Acute Respiratory Distress SyndromeFLAIRNCT03462849
Expiratory Flow Limitation Assessment
A study testing increase in positive end expiratory pressure in people with Acute Respiratory Distress Syndrome, run by Hospices Civils de Lyon at 2 sites in France.
Trial summary
This study intended to assess the expiratory flow limitation (EFL) during tidal breath in patients intubated in intensive care unit (ICU) for moderate or severe acute respiratory distress syndrome (ARDS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome
- What is being tested?
- increase in positive end expiratory pressure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 2 sitesFrance
- Study dates
- 5 Feb 2018to 2 May 2019
- 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
- 18 years or more in age
- moderate to severe ARDS according to the Berlin definition : Intubated (or tracheotomized) and mechanically ventilated in the ICU
- no pregnancy
- informed consent from the next of kin
Who cannot join
- Contra-indication to PEP > 5 cmH2O
- extracorporeal membrane oxygenation (ECMO)
- chest tube
- mean arterial pressure < 65 mmHg
- Contra-indication to oesophageal device
- underlying disease fatal in less than one year
Show all 12Show fewer
- active therapy limitation
- under guardian
- refusal to participate
- not affiliated to insurance regimen
- speaking barrier of the next of kin
- investigator not available
Trial locations and contacts
2 sites in 1 country.
France2 sites
CHU Grenoble Alpes
Grenoble
Hôpital de la Croix Rousse
Lyon, 69004
About this study
Official title: Expiratory Fow Assessment in ARDS Patients
This study intended to assess the expiratory flow limitation (EFL) during tidal breath in patients intubated in intensive care unit (ICU) for moderate or severe acute respiratory distress syndrome (ARDS). EFL is defined as the lack of increase in expiratory flow in response to an increase in alveolar-to-atmospheric pressure gradient. It reflects airway closure. Early studies have been done using the Negative expiratory pressure (NEP) technique, which is no longer available. We proposed in present study a new method, which consists of diverting manually the expiratory flow to the atmosphere by-passing the expiratory valve. We aimed at assessing EFL at positive expiratory pressure (PEP) 5 cmH2O in semi-recumbent then in supine position together with measurement of trans-pulmonary pressure and regional lung ventilation. Higher PEP levels will be tested, namely 10, 15 and a trans-pulmonary PEP of 3 cmH2O, in semi-recumbent position.
- Conditions
- Acute Respiratory Distress Syndrome
- Being tested
- increase in positive end expiratory pressure
- Keywords
- ARDS, expiratory flow limitation, trans-pulmonary pressure, airway closure
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
increase in positive end expiratory pressureOther
increase in positive end expiratory pressure from 5 to 10 then 15 cmH2O then at the value for trans pulmonary end expiratory pressure amounting to 3 cmH2O
| Study group | Role | What they receive |
|---|---|---|
| Patients with EFL at PEP 5 | Other | Patients with EFL at PEP 5 at the time of inclusion either in supine or semi-recumbent position Receives: Other: increase in positive end expiratory pressure |
| Patients with no EFL at PEP 5 | Other | Patients with no EFL at PEP 5 at the time of inclusion in both supine and semi-recumbent positions Receives: Other: increase in positive end expiratory pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
EFL at PEP 5 cmH2O
A Fleish 2 pneumotachograph and a port to measure airway pressure are attached at the Y piece of the ventilator circuit and connected to a Biopac 150. At the end of inspiration the air is expelled to the atmosphere upstream the expiratory valve. The flow volume loop at baseline and that during the manoeuver are plotted and patients classified as EFL or not EFL (NFL). Measurements are taken in semi-recumbent then after 5 minutes in supine position.
Measured: at inclusion
Secondary outcomes (16)
Trans-pulmonary pressure at end expiratory at PEP 5
After insertion of esophageal balloon together with pneumotachograph and port for airway pressure trans-pulmonary pressure (airway-esophageal pressure) is measured after a 3-sec end-expiratory pause in semi-recumbent and then after 5 minutes in supine position
Measured: at inclusion
Trans-pulmonary pressure at end expiratory at PEP 10 in EFL and NFL patients
PEP is increased to 10 cmH2O and 15 minutes later trans-pulmonary pressure is measured after a 3-sec end-expiratory pause in semi-recumbent position
Measured: 15 minutes after PEP set to 10 cm H2O
Lung compliance at PEP 10 in EFL and NFL patients
PEP is increased to 10 cmH2O and 15 minutes later lung compliance is measured after a 3-sec end-expiratory pause in semi-recumbent position
Measured: 15 minutes after PEP set to 10 cm H2O
lung ventilation distribution at PEP 10 in EFL and NFL patients
PEP is increased to 10 cmH2O and 15 minutes later lung ventilation is measured by using electrical impedance tomography (EIT) in semi-recumbent position (an EIT belt having been inserted together with the previous measurement devices).
