search
Back to results

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

Primary Purpose

Acute Respiratory Distress Syndrome

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Tidal volume reduction to 4 ml/kg Predicted Body Weight (PBW)
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Respiratory Distress Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospices Civils de Lyon - Hôpital de la Croix Rousse

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Tidal volume 4 ml/kg Predicted Body Weight (PBW)

Arm Description

Outcomes

Primary Outcome Measures

Change in driving pressure
Driving pressure is the difference between total respiratory system plateau pressure minus total positive end-expiratory pressure (PEEP)

Secondary Outcome Measures

Rate of patients who achieved tidal volume reduction equal to 4 ml/kg predicted body weight
Rate of pneumothorax
Change in right ventricule/left ventricule area
Echographic measurement of right ventricule/left ventricule

Full Information

First Posted
June 24, 2016
Last Updated
July 19, 2018
Sponsor
Hospices Civils de Lyon
search

1. Study Identification

Unique Protocol Identification Number
NCT02816372
Brief Title
Ultra Protective Ventilation Without Extracorporeal Circulation in Severe ARDS Patients (VT4ARDS)
Acronym
VT4ARDS
Official Title
Ultra Protective Ventilation Without Extracorporeal Circulation in Severe ARDS Patients (VT4ARDS)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
October 2016 (Actual)
Primary Completion Date
June 14, 2018 (Actual)
Study Completion Date
June 14, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Distress Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tidal volume 4 ml/kg Predicted Body Weight (PBW)
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Tidal volume reduction to 4 ml/kg Predicted Body Weight (PBW)
Intervention Description
Tidal volume reduction to 4 ml/kg predicted body weight from inclusion to weaning PEEP trial
Primary Outcome Measure Information:
Title
Change in driving pressure
Description
Driving pressure is the difference between total respiratory system plateau pressure minus total positive end-expiratory pressure (PEEP)
Time Frame
Baseline and 24 hours following inclusion
Secondary Outcome Measure Information:
Title
Rate of patients who achieved tidal volume reduction equal to 4 ml/kg predicted body weight
Time Frame
48 hours following inclusion
Title
Rate of pneumothorax
Time Frame
Day 90
Title
Change in right ventricule/left ventricule area
Description
Echographic measurement of right ventricule/left ventricule
Time Frame
Baseline and 24 hours following inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Hospices Civils de Lyon - Hôpital de la Croix Rousse
City
Lyon
ZIP/Postal Code
69004
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs