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

Acute Respiratory Distress Syndrome Clinical Trial

— RV STAR  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01768949
• Other study ID #: P/2012/131
• Status: Completed
• Phase: N/A
• First received: January 13, 2013
• Last updated: January 30, 2017
• Start date: February 2013
• Est. completion date: January 2017

Study information

• Verified date: January 2017
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
France	CHU Besançon	Besançon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

References & Publications (54)

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* Note: There are 54 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Up to 2 years
Secondary	Comparison of the results of echocardiographic measurements between the group CONTROL and the group FAILURE.	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
Secondary	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.	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