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

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.

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Key information

Conditions

Adult Respiratory Distress Syndrome Lung Diseases Respiration Disorders Respiratory Distress Syndrome Respiratory Insufficiency Respiratory Tract Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

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

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

protective ventilation with CO2 removal technique

Procedure

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.

Primary outcomes

pulmonary inflammatory mediator reduction

Time frame: within the first 72 hours after enrollment

Sponsors and collaborators

Lead sponsor

University of Turin, Italy

Other

Collaborators

Regione Piemonte

Registry information

Important dates

Study start: 2007
Study completion: 2008
First posted: Apr 25, 2007
Registry last updated: Jan 12, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed