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Completed

NCT Number: NCT02816372

Ultra Protective Ventilation Without Extracorporeal Circulation in Severe ARDS Patients (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

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Key information

Conditions

Acute Respiratory Distress Syndrome Lung Diseases Respiration Disorders Respiratory Distress Syndrome Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospices Civils de Lyon - Hôpital de la Croix Rousse

Lyon, 69004, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Change in driving pressure

    Time frame: 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 outcomes

  1. Rate of patients who achieved tidal volume reduction equal to 4 ml/kg predicted body weight

    Time frame: 48 hours following inclusion

  2. Rate of pneumothorax

    Time frame: Day 90

  3. Change in right ventricule/left ventricule area

    Time frame: Baseline and 24 hours following inclusion

    Echographic measurement of right ventricule/left ventricule

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Acronym: VT4ARDS

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jun 28, 2016
Registry last updated
Aug 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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