- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00236262
Effect of Positive Expiratory Pressure on Right Ventricular Function in Patients With Respiratory Distress Syndrome
Effect of the Positive Expiratory Pressure on the Right Ventricular Function in Patient With Adult Respiratory Distress Syndrome Ventilated With Limited Plateau Pressure
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Creteil, France, 94010
- HOPITAL HENRI MONDOR Department of Neurosurgery
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Intubation and artificial ventilation
- Bilateral pulmonary opacities radiological compatible with an organic pulmonary oedema
- PaO2/FiO2 report/ratio < 200 mmHg
- Not obviously clinical or echocardiographic of rise in the pressure of ventricular filling left
- Joint presence of criteria 2, 3 and 4 since less than 72 hours
Exclusion Criteria:
- Age <18 years
- Pregnancy
- Obstructive chronic broncho-pneumonopathy
- Suspected or confirmed intracranial hypertension
- Pneumothorax
- Evolutionary oesophageal pathology
- Hemodynamic instability with need of filling vascular or modification of posology of the vasopressors in the 2 hours preceding inclusion
- PaO2/FiO2 Report/ratio < 50 mmHg
- Amount of adrenaline or noradrenaline higher than 2 mg/hour
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Safety
|
Efficacy
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Collaborators and Investigators
Investigators
- Principal Investigator: Laurent BROCHARD, Pr,MD,PhD, Assistance Publique - Hôpitaux de Paris
Publications and helpful links
General Publications
- Bouadma L, Lellouche F, Cabello B, Taille S, Mancebo J, Dojat M, Brochard L. Computer-driven management of prolonged mechanical ventilation and weaning: a pilot study. Intensive Care Med. 2005 Oct;31(10):1446-50. doi: 10.1007/s00134-005-2766-2. Epub 2005 Aug 23.
- Lacherade JC, Auburtin M, Cerf C, Van de Louw A, Soufir L, Rebufat Y, Rezaiguia S, Ricard JD, Lellouche F, Brun-Buisson C, Brochard L. Impact of humidification systems on ventilator-associated pneumonia: a randomized multicenter trial. Am J Respir Crit Care Med. 2005 Nov 15;172(10):1276-82. doi: 10.1164/rccm.200408-1028OC. Epub 2005 Aug 26.
- Mekontso Dessap A, Charron C, Devaquet J, Aboab J, Jardin F, Brochard L, Vieillard-Baron A. Impact of acute hypercapnia and augmented positive end-expiratory pressure on right ventricle function in severe acute respiratory distress syndrome. Intensive Care Med. 2009 Nov;35(11):1850-8. doi: 10.1007/s00134-009-1569-2. Epub 2009 Aug 4.
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- P040202
- PS040202
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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