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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00465309
Enrollment
200
Registered
2007-04-25
Start date
2007-04-30
Completion date
2008-11-30
Last updated
2009-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adult Respiratory Distress Syndrome

Keywords

Respiratory Insufficiency, CO2 removal, protective ventilation, ARDS

Brief 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.

Detailed 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.

Interventions

PROCEDUREprotective 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.

Sponsors

Regione Piemonte
CollaboratorOTHER
University of Turin, Italy
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frame
pulmonary inflammatory mediator reductionwithin the first 72 hours after enrollment

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026