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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00236262
Recruitment Status : Completed
First Posted : October 12, 2005
Last Update Posted : March 26, 2007
Information provided by:
Assistance Publique - Hôpitaux de Paris

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.

Condition or disease Intervention/treatment Phase
Respiratory Distress Syndrome, Adult Device: ventilatory strategies with pressure Not Applicable

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 : Interventional  (Clinical Trial)
Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single
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
Study Start Date : October 2005
Actual Study Completion Date : September 2006

Primary Outcome Measures :
  1. Safety
  2. Efficacy

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00236262

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

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00236262     History of Changes
Other Study ID Numbers: P040202
First Posted: October 12, 2005    Key Record Dates
Last Update Posted: March 26, 2007
Last Verified: March 2007

Keywords provided by Assistance Publique - Hôpitaux de Paris:

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