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

NCT ID: NCT02816372

Last Updated: 2025-08-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-31
• Study Completion Date: 2018-06-14

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

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

Intervention Type: OTHER

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

Interventions

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hospices Civils de Lyon - Hôpital de la Croix Rousse

Lyon, , France

Countries

France

References

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.

Reference Type: RESULT

PMID: 31549225 (View on PubMed)

Other Identifiers

2016-A00503-48

Identifier Type: OTHER

Identifier Source: secondary_id

69HCL16_0082

Identifier Type: -

Identifier Source: org_study_id