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Expiratory Flow Limitation Assessment (FLAIR)

Primary Purpose

Acute Respiratory Distress Syndrome

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
increase in positive end expiratory pressure
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Acute Respiratory Distress Syndrome focused on measuring ARDS, expiratory flow limitation, trans-pulmonary pressure, airway closure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU Grenoble Alpes
  • Hôpital de la Croix Rousse

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Patients with EFL at PEP 5

Patients with no EFL at PEP 5

Arm Description

Patients with EFL at PEP 5 at the time of inclusion either in supine or semi-recumbent position

Patients with no EFL at PEP 5 at the time of inclusion in both supine and semi-recumbent positions

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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
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
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).
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
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
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
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).
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.
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
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
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).
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.
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)
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)
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)

Full Information

First Posted
March 6, 2018
Last Updated
August 13, 2019
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT03462849
Brief Title
Expiratory Flow Limitation Assessment
Acronym
FLAIR
Official Title
Expiratory Fow Assessment in ARDS Patients
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
February 5, 2018 (Actual)
Primary Completion Date
May 2, 2019 (Actual)
Study Completion Date
May 2, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Distress Syndrome
Keywords
ARDS, expiratory flow limitation, trans-pulmonary pressure, airway closure

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients with EFL at PEP 5
Arm Type
Other
Arm Description
Patients with EFL at PEP 5 at the time of inclusion either in supine or semi-recumbent position
Arm Title
Patients with no EFL at PEP 5
Arm Type
Other
Arm Description
Patients with no EFL at PEP 5 at the time of inclusion in both supine and semi-recumbent positions
Intervention Type
Other
Intervention Name(s)
increase in positive end expiratory pressure
Intervention Description
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 Measure Information:
Title
EFL at PEP 5 cmH2O
Description
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.
Time Frame
at inclusion
Secondary Outcome Measure Information:
Title
Trans-pulmonary pressure at end expiratory at PEP 5
Description
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
Time Frame
at inclusion
Title
Trans-pulmonary pressure at end expiratory at PEP 10 in EFL and NFL patients
Description
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
Time Frame
15 minutes after PEP set to 10 cm H2O
Title
Lung compliance at PEP 10 in EFL and NFL patients
Description
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
Time Frame
15 minutes after PEP set to 10 cm H2O
Title
lung ventilation distribution at PEP 10 in EFL and NFL patients
Description
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).
Time Frame
15 minutes after PEP set to 10 cm H2O
Title
Transcutaneous oxygen saturation (SpO2) at PEP 10 in EFL and NFL patients
Description
PEP is increased to 15cmH2O and 15 minutes later SpO2 is read from the vital functions monitoring device and SpO2/FIO2 computed
Time Frame
15 minutes after PEP set to 10 cm H2O
Title
Trans-pulmonary pressure at end expiratory at PEP 15 in EFL and NFL patients
Description
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
Time Frame
15 minutes after PEP set to 15 cm H2O
Title
Lung compliance at PEP 15 in EFL and NFL patients
Description
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
Time Frame
15 minutes after PEP set to 15 cm H2O
Title
lung ventilation distribution at PEP 15 in EFL and NFL patients
Description
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).
Time Frame
15 minutes after PEP set to 15 cm H2O
Title
transcutaneous oxygen saturation (SpO2) at PEP 15 in EFL and NFL patients
Description
PEP is increased to 15 cmH2O and 15 minutes later SpO2 is read from the vital functions monitoring device and SpO2/FIO2 computed.
Time Frame
15 minutes after PEP set to 15 cm H2O
Title
Trans-pulmonary pressure at end expiratory at PEP to reach Trans-pulmonary pressure at end expiratory =+3 cmH2O in EFL and NFL patients
Description
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
Time Frame
15 minutes after PEP set to reach Trans-pulmonary pressure at end expiratory =+3 cmH2O
Title
Lung compliance at PEP to reach Trans-pulmonary pressure at end expiratory =+3 cmH2O in EFL and NFL patients
Description
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
Time Frame
15 minutes after PEP set to reach Trans-pulmonary pressure at end expiratory =+3 cmH2O
Title
lung ventilation distribution at PEP set to reach Trans-pulmonary pressure at end expiratory =+3 cmH2O in EFL and NFL patients
Description
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).
Time Frame
15 minutes after PEP set to reach Trans-pulmonary pressure at end expiratory =+3 cmH2O
Title
Transcutaneous oxygen saturation (SpO2) at PEEP set to reach Trans-pulmonary pressure at end expiratory =+3 cmH2O in EFL and NFL patients
Description
PEEP is increased to 15 cmH2O and 15 minutes later SpO2 is read from the vital functions monitoring device and SpO2/FIO2 computed.
Time Frame
15 minutes after PEEP set to reach Trans-pulmonary pressure at end expiratory =+3 cmH2O
Title
lung recruitment at PEEP 10 in EFL and NFL patients
Description
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)
Time Frame
15 minutes after PEEP set to 10 cm H2O
Title
lung recruitment at PEEP 15 in EFL and NFL patients
Description
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)
Time Frame
15 minutes after PEEP set to 15 cm H2O
Title
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
Description
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)
Time Frame
15 minutes after PEEP set to 15 cm H2O

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claude Guerin, Pr
Organizational Affiliation
Hospices Civils de Lyon
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Grenoble Alpes
City
Grenoble
Country
France
Facility Name
Hôpital de la Croix Rousse
City
Lyon
ZIP/Postal Code
69004
Country
France

12. IPD Sharing Statement

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Expiratory Flow Limitation Assessment

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