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

NCT02816372 | Completed

• 2 other identifiers: 69HCL16_00822016-A00503-48
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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

Conditions

Acute Respiratory Distress Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

  Baseline and 24 hours following inclusion

Study Arms (1)

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

EXPERIMENTAL

Other: Tidal volume reduction to 4 ml/kg Predicted Body Weight (PBW)

Interventions

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

Tidal volume reduction to 4 ml/kg predicted body weight from inclusion to weaning PEEP trial

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hospices Civils de Lyon - Hôpital de la Croix Rousse

Lyon, 69004, France

Location

Related Publications (1)

• 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.

  PMID: 31549225 RESULT

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2016
• First Posted: June 28, 2016
• Study Start: October 1, 2016
• Primary Completion: June 14, 2018
• Study Completion: June 14, 2018
• Last Updated: August 8, 2025

Record last verified: 2025-08

Locations

FR (1)