Clinical trial NCT03462849: Expiratory Flow Limitation Assessment
Official title: Expiratory Fow Assessment in ARDS Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Respiratory Distress Syndrome
Keywords: ARDS
expiratory flow limitation
trans-pulmonary pressure
airway closure
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2018-03-13
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


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

Primary outcomes:
measure: EFL at PEP 5 cmH2O
timeFrame: at inclusion
Secondary outcomes:
measure: Trans-pulmonary pressure at end expiratory at PEP 5
timeFrame: at inclusion
measure: Trans-pulmonary pressure at end expiratory at PEP 10 in EFL and NFL patients
timeFrame: 15 minutes after PEP set to 10 cm H2O
measure: Lung compliance at PEP 10 in EFL and NFL patients
timeFrame: 15 minutes after PEP set to 10 cm H2O
measure: lung ventilation distribution at PEP 10 in EFL and NFL patients
timeFrame: 15 minutes after PEP set to 10 cm H2O
measure: Transcutaneous oxygen saturation (SpO2) at PEP 10 in EFL and NFL patients
timeFrame: 15 minutes after PEP set to 10 cm H2O
measure: Trans-pulmonary pressure at end expiratory at PEP 15 in EFL and NFL patients
timeFrame: 15 minutes after PEP set to 15 cm H2O
measure: Lung compliance at PEP 15 in EFL and NFL patients
timeFrame: 15 minutes after PEP set to 15 cm H2O
measure: lung ventilation distribution at PEP 15 in EFL and NFL patients
timeFrame: 15 minutes after PEP set to 15 cm H2O
measure: transcutaneous oxygen saturation (SpO2) at PEP 15 in EFL and NFL patients
timeFrame: 15 minutes after PEP set to 15 cm H2O
measure: Trans-pulmonary pressure at end expiratory at PEP to reach Trans-pulmonary pressure at end expiratory =+3 cmH2O in EFL and NFL patients
timeFrame: 15 minutes after PEP set to reach Trans-pulmonary pressure at end expiratory =+3 cmH2O
measure: Lung compliance at PEP to reach Trans-pulmonary pressure at end expiratory =+3 cmH2O in EFL and NFL patients
timeFrame: 15 minutes after PEP set to reach Trans-pulmonary pressure at end expiratory =+3 cmH2O
measure: lung ventilation distribution at PEP set to reach Trans-pulmonary pressure at end expiratory =+3 cmH2O in EFL and NFL patients
timeFrame: 15 minutes after PEP set to reach Trans-pulmonary pressure at end expiratory =+3 cmH2O
measure: Transcutaneous oxygen saturation (SpO2) at PEEP set to reach Trans-pulmonary pressure at end expiratory =+3 cmH2O in EFL and NFL patients
timeFrame: 15 minutes after PEEP set to reach Trans-pulmonary pressure at end expiratory =+3 cmH2O
measure: lung recruitment at PEEP 10 in EFL and NFL patients
timeFrame: 15 minutes after PEEP set to 10 cm H2O
measure: lung recruitment at PEEP 15 in EFL and NFL patients
timeFrame: 15 minutes after PEEP set to 15 cm H2O
measure: 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
timeFrame: 15 minutes after PEEP set to 15 cm H2O
Other outcomes:
Locations:
city: Grenoble
country: France
facility: CHU Grenoble Alpes
city: Lyon
country: France
facility: Hôpital de la Croix Rousse
Study officials:
affiliation: Hospices Civils de Lyon
name: Claude Guerin, Pr
role: PRINCIPAL_INVESTIGATOR
References: