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

Adult Respiratory Distress Syndrome Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00465309
• Other study ID #: PR60ANMA06
• Status: Completed
• Phase: Phase 3
• First received: April 24, 2007
• Last updated: January 9, 2009
• Start date: April 2007
• Est. completion date: November 2008

Study information

• Verified date: January 2009
• Source: University of Turin, Italy
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Lung Injury
• Adult Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn

Intervention

Procedure:
• protective ventilation with CO2 removal technique
In ARDS patients, presenting a Pplat = 26 cmH2O, Vt was lowered (reaching a Pplat < 26) with CO2-removal veno-venous pump-driven bypass support for 48 consecutive hours with a pH > 7,30 or at least 72 hours from the beginning of the extracorporeal treatment.

Locations

Country	Name	City	State
Italy	University of Turin, Department of Anesthesia and Intensive Care Medicine	Turin
Italy	University of Turin, Department of Anesthesia and Intensive Care Medicine,S. G. Battista Hospital	Turin

Sponsors (2)

Lead Sponsor	Collaborator
University of Turin, Italy	Regione Piemonte

Country where clinical trial is conducted

Italy, 

References & Publications (1)

Terragni PP, Rosboch G, Tealdi A, Corno E, Menaldo E, Davini O, Gandini G, Herrmann P, Mascia L, Quintel M, Slutsky AS, Gattinoni L, Ranieri VM. Tidal hyperinflation during low tidal volume ventilation in acute respiratory distress syndrome. Am J Respir Crit Care Med. 2007 Jan 15;175(2):160-6. Epub 2006 Oct 12. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pulmonary inflammatory mediator reduction		within the first 72 hours after enrollment