Trans-pulmonary Pressure in ARDS

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

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2017-04-13

Brief Summary

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Adequate PEEP selection in ARDS is still a matter of research. The main objectives of using PEEP in ARDS are improvement in oxygenation, lung recruitment at the end of expiration, prevention of opening and closing of terminal respiratory units at minimal hemodynamic compromise. The challenge is to carry out these objectives in a patient-centered approach based on individual characteristic of lung pathophysiology. Recently, it has been proposed to set PEEP from the trans-pulmonary end-expiratory pressure. Trans-pulmonary pressure (Ptp) is obtained from the difference between airway pressure and measured esophageal pressure (Pes). Measured Pes values have been found positive in the supine position in ARDS patients, leading to negative values of Ptp. The strategy proposed by Talmor and coworkers is to adjust PEEP up to get Ptp between 0 and 10 cm H2O. Whether this strategy improves survival is under investigation. Prone position ventilation significantly improves survival in severe ARDS as demonstrated by meta-analyses and a recent multicenter randomized controlled trial.

The purpose of present project is to investigate Ptp at end-expiration in the prone position in severe ARDS. The project is centered on the question about what are the values of measured Pes in prone position. The hypothesis is that they are lower than in the supine position due to the relief of the weight of heart, mediastinum and lung and also to recruitment of dorsal lung regions. To investigate this hypothesis, measured Pes, Ptp, end-expiratory lung volume, overall lung recruitment (pressure-volume curve), and regional recruitment by using electrical impedance tomography. will be assessed in supine then in the prone position across two different strategies of PEEP selection, PEEP/FIO2 table and Talmor proposal.

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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

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Prone Proseva

Group Type EXPERIMENTAL

level of positive end expiratory pressure (Prone Proseva)

Intervention Type DEVICE

PEEP based on PEEP/FIO2 table vs PEEP based on the value of oesophageal pressure

Prone Talmor

Group Type ACTIVE_COMPARATOR

level of positive end expiratory pressure (Prone Talmor)

Intervention Type DEVICE

PEEP based on PEEP/FIO2 table vs PEEP based on the value of oesophageal pressure

Interventions

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level of positive end expiratory pressure (Prone Proseva)

PEEP based on PEEP/FIO2 table vs PEEP based on the value of oesophageal pressure

Intervention Type DEVICE

level of positive end expiratory pressure (Prone Talmor)

PEEP based on PEEP/FIO2 table vs PEEP based on the value of oesophageal pressure

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* ARDS
* intubated
* indication of proning
* no contra-indication of proning

Exclusion Criteria

* contra-indication to proning
* contra-indication to esophageal balloon
* proning before
* end of life decision
* legal protection
* pregnancy
* ECMO

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No