Measured: 15 minutes after PEP set to 10 cm H2O
Transcutaneous oxygen saturation (SpO2) at PEP 10 in EFL and NFL patients
PEP is increased to 15cmH2O and 15 minutes later SpO2 is read from the vital functions monitoring device and SpO2/FIO2 computed
Measured: 15 minutes after PEP set to 10 cm H2O
Trans-pulmonary pressure at end expiratory at PEP 15 in EFL and NFL patients
PEP is increased to 15 cmH2O and 15 minutes later trans-pulmonary pressure is measured after a 3-sec end-expiratory pause in semi-recumbent position
Measured: 15 minutes after PEP set to 15 cm H2O
Lung compliance at PEP 15 in EFL and NFL patients
PEP is increased to 15 cmH2O and 15 minutes later lung compliance is measured after a 3-sec end-expiratory pause in semi-recumbent position
Measured: 15 minutes after PEP set to 15 cm H2O
lung ventilation distribution at PEP 15 in EFL and NFL patients
PEP is increased to 15 cmH2O and 15 minutes later lung ventilation is measured by using electrical impedance tomography (EIT) in semi-recumbent position (an EIT belt having been inserted together with the previous measurement devices).
Measured: 15 minutes after PEP set to 15 cm H2O
transcutaneous oxygen saturation (SpO2) at PEP 15 in EFL and NFL patients
PEP is increased to 15 cmH2O and 15 minutes later SpO2 is read from the vital functions monitoring device and SpO2/FIO2 computed.
Measured: 15 minutes after PEP set to 15 cm H2O
Trans-pulmonary pressure at end expiratory at PEP to reach Trans-pulmonary pressure at end expiratory =+3 cmH2O in EFL and NFL patients
PEP is set to reach Trans-pulmonary pressure at end expiratory =+3 cmH2O and 15 minutes later trans-pulmonary pressure is measured after a 3-sec end-expiratory pause in semi-recumbent position
Measured: 15 minutes after PEP set to reach Trans-pulmonary pressure at end expiratory =+3 cmH2O
Lung compliance at PEP to reach Trans-pulmonary pressure at end expiratory =+3 cmH2O in EFL and NFL patients
PEP is set to reach Trans-pulmonary pressure at end expiratory =+3 cmH2O and 15 minutes later lung compliance is measured after a 3-sec end-expiratory pause in semi-recumbent position
Measured: 15 minutes after PEP set to reach Trans-pulmonary pressure at end expiratory =+3 cmH2O
lung ventilation distribution at PEP set to reach Trans-pulmonary pressure at end expiratory =+3 cmH2O in EFL and NFL patients
PEP is set to reach Trans-pulmonary pressure at end expiratory =+3 cmH2O and 15 minutes later lung ventilation is measured by using electrical impedance tomography (EIT) in semi-recumbent position (an EIT belt having been inserted together with the previous measurement devices).
Measured: 15 minutes after PEP set to reach Trans-pulmonary pressure at end expiratory =+3 cmH2O
Transcutaneous oxygen saturation (SpO2) at PEEP set to reach Trans-pulmonary pressure at end expiratory =+3 cmH2O in EFL and NFL patients
PEEP is increased to 15 cmH2O and 15 minutes later SpO2 is read from the vital functions monitoring device and SpO2/FIO2 computed.
