Acute Respiratory FailureFLOWEANNCT05577221
High Flow During Weaning From Mechanical Ventilation
A study testing High Flow Nasal Air in people with Acute Respiratory Failure, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Detection and relief of dyspnea in mechanically ventilated patients is a priority. Optimization of mechanical ventilation settings is unfortunately often insufficient to relieve dyspnea in patients entering the weaning process. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Acute Respiratory Failure
- What is being tested?
- High Flow Nasal Air
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 17 Feb 2023to 7 Sep 2023
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years old
- orotracheal intubation
- Decision to initiate a spontaneous breathing trial by the clinical team
- Visual analogic scale of dyspnea > 3/10
- Informed consent to participate
- Patient covered by the national health
Who cannot join
- No esophageal probe in place
- Extubation planned without a spontaneous breathing trial
- Glasgow coma scale< 12
- Patient's refusal
- No coverage by the national health insurance
- Patient under legal protection of justice
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of High Flow Nasal Air on Dyspnea During Weaning From Mechanical Ventilation
Detection and relief of dyspnea in mechanically ventilated patients is a priority. Optimization of mechanical ventilation settings is unfortunately often insufficient to relieve dyspnea in patients entering the weaning process. Pharmacological treatments are effective but their use is likely to delay separation with the ventilator. Promoting the development of non-pharmacological interventions is therefore an interesting avenue. The hypothesis is that the application of high-flow humidified nasal air in orotracheally intubated patients can decrease the work of breathing and relieve dyspnea at the time of weaning from mechanical ventilation. Patients will be exposed to stepwise increase in high flow nasal air (0 L/min, 30 L/min, 50 L/min and 70 L/min) before to undergo a 60 minutes spontaneous breathing trial. During the protocol, dyspnea, inspiratory effort, respiratory drive, respiratory muscles electromyogram (EMG) and patient's comfort will be assessed.
Read the detailed description
Patients equipped with an esophageal probe and deemed ready to undergo a spontaneous breathing trial will be included.
During, the inclusion visit, main characteristics of the patients and ICU stay will be collected in the patient's chart: age, sex, comorbidities, date of admission to intensive care, date of intubation, severity score (SOFA), reason for admission to intensive care , weight, height, ventilation settings, P0.1, respiratory rate, SpO2, dyspnea and comfort score.
Secondarily, the quality of the esophageal pressure signal will be checked. Esophageal pressure will be collected using a nasogastric tube (NutriventTM, SIDAM, Italy). Esophageal pressure will be measured continuously by the Labchart system installed on the department's dedicated computer.
Third, the EMG collection device will be implemented. EMG signals will be collected by surface electrodes on the scalene and intercostal muscles and on the sides of the nose. The electrodes are connected to collection modules operating with the LabChart system.
Finally, the high-flow humidified air device will be installed (AIRVO 2; Fisher and Paykel Healthcare, Auckland, New Zealand) and nasal cannulas adapted to the patient's anatomy will be positioned. The FiO2 will be fixed at 21% for the duration of the study. The flow will be set at 0 L/min at the inclusion visit. The humidified air temperature will be set to 37°C.
The protocol will consist of installing the high-flow humidified nasal oxygen therapy device and varying the nasal flow (4 different conditions: 0 L/min, 30 L/min, 50 L/min and 70 L/min) then performing the spontaneous breathing trial (duration 60 minutes). During each of the steps of the protocol, a collection of the intensity of the dyspnea, a measurement of the esophageal pressure, a measurement of the respiratory drive, an EMG measurement of the respiratory muscles and a comfort assessment will be carried out.
