to prevent acute respiratory failure, during or after… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Failure, Hypercapnic Acidosis
- What is being tested?
- High Flow Oxygen Therapy (HFOT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2024to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Who may be able to join
- pH ≥7.30 e PaCO2 >45 mmHg and/or
- PaO2/FiO2 <300 mmHg o SpO2 <90 percent on room air
- Patient at risk of respiratory failure (COPD III-IV GOLD stage; OSAS; restrictive lung and chest wall diseases; cardiac failure)
Who cannot join
- Need of laryngeal mask and/or
- Patients on NIV for >16 hrs/day and/or
- pH <7.30 and/or
- Tracheostomy and/or
- Recent (<3 months) facial trauma and/or
- Hemodynamic instability and/or
- High risk of aspiration and/or
- Lacerated trachea
Trial locations and contacts
1 site in 1 country.
About this study
Official title: High Flow Oxygen Therapy in Patients With or at Risk of Respiratory Failure Undergoing Felxible Bronchoscopy Under Sedation: a Pilot Study
A reduction of peripheral oxygen saturation (SpO2) commonly occurs during bronchoscopy and may be associated with both respiratory and cardiac adverse events. The type of breathing assistance that should be delivered to patients, in order to treat and/or to prevent acute respiratory failure, during or after bronchoscopy, is not universally standardized; studies comparing the impact of different respiratory supports on patient's outcome and on hospital resource use are very few. the risk of respiratory failure rises according to the type of procedure (i.e., increased risk with broncho-alveolar lavage and trans-bronchial lung biopsy) and to the use of sedative drugs. Conventional oxygen therapy with nasal cannula, continuous positive airway pressure and non-invasive ventilation are commonly applied during endoscopic procedures. High flow oxygen therapy (HFOT) is a relatively novel device, still under-used in the context of interventional pulmonology, providing an humidified air-oxygen blend up to 60 L/min. HFOT has been reported to be effective for the treatment of both hypoxemic and hypercapnic respiratory failure. The investigators hypothesize that HFOT could be feasible and safe in patients undergoing bronchoscopy under moderate sedation, affected by or at risk of hypoxemic and/or hypercapnic respiratory failure.
- Conditions
- Respiratory Failure, Hypercapnic Acidosis
- Being tested
- High Flow Oxygen Therapy (HFOT)
- Keywords
- bronchoscopy, sedation, high flow oxygen therapy
- Medical subject headings
- Respiratory Insufficiency, Acidosis, Respiratory
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Flow Oxygen Therapy (HFOT)Device
HFOT administration in patients undergoing bronchoscopy under moderate sedation, affected by or at risk of hypoxemic and/or hypercapnic respiratory failure.
| Study group | Role | What they receive |
|---|---|---|
| patients undergoing bronchoscopy under sedation with or at risk of respiratory failure | Experimental | Not described Receives: Device: High Flow Oxygen Therapy (HFOT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of desaturation, defined as SpO2< 90 percent percent for >1 min, <5.
Measured: one year
Percent of variation of pH, comparing ABG performed before bronchoscopy with that performed before partecipant's transferral to recovery room.
Measured: one year
Percent of variation of PaCO2 variation, comparing ABG performed before bronchoscopy with that performed before partecipant's transferral to recovery room.
Measured: one year
Rate of interruption of bronchoscopy because of number of desaturation, defined as SpO2< 90 percent for >1 min, >5.
Measured: one year
Number of partecipants requiring an escalation of respiratory support.
Measured: one year
Rate of new appearance of hemodynamic instability.
Measured: one year
Secondary outcomes (7)
value of Charlson Comobidity Index associated with HFOT failure.
Measured: one year
value of Body Mass Index associated with HFOT failure.
Measured: one year
value of Borg dyspnea scale associated with HFOT failure.
Measured: one year
Number of desaturations, defined as SpO2< 90 percent for >1 min.
Measured: one year
Lowest oxygen saturation under HFOT.
Measured: one year
Rate of change of HFOT parameters because of desaturation without respiratory acidosis.
