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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT01768949
• Date of registration: 13/01/2013
• Prospective Registration: Yes
• Primary sponsor: Centre Hospitalier Universitaire de Besancon
• Public title: Echocardiography Predictive of the Inefficacy and/or of the Unsafeness of Recruitment Maneuvers in Patients With Acute Respiratory Distress Syndrome. RV STAR
• Scientific title: Identification of Echocardiographic Criteria Predictive of the Inefficacy and/or the Unsafeness of Recruitment Maneuvers in Patients Suffering From Acute Respiratory Distress Syndrome
• Date of first enrolment: February 2013
• Target sample size: 30
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01768949
• Study type: Interventional
• Study design: Intervention model: Single Group Assignment. Primary purpose: Screening. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

France

Contacts

• Name: Guillaume Besch
• Affiliation: Centre Hospitalier Universitaire Besançon

Key inclusion & exclusion 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 ?uid 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Acute Respiratory Distress Syndrome

Intervention(s)

Device: Echocardiography

Primary Outcome(s)

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

Secondary Outcome(s)

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]

Comparison of the results of echocardiographic measurements between the group CONTROL and the group FAILURE. [Time Frame: 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]

Secondary ID(s)

P/2012/131

Source(s) of Monetary Support

Please refer to primary and secondary sponsors