Clinical Trials Logo

Clinical Trial 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.

Clinical Trial 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 Design

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

Related Conditions & MeSH terms

NCT number NCT00236262
Study type Interventional
Source Assistance Publique - Hôpitaux de Paris
Status Completed
Phase N/A
Start date October 2005
Completion date September 2006

See also
  Status Clinical Trial Phase
Recruiting NCT01990456 - Strategies for Optimal Lung Ventilation in ECMO for ARDS: The SOLVE ARDS Study N/A
Completed NCT01167621 - Changes in Refractory Acute Respiratory Distress Syndrome (ARDS) Patients Under High Frequency Oscillation-ventilation N/A
Terminated NCT00233207 - IC14 Antibodies to Treat Individuals With Acute Lung Injury Phase 2
Completed NCT00029328 - Etanercept for Non-Infectious Lung Injury Following Bone Marrow Transplantation Phase 1/Phase 2
Recruiting NCT00004494 - Phase I Study of Vasoactive Intestinal Peptide in Patients With Acute Respiratory Distress Syndrome and Sepsis Phase 1
Completed NCT00000579 - Acute Respiratory Distress Syndrome Clinical Network (ARDSNet) Phase 3
Recruiting NCT03236272 - Establishment of a Biomarkers-based Early Warning System of Acute Respiratory Distress Syndrome (ARDS)
Completed NCT02273687 - Time-motion-mode Ultrasound Diaphragm Measures in Patients With Acute Respiratory Distress in Emergency Department N/A
Recruiting NCT03424798 - Measuring Heart and Lung Function in Critical Care N/A
Recruiting NCT01992237 - Measuring Energy Expenditure in ECMO (Extracorporeal Membrane Oxygenation) Patients N/A
Completed NCT00719446 - Evaluating Health Outcomes and QOL After ALI Among Participants of the ALTA, OMEGA, EDEN, and SAILS ARDS Network Trials N/A
Completed NCT00157144 - Australia and New Zealand Adult Extracorporeal Membrane Oxygenation (ECMO) Audit 2005 N/A
Completed NCT00300248 - Long-Term Results in Mechanically Ventilated Individuals With Acute Lung Injury/Acute Respiratory Distress Syndrome N/A
Completed NCT00141726 - Study of Enbrel (Etanercept) for the Treatment Sub-Acute Pulmonary Dysfunction After Allogeneic Stem Cell Transplant Phase 2
Recruiting NCT00465374 - A Validation/Interventional Study on Stress Index in Predicting Mechanical Stress in ARDS Patients Phase 3
Completed NCT00094406 - Carbon Monoxide to Prevent Lung Inflammation Phase 1
Recruiting NCT03709199 - Long Term Follow up of Children Enrolled in the REDvent Study
Unknown status NCT01716962 - Effects of Positive End-expiratory Pressure and Tidal Volume on Fluid Responsiveness of Acute Respiratory Distress Syndrome N/A
Recruiting NCT00605527 - Understanding the Role of Genes and Biomarkers in the Blood Clotting Process in Children With Acute Lung Injury N/A