Measured: one year
Rate of change of HFOT parameters because of desaturation with respiratory acidosis
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2021
- Study start1 Sep 2024 (estimated)
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cardarelli Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giuseppe Failla, Cardarelli Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04728412
- Sponsor's protocol ID
- 00000
- Acronym
- BroncHoFlow
- Status last verified
- Feb 2024
- First submitted
- 12 Dec 2020
- Last updated
- 13 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Flow Oxygen Therapy in Patients With or at Risk of Respiratory Failure Undergoing Felxible Bronchoscopy Under Sedation: a Pilot Study
- ClinicalTrials.gov ID
- NCT04728412
- Acronym / sponsor ID
- BroncHoFlow / 00000
- Conditions
- Respiratory Failure, Hypercapnic Acidosis
- Keywords
- bronchoscopy, sedation, high flow oxygen therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Cardarelli HospitalUniversity, hospital or other
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 28 Jan 2021 (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.
A reduction of peripheral oxygen saturation (SpO2) commonly occurs during bronchoscopy and may be associated with both respiratory and cardiac adverse events. The type of breathing assistance that should be delivered to patients, in order to treat and/or to prevent acute respiratory failure, during or after bronchoscopy, is not universally standardized; studies comparing the impact of different respiratory supports on patient's outcome and on hospital resource use are very few. the risk of respiratory failure rises according to the type of procedure (i.e., increased risk with broncho-alveolar lavage and trans-bronchial lung biopsy) and to the use of sedative drugs. Conventional oxygen therapy with nasal cannula, continuous positive airway pressure and non-invasive ventilation are commonly applied during endoscopic procedures. High flow oxygen therapy (HFOT) is a relatively novel device, still under-used in the context of interventional pulmonology, providing an humidified air-oxygen blend up to 60 L/min. HFOT has been reported to be effective for the treatment of both hypoxemic and hypercapnic respiratory failure. The investigators hypothesize that HFOT could be feasible and safe in patients undergoing bronchoscopy under moderate sedation, affected by or at risk of hypoxemic and/or hypercapnic respiratory failure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients undergoing bronchoscopy under sedation with or at risk of respiratory failure | Experimental | Device: High Flow Oxygen Therapy (HFOT) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- pH ≥7.30 e PaCO2 >45 mmHg and/or
- PaO2/FiO2 <300 mmHg o SpO2 <90 percent on room air
- Patient at risk of respiratory failure (COPD III-IV GOLD stage; OSAS; restrictive lung and chest wall diseases; cardiac failure)
Key exclusion criteria (8 listed)
- Need of laryngeal mask and/or
- Patients on NIV for >16 hrs/day and/or
- pH <7.30 and/or
- Tracheostomy and/or
- Recent (<3 months) facial trauma and/or
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 |
|---|---|---|
| High Flow Oxygen Therapy (HFOT)HFOT administration in patients undergoing bronchoscopy under moderate sedation, affected by or at risk of hypoxemic and/or hypercapnic respiratory failure. | Device | patients undergoing bronchoscopy under sedation with or at risk of respiratory failure |
Primary outcome
Number of desaturation, defined as SpO2< 90 percent percent for >1 min, <5.
Time frame: one year
Percent of variation of pH, comparing ABG performed before bronchoscopy with that performed before partecipant's transferral to recovery room.
Time frame: one year
Percent of variation of PaCO2 variation, comparing ABG performed before bronchoscopy with that performed before partecipant's transferral to recovery room.
Time frame: one year
Rate of interruption of bronchoscopy because of number of desaturation, defined as SpO2< 90 percent for >1 min, >5.
Time frame: one year
Number of partecipants requiring an escalation of respiratory support.
Time frame: one year
Rate of new appearance of hemodynamic instability.
Time frame: one year
7 secondary outcomes
value of Charlson Comobidity Index associated with HFOT failure.
Time frame: one year
value of Body Mass Index associated with HFOT failure.
Time frame: one year
value of Borg dyspnea scale associated with HFOT failure.
Time frame: one year
Number of desaturations, defined as SpO2< 90 percent for >1 min.
Time frame: one year
Lowest oxygen saturation under HFOT.
Time frame: one year
Rate of change of HFOT parameters because of desaturation without respiratory acidosis.
Time frame: one year
Rate of change of HFOT parameters because of desaturation with respiratory acidosis
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2024.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Flow Oxygen Therapy (HFOT) in people with Respiratory Failure and Hypercapnic Acidosis, run by Cardarelli Hospital 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 3 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 13 Feb 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of desaturation, defined as SpO2< 90 percent percent for >1 min, <5. (time frame: one year). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Feb 2024.