Protective Ventilation With Carbon Dioxide (CO2) -Removal Technique in Patients With Adult Respiratory Distress Syndrome (ARDS)

University of Turin

Status and phase: Completed; Phase 3

Conditions: Adult Respiratory Distress Syndrome

Treatments: Procedure: protective ventilation with CO2 removal technique

Study type: Interventional

Funder types: Other

Identifiers

NCT00465309

PR60ANMA06

Details and patient eligibility

About

30% of ARDS patients ventilated according to NIH protocol presents morphological (CT) and functional (Stress Index>1) conditions of hyperinflation even with Plateau pressure (Pplat) < 30 cmH2O; values of Pplat lower than 26 cmH2O were associated with more a condition of more protective ventilation.

In patients at risk of hyperinflation, use of alternative techniques such as CO2-removal my allow the reduction of Tidal Volume (Vt) and Pplat.

Full description

Aim of the study was to verify the efficacy of CO2-removal technique in reducing Vt and consequently Pplat to obtain a Stress Index value equal to 1.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ARDS patients with Pplat >= 26 during NIH protective ventilation protocol

Exclusion criteria

• Age < 18 years
• Brain injury and patients with intracranial pressure > 20 mmHg
• Pregnancy
• Immunodepressed patients
• Patients already enrolled in other trials
• Renal replacement therapy
• BMI > 40
• Contraindication anticoagulation treatment
• Morphological abnormalities of femoral veins
• NYHA III-IV
• Burns BSA>30%
• Hepatic failure (grade C Child)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)