- Conditions
- Acute Respiratory Failure
- Being tested
- High Flow Nasal Air
- Keywords
- Dyspnea, Weaning, Mechanical ventilation, High flow nasal air
- Medical subject headings
- Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Flow Nasal AirDevice
Also called High Flow Nasal Cannula
Administration of air at high flow by using a high flow nasal oxygenation (FiO2 21%) device
| Study group | Role | What they receive |
|---|---|---|
| Collection of physiological parameters | Experimental | Installation of the high-flow humidified nasal oxygen therapy device and variation of the inspiratory flow rate (0 L/min, 30 L/min, 50 L/min and 70 L/min) then the weaning test will be performed. During each step of the protocol (= each variation of the inspiratory flow), the intensity of dyspnea will be collected, the esophageal pressure will be measured, the respiratory drive (P0.1) will be measured, the EMG of the respiratory muscles will be measured and the comfort will be measured. Each step lasts about 15 minutes with 5 minutes of wash-out before the next step. Once the 4 steps will be conducted, the weaning test will be performed (without wash-out), for a duration of one hour, 30 minutes with high flow humidified nasal oxygen (50 L/min) and 30 minutes without (both steps being randomized. The whole protocol will last 2h15. Receives: Device: High Flow Nasal Air |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of high-flow humidified nasal oxygen therapy on dyspnea in orotracheally intubated patients at the time of weaning from mechanical ventilation.
Dyspnea Numerical Rating Scale from 0 to 10
Measured: at inclusion, compare to 15, 35, 55, 75, 105 and 135 min
The effect of high-flow humidified nasal oxygen therapy on dyspnea in orotracheally intubated patients at the time of weaning from mechanical ventilation.
Mechanical Ventilation Respiratory Distress Observational Scale
Measured: at inclusion, compare to 15, 35, 55, 75, 105 and 135 min
Secondary outcomes (4)
inspiratory effort
Amplitude of the esophagus pressure
Measured: at inclusion, compare to 15, 35, 55, 75, 105 and 135 min
respiratory drive
inspiratory occlusion pressure (P0.1)
Measured: at inclusion, compare to 15, 35, 55, 75, 105 and 135 min
respiratory muscles activity
electromyogram of the respiratory muscles
Measured: at 15 min to inclusion, compare to, 35, 55, 75, 105 and 135 min
patient comfort
Visual analogic scale. Scale of 1 to 10 with 10 corresponding to minimal comfort
Measured: at inclusion, compare to 15, 35, 55, 75, 105 and 135 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2022
- Study start17 Feb 2023
- Primary completion7 Sep 2023
- Study completion7 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory FailureStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05577221
- Sponsor's protocol ID
- APHP221010
- Acronym
- FLOWEAN
- Status last verified
- Aug 2024
- First submitted
- 26 Sep 2022
- Last updated
- 13 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of High Flow Nasal Air on Dyspnea During Weaning From Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT05577221
- Acronym / sponsor ID
- FLOWEAN / APHP221010
- Conditions
- Acute Respiratory Failure
- Keywords
- Dyspnea, Weaning, Mechanical ventilation, High flow nasal air
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 17 Feb 2023 (actual)
- Primary completion
- 7 Sep 2023 (actual)
- Study completion
- 7 Sep 2023 (actual)
- First posted
- 13 Oct 2022 (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.
Detection and relief of dyspnea in mechanically ventilated patients is a priority. Optimization of mechanical ventilation settings is unfortunately often insufficient to relieve dyspnea in patients entering the weaning process. Pharmacological treatments are effective but their use is likely to delay separation with the ventilator. Promoting the development of non-pharmacological interventions is therefore an interesting avenue. The hypothesis is that the application of high-flow humidified nasal air in orotracheally intubated patients can decrease the work of breathing and relieve dyspnea at the time of weaning from mechanical ventilation. Patients will be exposed to stepwise increase in high flow nasal air (0 L/min, 30 L/min, 50 L/min and 70 L/min) before to undergo a 60 minutes spontaneous breathing trial. During the protocol, dyspnea, inspiratory effort, respiratory drive, respiratory muscles electromyogram (EMG) and patient's comfort will be assessed.
Detailed description
Patients equipped with an esophageal probe and deemed ready to undergo a spontaneous breathing trial will be included.
During, the inclusion visit, main characteristics of the patients and ICU stay will be collected in the patient's chart: age, sex, comorbidities, date of admission to intensive care, date of intubation, severity score (SOFA), reason for admission to intensive care , weight, height, ventilation settings, P0.1, respiratory rate, SpO2, dyspnea and comfort score.
