NCT01768949

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2013

Longer than P75 for not_applicable

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

First Submitted

Initial submission to the registry

January 13, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 16, 2013

Completed
16 days until next milestone

Study Start

First participant enrolled

February 1, 2013

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

January 31, 2017

Status Verified

January 1, 2017

Enrollment Period

3.9 years

First QC Date

January 13, 2013

Last Update Submit

January 30, 2017

Conditions

Keywords

Acute respiratory distress syndromeEchocardiographyRecruitment maneuver

Outcome Measures

Primary Outcomes (1)

  • Efficacy and safety of recruitment maneuvers in patients with Acute Respiratory Distress Syndrome.

    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 Outcomes (3)

  • Feasibility of the measurement of Longitudinal Strain and Strain Rate of the right ventricle in patients suffering from Acute Respiratory Distress Syndrome.

    Up to 2 years

  • Comparison of the results of echocardiographic measurements between the group CONTROL and the group FAILURE.

    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.

    Up to 2 years

Study Arms (1)

Echocardiography

OTHER

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

Interventions

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.

Echocardiography

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Besançon

Besançon, 25000, France

Location

Related Publications (54)

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MeSH Terms

Conditions

Respiratory Distress Syndrome

Interventions

Echocardiography

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration Disorders

Intervention Hierarchy (Ancestors)

Cardiac Imaging TechniquesDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisUltrasonographyHeart Function TestsDiagnostic Techniques, Cardiovascular

Study Officials

  • Guillaume Besch

    Centre Hospitalier Universitaire Besançon

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

January 13, 2013

First Posted

January 16, 2013

Study Start

February 1, 2013

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

January 31, 2017

Record last verified: 2017-01

Locations