Effect of Positive Expiratory Pressure on Right Ventricular Function in Patients With Respiratory Distress Syndrome
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|ClinicalTrials.gov Identifier: NCT00236262|
Recruitment Status : Completed
First Posted : October 12, 2005
Last Update Posted : March 26, 2007
|Condition or disease||Intervention/treatment||Phase|
|Respiratory Distress Syndrome, Adult||Device: ventilatory strategies with pressure||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|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|
|Study Start Date :||October 2005|
|Actual Study Completion Date :||September 2006|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00236262
|HOPITAL HENRI MONDOR Department of Neurosurgery|
|Creteil, France, 94010|
|Principal Investigator:||Laurent BROCHARD, Pr,MD,PhD||Assistance Publique - Hôpitaux de Paris|