NCT00236262

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

October 7, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 12, 2005

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
Last Updated

March 26, 2007

Status Verified

March 1, 2007

First QC Date

October 7, 2005

Last Update Submit

March 23, 2007

Conditions

Keywords

SDRADistressExpiratoryPressureVentilatory

Outcome Measures

Primary Outcomes (2)

  • Safety

  • Efficacy

Interventions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Age \<18 years
  • Pregnancy
  • Obstructive chronic broncho-pneumonopathy
  • Suspected or confirmed intracranial hypertension
  • Pneumothorax
  • Evolutionary oesophageal pathology
  • PaO2/FiO2 Report/ratio \< 50 mmHg
  • Amount of adrenaline or noradrenaline higher than 2 mg/hour

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HOPITAL HENRI MONDOR Department of Neurosurgery

Créteil, 94010, France

Location

Related Publications (3)

  • 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.

    PMID: 16132889BACKGROUND
  • 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.

    PMID: 16126933BACKGROUND
  • 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.

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration Disorders

Study Officials

  • Laurent BROCHARD, Pr,MD,PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 7, 2005

First Posted

October 12, 2005

Study Start

October 1, 2005

Study Completion

September 1, 2006

Last Updated

March 26, 2007

Record last verified: 2007-03

Locations