Echocardiography Predictive of the Inefficacy and/or of t... | NCT01768949

Status Module

Oversight Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Echocardiography	Device	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

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.	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.

Eligibility Module

Eligibility 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

Name	Affiliation	Role
Guillaume Besch	Centre Hospitalier Universitaire Besançon	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
CHU Besançon		Besançon		25000	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
5331459	Background	Morgan BC, Martin WE, Hornbein TF, Crawford EW, Guntheroth WG. Hemodynamic effects of intermittent positive pressure respiration. Anesthesiology. 1966 Sep-Oct;27(5):584-90. doi: 10.1097/00000542-196609000-00009. No abstract available.
1986678	Background	Fessler HE, Brower RG, Wise RA, Permutt S. Effects of positive end-expiratory pressure on the gradient for venous return. Am Rev Respir Dis. 1991 Jan;143(1):19-24. doi: 10.1164/ajrccm/143.1.19.

ID	Term
D057791	Cardiac Imaging Techniques
D003952	Diagnostic Imaging
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D014463	Ultrasonography
D006334	Heart Function Tests
D003935	Diagnostic Techniques, Cardiovascular