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Flow-flow ECCO2-R and 4 ml/kg Tidal Volume vs. 6 ml/kg Tidal Volume to Enhance Protection From VILI in Acute Lung Injury

NCT01522599 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 230

Last updated 2014-06-17

No results posted yet for this study

Summary

The main objective of this randomized multicenter clinical trial is to test the hypothesis that further reduction of VT to 4mL/kg may enhance lung protection in patients with ARDS as compared to the conventional "ARDS-Net" ventilation. Control of PaCO2 in the \~4 ml/kg arm would be accomplished by LFPPV- ECCO2-R.

Conditions

  • Acute Respiratory Distress Syndrome

Interventions

OTHER

ARDS-Net Strategy

Treatment according to the ARDS-Net protocol (The Acute Respiratory Distress Syndrome Network N Engl J Med 2000; 342:1301-1308May 4, 2000)

OTHER

ECCO2-R

Ventilation with Tidal Volume of 4 ml/kg PBW and low flow CO2 removal

Sponsors & Collaborators

  • University of Turin, Italy

    lead OTHER

Principal Investigators

  • Vito Marco VM Ranieri, MD · Department of Anesthesia and Intensive Care Medicine, University of Turin, Italy

  • Antonio A Pesenti, MD · Department of Perioperative Medicine and Intensive Care, San Gerardo Hospital, Monza, Italy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2014-01-31
Completion
2014-01-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01522599 on ClinicalTrials.gov