Measured: 15 minutes after PEEP set to reach Trans-pulmonary pressure at end expiratory =+3 cmH2O
lung recruitment at PEEP 10 in EFL and NFL patients
PEEP is increased to 10 cmH2O and 15 minutes later lung recruitment is measured between PEEP 10 and PEEP 5 (in each body position) from volume-pressure curves recorded at PEEP 10 and PEEP 5. The lung recruitment is the change in lung volume for a given pressure (higher PEEP and 20 cmH2O)
Measured: 15 minutes after PEEP set to 10 cm H2O
lung recruitment at PEEP 15 in EFL and NFL patients
PEEP is increased to 15 cmH2O and 15 minutes later lung recruitment is measured between PEEP 15 and PEEP 5 (in each body position) from volume-pressure curves recorded at PEEP 15 and PEEP 5. The lung recruitment is the change in lung volume for a given pressure (higher PEEP and 20 cmH2O)
Measured: 15 minutes after PEEP set to 15 cm H2O
lung recruitment at PEEP set to reach Trans-pulmonary pressure at end expiratory =+3 cmH2O in EFL and NFL patients in EFL and NFL patients
PEEP is increased to PEEP set to reach Trans-pulmonary pressure at end expiratory =+3 cmH2O and 15 minutes later lung recruitment is measured between PEEP set to reach Trans-pulmonary pressure at end expiratory =+3 cmH2O and PEEP 5 (in each body position) from volume-pressure curves recorded at PEEP set to reach Trans-pulmonary pressure at end expiratory =+3 cmH2O and PEEP 5. The lung recruitment is the change in lung volume for a given pressure (higher PEEP and 20 cmH2O)
Measured: 15 minutes after PEEP set to 15 cm H2O
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2018
- Study start5 Feb 2018
- Primary completion2 May 2019
- Study completion2 May 2019
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 Distress SyndromeStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claude Guerin, Pr, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03462849
- Sponsor's protocol ID
- 69HCL17_0595
- Other IDs
- 2017-A02557-46
- Acronym
- FLAIR
- Status last verified
- Nov 2025
- First submitted
- 6 Mar 2018
- Last updated
- 5 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Guerin C, Terzi N, Galerneau LM, Mezidi M, Yonis H, Baboi L, Kreitmann L, Turbil E, Cour M, Argaud L, Louis B. Lung and chest wall mechanics in patients with acute respiratory distress syndrome, expiratory flow limitation, and airway closure. J Appl Physiol (1985). 2020 Jun 1;128(6):1594-1603. doi: 10.1152/japplphysiol.00059.2020. Epub 2020 Apr 30.
PubMed 32352339
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expiratory Fow Assessment in ARDS Patients
- ClinicalTrials.gov ID
- NCT03462849
- Acronym / sponsor ID
- FLAIR / 69HCL17_0595
- Conditions
- Acute Respiratory Distress Syndrome
- Keywords
- ARDS, expiratory flow limitation, trans-pulmonary pressure, airway closure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 5 Feb 2018 (actual)
- Primary completion
- 2 May 2019 (actual)
- Study completion
- 2 May 2019 (actual)
- First posted
- 13 Mar 2018 (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.
This study intended to assess the expiratory flow limitation (EFL) during tidal breath in patients intubated in intensive care unit (ICU) for moderate or severe acute respiratory distress syndrome (ARDS). EFL is defined as the lack of increase in expiratory flow in response to an increase in alveolar-to-atmospheric pressure gradient. It reflects airway closure. Early studies have been done using the Negative expiratory pressure (NEP) technique, which is no longer available. We proposed in present study a new method, which consists of diverting manually the expiratory flow to the atmosphere by-passing the expiratory valve. We aimed at assessing EFL at positive expiratory pressure (PEP) 5 cmH2O in semi-recumbent then in supine position together with measurement of trans-pulmonary pressure and regional lung ventilation. Higher PEP levels will be tested, namely 10, 15 and a trans-pulmonary PEP of 3 cmH2O, in semi-recumbent position.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with EFL at PEP 5 | Other | Other: increase in positive end expiratory pressurePatients with EFL at PEP 5 at the time of inclusion either in supine or semi-recumbent position |
| Patients with no EFL at PEP 5 | Other | Other: increase in positive end expiratory pressurePatients with no EFL at PEP 5 at the time of inclusion in both supine and semi-recumbent positions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years or more in age
- moderate to severe ARDS according to the Berlin definition : Intubated (or tracheotomized) and mechanically ventilated in the ICU
- no pregnancy
- informed consent from the next of kin
Key exclusion criteria (12 listed)
- Contra-indication to PEP > 5 cmH2O
- extracorporeal membrane oxygenation (ECMO)
- chest tube
- mean arterial pressure < 65 mmHg
- Contra-indication to oesophageal device
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 |
|---|---|---|
| increase in positive end expiratory pressureincrease in positive end expiratory pressure from 5 to 10 then 15 cmH2O then at the value for trans pulmonary end expiratory pressure amounting to 3 cmH2O | Other | Patients with EFL at PEP 5, Patients with no EFL at PEP 5 |
Primary outcome
EFL at PEP 5 cmH2O
Time frame: at inclusion
A Fleish 2 pneumotachograph and a port to measure airway pressure are attached at the Y piece of the ventilator circuit and connected to a Biopac 150. At the end of inspiration the air is expelled to the atmosphere upstream the expiratory valve. The flow volume loop at baseline and that during the manoeuver are plotted and patients classified as EFL or not EFL (NFL). Measurements are taken in semi-recumbent then after 5 minutes in supine position.
