Respiratory Distress Syndrome, Adult Clinical Trial
Official title:
Effect of the Positive Expiratory Pressure on the Right Ventricular Function in Patient With Adult Respiratory Distress Syndrome Ventilated With Limited Plateau Pressure
The objective of this study is to analyze by trans-oesophageal echocardiography the effect on the right ventricle of positive expiratory pressure (PEP) level variations with constant plate pressure among patients with syndrome of acute respiratory distress of the adult (SDRA). The assumption tested is that a high level of PEP increases the impedance with the ejection of the right ventricle independently of the level of plate pressure. The effect on the right ventricular preload will be checked via the analysis of the respiratory variability of the diameter of the higher vena cava.
Background: The ventilatory strategy in patients with Adult Respiratory Distress Syndrome
(ARDS) is still controversial concerning the finest level of positive expiratory pressure
(PEP). In fact, PEP allows optimisation of lung recruitment and oxygenation. However, high
PEP may be detrimental on hemodynamics, notably impairing filling and ejection of the right
ventricle (RV). At present, it is not known whether these adverse effects of PEP are
independent or not of plateau pressure.
Objectives: The aim of the present study is to explore the effect of PEP variations (with
constant plateau pressure) on RV function (assessed using trans-oesophageal
echocardiography, TOE) in patients with ARDS. The assumption tested is that a high level of
PEP increases the impedance to RV ejection independently of the level of plateau pressure.
The effect of PEP on the right ventricular preload will also be checked via the analysis of
the respiratory variability of the diameter of superior vena cava. Respiratory system
properties will be assessed as follows: alveolar dead space determination using expired CO2,
alveolar recruitment calculation using pressure-volume curves.
Methods: The patients are ventilated according to three consecutive strategies (A, B and C),
using the same plateau pressure (<30 cm H2O), but different PEP levels: low PEP in strategy
A and high PEP in strategies B and C. In order to maintain a constant plateau pressure, the
increase in PEP level in strategies B and C is accompanied by a decrease in tidal volume.
This decrease in tidal volume is compensated by an increase in respiratory frequency
(strategy B) or a decrease of instrumental dead space by removal of heat and moisture
exchanger filter (strategy C).
The first ventilatory strategy tested is “A”. After that, the patient is randomised for
strategies “B then C”, or “C then B”. At the end of each strategies the following
explorations are performed: TOE, respiratory system pressure-volume curves, expired CO2
analysis, and arterial blood gas analysis.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Treatment
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