Secondarily, the quality of the esophageal pressure signal will be checked. Esophageal pressure will be collected using a nasogastric tube (NutriventTM, SIDAM, Italy). Esophageal pressure will be measured continuously by the Labchart system installed on the department's dedicated computer.
Third, the EMG collection device will be implemented. EMG signals will be collected by surface electrodes on the scalene and intercostal muscles and on the sides of the nose. The electrodes are connected to collection modules operating with the LabChart system.
Finally, the high-flow humidified air device will be installed (AIRVO 2; Fisher and Paykel Healthcare, Auckland, New Zealand) and nasal cannulas adapted to the patient's anatomy will be positioned. The FiO2 will be fixed at 21% for the duration of the study. The flow will be set at 0 L/min at the inclusion visit. The humidified air temperature will be set to 37°C.
The protocol will consist of installing the high-flow humidified nasal oxygen therapy device and varying the nasal flow (4 different conditions: 0 L/min, 30 L/min, 50 L/min and 70 L/min) then performing the spontaneous breathing trial (duration 60 minutes). During each of the steps of the protocol, a collection of the intensity of the dyspnea, a measurement of the esophageal pressure, a measurement of the respiratory drive, an EMG measurement of the respiratory muscles and a comfort assessment will be carried out.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Collection of physiological parameters | Experimental | Device: High Flow Nasal AirInstallation of the high-flow humidified nasal oxygen therapy device and variation of the inspiratory flow rate (0 L/min, 30 L/min, 50 L/min and 70 L/min) then the weaning test will be performed. During each step of the protocol (= each variation of the inspiratory flow), the intensity of dyspnea will be collected, the esophageal pressure will be measured, the respiratory drive (P0.1) will be measured, the EMG of the respiratory muscles will be measured and the comfort will be measured. Each step lasts about 15 minutes with 5 minutes of wash-out before the next step. Once the 4 steps will be conducted, the weaning test will be performed (without wash-out), for a duration of one hour, 30 minutes with high flow humidified nasal oxygen (50 L/min) and 30 minutes without (both steps being randomized. The whole protocol will last 2h15. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age > 18 years old
- orotracheal intubation
- Decision to initiate a spontaneous breathing trial by the clinical team
- Visual analogic scale of dyspnea > 3/10
- Informed consent to participate
Key exclusion criteria (6 listed)
- No esophageal probe in place
- Extubation planned without a spontaneous breathing trial
- Glasgow coma scale< 12
- Patient's refusal
- No coverage by the national health insurance
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 Nasal AirAlso: High Flow Nasal CannulaAdministration of air at high flow by using a high flow nasal oxygenation (FiO2 21%) device | Device | Collection of physiological parameters |
Primary outcome
The effect of high-flow humidified nasal oxygen therapy on dyspnea in orotracheally intubated patients at the time of weaning from mechanical ventilation.
Time frame: at inclusion, compare to 15, 35, 55, 75, 105 and 135 min
Dyspnea Numerical Rating Scale from 0 to 10
The effect of high-flow humidified nasal oxygen therapy on dyspnea in orotracheally intubated patients at the time of weaning from mechanical ventilation.
Time frame: at inclusion, compare to 15, 35, 55, 75, 105 and 135 min
Mechanical Ventilation Respiratory Distress Observational Scale
4 secondary outcomes
inspiratory effort
Time frame: at inclusion, compare to 15, 35, 55, 75, 105 and 135 min
respiratory drive
Time frame: at inclusion, compare to 15, 35, 55, 75, 105 and 135 min
respiratory muscles activity
Time frame: at 15 min to inclusion, compare to, 35, 55, 75, 105 and 135 min
patient comfort
Time frame: at inclusion, compare to 15, 35, 55, 75, 105 and 135 min
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 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 Nasal Air in people with Acute Respiratory Failure, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 6 inclusion and 6 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: finished, as of the sponsor's last update on 13 Aug 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The effect of high-flow humidified nasal oxygen therapy on dyspnea in orotracheally intubated patients at the time of weaning from mechanical ventilation. (time frame: at inclusion, compare to 15, 35, 55, 75, 105 and 135 min). The study lists 2 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 Aug 2024.