Viewing Study NCT00236262



Ignite Creation Date: 2024-05-05 @ 12:04 PM
Last Modification Date: 2024-10-26 @ 9:20 AM
Study NCT ID: NCT00236262
Status: COMPLETED
Last Update Posted: 2007-03-26
First Post: 2005-10-07

Brief Title: Effect of Positive Expiratory Pressure on Right Ventricular Function in Patients With Respiratory Distress Syndrome
Sponsor: Assistance Publique - Hôpitaux de Paris
Organization: Assistance Publique - Hôpitaux de Paris

Study Overview

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
Status: COMPLETED
Status Verified Date: 2007-03
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: 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
Detailed Description: 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
PS040202 None None None