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

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

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Lyon, France, 69004
    • Hospices Civils de Lyon - Hôpital de la Croix Rousse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tidal volume 4 ml/kg Predicted Body Weight (PBW)	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Publications and helpful links

General Publications

• Richard JC, Marque S, Gros A, Muller M, Prat G, Beduneau G, Quenot JP, Dellamonica J, Tapponnier R, Soum E, Bitker L, Richecoeur J; REVA research network. Feasibility and safety of ultra-low tidal volume ventilation without extracorporeal circulation in moderately severe and severe ARDS patients. Intensive Care Med. 2019 Nov;45(11):1590-1598. doi: 10.1007/s00134-019-05776-x. Epub 2019 Sep 23.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2016
• Primary Completion (Actual): June 14, 2018
• Study Completion (Actual): June 14, 2018

Study Registration Dates

• First Submitted: June 24, 2016
• First Submitted That Met QC Criteria: June 24, 2016
• First Posted (Estimated): June 28, 2016

Study Record Updates

• Last Update Posted (Actual): August 8, 2025
• Last Update Submitted That Met QC Criteria: August 5, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Respiration Disorders; Infant, Premature, Diseases; Infant, Newborn, Diseases; Lung Injury; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
• Other Study ID Numbers: 69HCL16_0082; 2016-A00503-48 (Other Identifier: ANSM)