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

Acute Respiratory Distress Syndrome Clinical Trial

— VT4ARDS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02816372
• Other study ID #: 69HCL16_0082
• Secondary ID: 2016-A00503-48
• Status: Completed
• Phase: N/A
• Start date: October 2016
• Est. completion date: June 14, 2018

Study information

• Verified date: July 2018
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: June 14, 2018
• Est. primary completion date: June 14, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• invasive mechanical ventilation

• ARDS (Berlin definition) with PaO2/FiO2 ratio = 150 mm Hg

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

Related Conditions & MeSH terms

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

Intervention

Other:
• Tidal volume reduction to 4 ml/kg Predicted Body Weight (PBW)
Tidal volume reduction to 4 ml/kg predicted body weight from inclusion to weaning PEEP trial

Locations

Country	Name	City	State
France	Hospices Civils de Lyon - Hôpital de la Croix Rousse	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in driving pressure	Driving pressure is the difference between total respiratory system plateau pressure minus total positive end-expiratory pressure (PEEP)	Baseline and 24 hours following inclusion
Secondary	Rate of patients who achieved tidal volume reduction equal to 4 ml/kg predicted body weight		48 hours following inclusion
Secondary	Rate of pneumothorax		Day 90
Secondary	Change in right ventricule/left ventricule area	Echographic measurement of right ventricule/left ventricule	Baseline and 24 hours following inclusion