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

This study has been completed.
Sponsor:
Information provided by:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00236262
First received: October 7, 2005
Last updated: March 23, 2007
Last verified: March 2007
  Purpose

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.


Condition Intervention
Respiratory Distress Syndrome, Adult
Device: ventilatory strategies with pressure

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Safety
  • Efficacy

Estimated Enrollment: 15
Study Start Date: October 2005
Study Completion Date: September 2006
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Intubation and artificial ventilation
  2. Bilateral pulmonary opacities radiological compatible with an organic pulmonary oedema
  3. PaO2/FiO2 report/ratio < 200 mmHg
  4. Not obviously clinical or echocardiographic of rise in the pressure of ventricular filling left
  5. Joint presence of criteria 2, 3 and 4 since less than 72 hours

Exclusion Criteria:

  1. Age <18 years
  2. Pregnancy
  3. Obstructive chronic broncho-pneumonopathy
  4. Suspected or confirmed intracranial hypertension
  5. Pneumothorax
  6. Evolutionary oesophageal pathology
  7. Hemodynamic instability with need of filling vascular or modification of posology of the vasopressors in the 2 hours preceding inclusion
  8. PaO2/FiO2 Report/ratio < 50 mmHg
  9. Amount of adrenaline or noradrenaline higher than 2 mg/hour
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00236262

Locations
France
HOPITAL HENRI MONDOR Department of Neurosurgery
Creteil, France, 94010
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Laurent BROCHARD, Pr,MD,PhD Assistance Publique - Hôpitaux de Paris
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00236262     History of Changes
Other Study ID Numbers: P040202, PS040202
Study First Received: October 7, 2005
Last Updated: March 23, 2007
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
SDRA
Distress
Expiratory
Pressure
Ventilatory

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury

ClinicalTrials.gov processed this record on July 31, 2014