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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Centre Hospitalier Universitaire de Besancon
Sponsor:
Information provided by (Responsible Party):
Loubena ASSILA, Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier:
NCT01768949
First received: January 13, 2013
Last updated: February 8, 2013
Last verified: February 2013
  Purpose

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


Condition Intervention
Acute Respiratory Distress Syndrome
Device: Echocardiography

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Screening
Official Title: Identification of Echocardiographic Criteria Predictive of the Inefficacy and/or the Unsafeness of Recruitment Maneuvers in Patients Suffering From Acute Respiratory Distress Syndrome

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Besancon:

Primary Outcome Measures:
  • Efficacy and safety of recruitment maneuvers in patients with Acute Respiratory Distress Syndrome. [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]

    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 ?



Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

    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.


  • Comparison of the results of echocardiographic measurements between the group CONTROL and the group FAILURE. [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
    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

  • 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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 50
Study Start Date: February 2013
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01768949

Contacts
Contact: Guillaume Besch 03 81 66 81 30 ext 00333 81 66 81 guillaume.besch@gmail.com

Locations
France
Centre Hospitalier Universitaire de Besançon Not yet recruiting
Besancon, France, 25000
Contact: Besch Guillaume    03 81 66 81 30 ext 00333 81 66 81    guillaume.besch@gmail.com   
CHU Besançon Recruiting
Besançon, France, 25000
Principal Investigator: Guillaume Besch         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Besancon
Investigators
Study Director: Guillaume Besch Centre Hospitalier Universitaire Besançon
  More Information

Publications:

Responsible Party: Loubena ASSILA, Intern, Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier: NCT01768949     History of Changes
Other Study ID Numbers: u3vm62ir
Study First Received: January 13, 2013
Last Updated: February 8, 2013
Health Authority: France: Institutional Ethical Committee

Keywords provided by Centre Hospitalier Universitaire de Besancon:
Acute respiratory distress syndrome
Echocardiography
Recruitment maneuver

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 20, 2014