Echocardiography Predictive of the Inefficacy and/or of the Unsafeness of Recruitment Maneuvers in Patients With Acute Respiratory Distress Syndrome. (RV STAR)

January 30, 2017 updated by: Guillaume BESCH, Centre Hospitalier Universitaire de Besancon

Identification of Echocardiographic Criteria Predictive of the Inefficacy and/or the Unsafeness of Recruitment Maneuvers in Patients Suffering From Acute Respiratory Distress Syndrome

The purpose of the study RVSTAR is to evaluate whether echocardiographic criteria exploring the right ventricle can predict the inefficacy and/or the unsafeness of recruitment maneuvers in patients suffering from acute respiratory distress syndrome

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Besançon, France, 25000
        • CHU Besançon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Endotracheal mechanical ventilation for acute hypoxemic respiratory failure lasting for one week or less
  • A ratio of the partial pressure of arterial oxygen (PaO2 measured in millimeters of mercury) to the fraction of inspired oxygen (FiO2 which is unitless) of 300 mmHg or less and inspired fraction of oxygen FiO2 of more than 50 %
  • A positive end-expiratory pressure of 5 cm of water or higher
  • A tidal volume of 6 to 8 ml per kilogram of predicted body weight
  • Bilateral opacities on chest radiography not fully explained by effusions, lobar/lung collapse, or nodules
  • Respiratory failure not fully explained by cardiac failure or fluid overload
  • Written and informed consent
  • Adult patients at least 18 years of age
  • Ventilatory criteria (PaO2/FiO2 of 300 mmHg or less and Positive End Expiratory Pressure of 5 cm of water or higher) and radiologic criteria (Bilateral opacities on chest radiography not fully explained by effusions, lobar/lung collapse, or nodules) lasting more than 24 hours

Exclusion Criteria:

  • Endotracheal mechanical ventilation for acute hypoxemic respiratory failure lasting for more than one week
  • Age younger than 18 years old
  • No written and informed consent
  • Known pregnancy and/or breastfeeding
  • Increased intracranial pressure
  • A ratio of the partial pressure of arterial oxygen (PaO2 measured in millimeters of mercury) to the fraction of inspired oxygen (FiO2 which is unitless) higher than 300 mmHg
  • Positive end expiratory pressure of less than 5 mmHg
  • Ventilatory criteria (PaO2/FiO2 of 300 mmHg or less and Positive End Expiratory Pressure of 5 cm of water or higher) and radiologic criteria (Bilateral opacities on chest radiography not fully explained by effusions, lobar/lung collapse, or nodules) lasting less than 24 hours
  • Severe chronic respiratory disease requiring long-term oxygen therapy or mechanical ventilation at home
  • Severe chronic liver disease
  • Barotrauma such as pneumothorax
  • Hemodynamic failure needing more than 3 milligrams per hour of noradrenalin and/or more than 2 milligrams per hour of adrenalin and or rising doses of vasopressors and/or vascular filling exceeding 500 milliliters in the preceding hour
  • Arrhythmias such as : ventricular tachycardia, ventricular fibrillation, third degree atrioventricular block
  • Atrial fibrillation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Echocardiography
An echocardiography will be systematically realised in all the patients included in the study in order to evaluate whether any echocardiographic criterion exploring the right ventricle can predict the efficacy and/or safeness of recruitment maneuvers in patients suffering from acute respiratory distress syndrome.
Device: Echocardiography
In the study RVSTAR, all the patients included will undergo an echocardiography in order to find an echocardiographic criterion predictive of the inefficacy and/or unsafeness of recruitment maneuver.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy and safety of recruitment maneuvers in patients with Acute Respiratory Distress Syndrome.
Time Frame: Up to 2 years

A recruitment maneuver is considered effective if the partial pressure of oxygen in arterial blood PaO2 measured one hour after the completion of recruitment maneuver is 20 % higher than PaO2 before recruitment maneuver.

A recruitment maneuver is considered unsafe if systolic arterial pressure decreases 40 % under its value before recruitment maneuver and/or if systolic arterial pressure decreases under 70 mmHg and/or if arrhythmias (third degree atrio-ventricular block, ventricular tachycardia, ventricular fibrillation, atrial fibrillation)occur during the achievement of recruitment maneuver in patients suffering from Acute Respiratory Distress Syndrome.

Can echocardiography predict the inefficacy and/or unsafeness of recruitment maneuvers in patients suffering from Acute Respiratory Distress Syndrom ?
Up to 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of the measurement of Longitudinal Strain and Strain Rate of the right ventricle in patients suffering from Acute Respiratory Distress Syndrome.
Time Frame: Up to 2 years

Collecting echocardiographic criteria exploring the right ventricle is particularly difficult, especially in patients suffering from Acute Respiratory Distress Syndrome.

One of the aims of the study RVSTAR is to evaluate if the measurement of Longitudinal Strain and Strain Rate of the right ventricle is feasible.

At the end of the study, the feasibility of the measurement of Longitudinal Strain and Strain Rate of the right ventricle will be determined by the proportion of patients (among all the patients included) in whom these echocardiographic criteria (Longitudinal Strain and Strain Rate of the right ventricle) have been realised successfully.
Up to 2 years
Comparison of the results of echocardiographic measurements between the group CONTROL and the group FAILURE.
Time Frame: Up to 2 years
Is there any statistical difference in the echocardiographic measurements exploring the right ventricle in the group CONTROL (the recruitment maneuver has been safe and effective) and the group FAILURE (the recruitment maneuver has not been safe and /or has not been effective)? The echocardiographic measurements assessed (and compared between the 2 groups) will be the following ones : right heart dimensions (diameter at the base and at the mid-level of the right ventricle, longitudinal dimension of the right ventricle), right ventricle wall thickness, tricuspid annular plane systolic excursion, two-dimensional fractional area change, two-dimensional right ventricle ejection fraction,tissue Doppler-derived tricuspid lateral annular systolic velocity, longitudinal strain and strain rate, pulsed Doppler of the tricuspid inflow, tissue Doppler of the lateral tricuspid annulus, pulsed Doppler of the hepatic vein, measurements of inferior vena cava, tricuspid regurgitation velocity
Up to 2 years
Evaluate the effect of the inefficacy and/or of the unsafeness of the recruitment maneuver on the future of the patient suffering from Acute Respiratory Distress Syndrome.
Time Frame: Up to 2 years
One of the aims of the study RVSTAR is to evaluate if there is an effect of the inefficacy and/or the unsafeness of the recruitment maneuver on mortality (proportion of patients who died within 30 days after study enrollment), on the duration of invasive mechanical ventilation (number of days under mechanical ventilation from the study enrollment until discharge from the intensive care unit), on the length of stay in the intensive care unit (number of days spent in the intensive care unit) and on organ failure (renal failure defined by the need for renal replacement therapy, hemodynamic failure defined by the need for vascular filling exceeding 50 ml per kilogram of body weight and/or the need for vasopressors and/or for the need for rising doses of vasopressors) in patients suffering from Acute Respiratory Distress Syndrome.
Up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Besancon

Investigators

  • Study Director: Guillaume Besch, Centre Hospitalier Universitaire Besançon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Actual)

January 1, 2017

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

January 13, 2013

First Submitted That Met QC Criteria

January 14, 2013

First Posted (Estimate)

January 16, 2013

Study Record Updates

Last Update Posted (Estimate)

January 31, 2017

Last Update Submitted That Met QC Criteria

January 30, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P/2012/131

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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