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Clinical Trials/NCT00713713
NCT00713713
Completed
Not Applicable

Hemodynamic Impact of Low and High Tidal Volume Mechanical Ventilation in Acute Lung Injury (ALI)/Acute Respiratory Distress Syndrome (ARDS) Patients

Fondazione Poliambulanza Istituto Ospedaliero1 site in 1 country16 target enrollmentJuly 2008

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Respiratory Distress Syndrome
Sponsor
Fondazione Poliambulanza Istituto Ospedaliero
Enrollment
16
Locations
1
Primary Endpoint
cardiac index
Status
Completed
Last Updated
16 years ago

Overview

Brief Summary

Mechanical ventilation with low tidal volume (about 6 ml.kg-1) reduces mortality in ALI/ARDS patients respect to high tidal volume ventilation (about 12 ml.kg-1).

This finding is usually explained by alveolar tidal overdistension associated to high tidal volume. Stretch-induced lung injury may trigger a cytokine-mediated inflammatory response. This may contribute to the development of systemic inflammatory response and multiple system organ failure and death.

High tidal volume strategies might affect organ function by pathways not mediated by inflammatory response.

It is well recognized the inverse relationship between tidal volume and cardiac output during mechanical ventilation. Nevertheless there are no clinical studies about cardiac output changes induced by low (6 ml.kg-1) and high tidal volume (12 ml.kg-1) in ALI/ARDS patients.

The study hypothesis is that high tidal volume ventilation reduces cardiac output in ALI/ARDS patients respect to low tidal volume strategy. Thereafter reduced hemodynamic impact could explain beneficial effect of low respect to high tidal volume ventilation.

If study hypothesis is confirmed, other studies should define the main cause of mortality reduction related to low tidal volume strategies and if appropriate hemodynamic monitoring and support should be required when low tidal volume strategies are harmful (i.e. traumatic brain injury).

Registry
clinicaltrials.gov
Start Date
July 2008
End Date
June 2009
Last Updated
16 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
Fondazione Poliambulanza Istituto Ospedaliero

Eligibility Criteria

Inclusion Criteria

  • diagnosis of ARDS/ALI

Exclusion Criteria

  • mean arterial pressure lower than 65 mmHg
  • beginning or change of vasoactive agents infusion rate in the last 2 hours

Outcomes

Primary Outcomes

cardiac index

Time Frame: after 30 minutes of mechanical ventilation with tidal volume of 6 or 12 ml.kg-1

Secondary Outcomes

  • oxygen delivery(after 30 minutes of mechanical ventilation with tidal volume of 6 or 12 ml.kg-1)
  • oxygen consumption(after 30 minutes of mechanical ventilation with tidal volume of 6 or 12 ml.kg-1)
  • mixed venous saturation(after 30 minutes of mechanical ventilation with tidal volume of 6 or 12 ml.kg-1)
  • relationship between partitioned elastance (lung and chest wall) and cardiac index difference between ventilation with tidal volume 6 and 12 ml.kg-1(after 30 minutes of mechanical ventilation with tidal volume of 6 or 12 ml.kg-1)
  • abdominal perfusion pressure (mean arterial pressure minus abdominal pressure)(after 30 minutes of mechanical ventilation with tidal volume of 6 or 12 ml.kg-1)

Study Sites (1)

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