ow-flow extra-corporeal CO2 removal and 4 mL/kg tidal volume vs. 6mL/kg tidal volume to enhance protection from ventilator induced lung injury in acute lung injury: a randomized multi-center trial

Conditions: Acute Respiratory Distress Syndrome
acute lung failure
10024967

Registration Number: NL-OMON37536

Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 18

Inclusion Criteria

- age > 18 years
- are on invasive assisted breathing less then 48 hours
- Less than 24 hours since diagnosis for ARDS: with PF<=200 and PEEP>=10, bilateral infiltrates on chest X-Ray and no clinical evidence of left artrial hypertension
- have a commitment to full support

Exclusion Criteria

- Intubation and mechanical ventilation for > 48 hours
- risk of systemic bleeding with anticoagulation
- acute brain injury
- body mass index >40
- Pregnancy

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary end-point:<br /><br>- Number of ventilator-free days during the 28 days immediatly after<br /><br>randomization.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary end-point:<br /><br>- 28-day all-cause mortality<br /><br>- 90-day all-cause mortality<br /><br>- Number of ICU-free days during the 28 days immediatly after randomization<br /><br>- Cumulative incidence of first episode of refractory hypoxemia (first 28 days)<br /><br>- Cumulative incidence of the use of rescue therapies<br /><br>- Cumulative incidence of first day that meet criteria for weaning readiness<br /><br>during 28 days after randomization<br /><br>- Cumulative SOFA-free score between randomization and day 28<br /><br>- Cumulatieve incidence of severe adverse events during 28 days after<br /><br>randomization</p><br>