Ultra Protective Ventilation Without Extracorporeal Circulation in Severe ARDS Patients (VT4ARDS)

Not Applicable

Completed

• Conditions: Acute Respiratory Distress Syndrome
• Interventions: Other: Tidal volume reduction to 4 ml/kg Predicted Body Weight (PBW)

• Registration Number: NCT02816372
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

Despite the use of protective ventilation, neuromuscular blocking agent and prone position, ARDS mortality remains high (30%-50%) in observational studies, and pneumothorax rate in randomized controlled trial remains stable (10%). The driving pressure (the ratio of tidal volume over respiratory system compliance) has recently been strongly associated with ARDS mortality, suggesting that tidal volume reduction below 6ml/kg may offer mortality benefit. While extracorporeal CO2 removal technique are currently under investigation in association with tidal volume reduction

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2016-06-24
• Study First Submitted QC: 2016-06-24
• Study First Posted: 2016-06-28
• Study Start: 2016-10
• Primary Completion: 2018-06-14
• Study Completion: 2018-06-14
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-19
• Last Update Posted: 2018-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

Inclusion Criteria

• invasive mechanical ventilation
• ARDS (Berlin definition) with PaO2/FiO2 ratio ≤ 150 mm Hg

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Exclusion Criteria

• Age below 18 year
• planned duration of invasive mechanical ventilation < 48 hours
• ARDS criteria present for more than 24 hours
• known or suspected intracranial hypertension
• known or suspected COPD
• chronic respiratory failure under long term oxygen or non-invasive ventilation
• pneumothorax or broncho-pleural fistula
• morbid obesity with body weight >1 kg/cm height
• sickle cell disease
• recent bone marrow transplantation, aplasia following chemotherapy
• burn injury on more than 30% of body surface
• severe hepatic cirrhosis (Child-Pugh score C)
• extracorporeal circulation life support
• pregnancy
• advance directives to withhold or withdraw life-sustaining treatment
• previous inclusion in present study
• patient under an exclusion period following inclusion in another biomedical study
• patient deprived of freedom, minor, subject under a legal protective measure
• lack of affiliation to social security as required by French regulation
• lack of written informed consent by patient or next of kin

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tidal volume 4 ml/kg Predicted Body Weight (PBW)	Tidal volume reduction to 4 ml/kg Predicted Body Weight (PBW)	-

Primary Outcome Measures

Name	Time	Method
Change in driving pressure	Baseline and 24 hours following inclusion	Driving pressure is the difference between total respiratory system plateau pressure minus total positive end-expiratory pressure (PEEP)

Secondary Outcome Measures

Name	Time	Method
Rate of pneumothorax	Day 90
Change in right ventricule/left ventricule area	Baseline and 24 hours following inclusion	Echographic measurement of right ventricule/left ventricule
Rate of patients who achieved tidal volume reduction equal to 4 ml/kg predicted body weight	48 hours following inclusion

Trial Locations

Locations (1)

Hospices Civils de Lyon - Hôpital de la Croix Rousse; 🇫🇷 Lyon, France