16 secondary outcomes
Trans-pulmonary pressure at end expiratory at PEP 5
Time frame: at inclusion
Trans-pulmonary pressure at end expiratory at PEP 10 in EFL and NFL patients
Time frame: 15 minutes after PEP set to 10 cm H2O
Lung compliance at PEP 10 in EFL and NFL patients
Time frame: 15 minutes after PEP set to 10 cm H2O
lung ventilation distribution at PEP 10 in EFL and NFL patients
Time frame: 15 minutes after PEP set to 10 cm H2O
Transcutaneous oxygen saturation (SpO2) at PEP 10 in EFL and NFL patients
Time frame: 15 minutes after PEP set to 10 cm H2O
Trans-pulmonary pressure at end expiratory at PEP 15 in EFL and NFL patients
Time frame: 15 minutes after PEP set to 15 cm H2O
Lung compliance at PEP 15 in EFL and NFL patients
Time frame: 15 minutes after PEP set to 15 cm H2O
lung ventilation distribution at PEP 15 in EFL and NFL patients
Time frame: 15 minutes after PEP set to 15 cm H2O
transcutaneous oxygen saturation (SpO2) at PEP 15 in EFL and NFL patients
Time frame: 15 minutes after PEP set to 15 cm H2O
Trans-pulmonary pressure at end expiratory at PEP to reach Trans-pulmonary pressure at end expiratory =+3 cmH2O in EFL and NFL patients
Time frame: 15 minutes after PEP set to reach Trans-pulmonary pressure at end expiratory =+3 cmH2O
Lung compliance at PEP to reach Trans-pulmonary pressure at end expiratory =+3 cmH2O in EFL and NFL patients
Time frame: 15 minutes after PEP set to reach Trans-pulmonary pressure at end expiratory =+3 cmH2O
lung ventilation distribution at PEP set to reach Trans-pulmonary pressure at end expiratory =+3 cmH2O in EFL and NFL patients
Time frame: 15 minutes after PEP set to reach Trans-pulmonary pressure at end expiratory =+3 cmH2O
Transcutaneous oxygen saturation (SpO2) at PEEP set to reach Trans-pulmonary pressure at end expiratory =+3 cmH2O in EFL and NFL patients
Time frame: 15 minutes after PEEP set to reach Trans-pulmonary pressure at end expiratory =+3 cmH2O
lung recruitment at PEEP 10 in EFL and NFL patients
Time frame: 15 minutes after PEEP set to 10 cm H2O
lung recruitment at PEEP 15 in EFL and NFL patients
Time frame: 15 minutes after PEEP set to 15 cm H2O
lung recruitment at PEEP set to reach Trans-pulmonary pressure at end expiratory =+3 cmH2O in EFL and NFL patients in EFL and NFL patients
Time frame: 15 minutes after PEEP set to 15 cm H2O
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 5 Dec 2025.
- Results publication: PubMed 32352339Guerin C, Terzi N, Galerneau LM, Mezidi M, Yonis H, Baboi L, Kreitmann L, Turbil E, Cour M, Argaud L, Louis B. Lung and chest wall mechanics in patients with acute respiratory distress syndrome, expiratory flow limitation, and airway closure. J Appl Physiol (1985). 2020 Jun 1;128(6):1594-1603. doi: 10.1152/japplphysiol.00059.2020. Epub 2020 Apr 30.
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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.
Claude Guerin, Pr principal investigator
Hospices Civils de Lyon
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing increase in positive end expiratory pressure in people with Acute Respiratory Distress Syndrome, run by Hospices Civils de Lyon at 2 sites 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 4 inclusion and 12 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 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
EFL at PEP 5 cmH2O (time frame: at inclusion). 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 NCT03462849, 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 5 Dec 2025.