ClinicalTrials.gov
ClinicalTrials.gov Menu

Expiratory Flow Limitation Assessment (FLAIR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03462849
Recruitment Status : Recruiting
First Posted : March 13, 2018
Last Update Posted : March 13, 2018
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief 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). 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.

Condition or disease Intervention/treatment Phase
Acute Respiratory Distress Syndrome Other: increase in positive end expiratory pressure Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Expiratory Fow Assessment in ARDS Patients
Actual Study Start Date : February 5, 2018
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : February 2019


Arm Intervention/treatment
Patients with EFL at PEP 5
Patients with EFL at PEP 5 at the time of inclusion either in supine or semi-recumbent position
Other: increase in positive end expiratory pressure
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

Patients with no EFL at PEP 5
Patients with no EFL at PEP 5 at the time of inclusion in both supine and semi-recumbent positions
Other: increase in positive end expiratory pressure
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Trans-pulmonary pressure at end expiratory at PEP 5 [ Time Frame: at inclusion ]
    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

  2. 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 ]
    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

  3. Lung compliance at PEP 10 in EFL and NFL patients [ Time Frame: 15 minutes after PEP set to 10 cm H2O ]
    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

  4. lung ventilation distribution at PEP 10 in EFL and NFL patients [ Time Frame: 15 minutes after PEP set to 10 cm H2O ]
    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).

  5. arterial blood gas at PEP 10 in EFL and NFL patients [ Time Frame: 15 minutes after PEP set to 10 cm H2O ]
    PEP is increased to 10 cmH2O and 15 minutes later arterial blood is drawn for PaO2, PaCO2 and pH measurement.

  6. 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 ]
    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

  7. Lung compliance at PEP 15 in EFL and NFL patients [ Time Frame: 15 minutes after PEP set to 15 cm H2O ]
    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

  8. lung ventilation distribution at PEP 15 in EFL and NFL patients [ Time Frame: 15 minutes after PEP set to 15 cm H2O ]
    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).

  9. arterial blood gas at PEP 15 in EFL and NFL patients [ Time Frame: 15 minutes after PEP set to 15 cm H2O ]
    PEP is increased to 15 cmH2O and 15 minutes later arterial blood is drawn for PaO2, PaCO2 and pH measurement.

  10. 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 ]
    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

  11. 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 ]
    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

  12. 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 ]
    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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • active therapy limitation
  • under guardian
  • refusal to participate
  • not affiliated to insurance regimen
  • speaking barrier of the next of kin
  • investigator not available

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03462849


Contacts
Contact: Claude Guerin, Pr 426109418 ext +33 claude.guerin@chu-lyon.fr

Locations
France
Hôpital de la Croix Rousse Recruiting
Lyon, France, 69004
Contact: Claude Guerin, Pr    426109418 ext +33    claude.guerin@chu-lyon.fr   
Contact: Loredana Baboi    426109265 ext +33    loredana.baboi@chu-lyon.fr   
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
Principal Investigator: Claude Guerin, Pr Hospices Civils de Lyon

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03462849     History of Changes
Other Study ID Numbers: 69HCL17_0595
First Posted: March 13, 2018    Key Record Dates
Last Update Posted: March 13, 2018
Last Verified: March 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hospices Civils de Lyon:
ARDS
expiratory flow limitation
trans-pulmonary pressure
airway closure

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury