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Effect of Positive Expiratory Pressure on Right Ventricular Function in Patients With Respiratory Distress Syndrome

Primary Purpose

Respiratory Distress Syndrome, Adult

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
ventilatory strategies with pressure
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Distress Syndrome, Adult focused on measuring SDRA, Distress, Expiratory, Pressure, Ventilatory

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • HOPITAL HENRI MONDOR Department of Neurosurgery

Outcomes

Primary Outcome Measures

Safety
Efficacy

Secondary Outcome Measures

Full Information

First Posted
October 7, 2005
Last Updated
March 23, 2007
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT00236262
Brief Title
Effect of Positive Expiratory Pressure on Right Ventricular Function in Patients With Respiratory Distress Syndrome
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 Type
Interventional

2. Study Status

Record Verification Date
March 2007
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Distress Syndrome, Adult
Keywords
SDRA, Distress, Expiratory, Pressure, Ventilatory

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Single
Allocation
Randomized
Enrollment
15 (false)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
ventilatory strategies with pressure
Primary Outcome Measure Information:
Title
Safety
Title
Efficacy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laurent BROCHARD, Pr,MD,PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
HOPITAL HENRI MONDOR Department of Neurosurgery
City
Creteil
ZIP/Postal Code
94010
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
16132889
Citation
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.
Results Reference
background
PubMed Identifier
16126933
Citation
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.
Results Reference
background
PubMed Identifier
19652953
Citation
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.
Results Reference
derived

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Effect of Positive Expiratory Pressure on Right Ventricular Function in Patients With Respiratory Distress Syndrome

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