Expiratory Flow Limitation Assessment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-05

Study Completion Date

2019-05-02

Brief Summary

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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.

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Detailed Description

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Conditions

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Acute Respiratory Distress Syndrome

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Patients with EFL at PEP 5

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

Group Type OTHER

increase in positive end expiratory pressure

Intervention Type OTHER

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

Group Type OTHER

increase in positive end expiratory pressure

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No