Clinical Trials Directory

Trials / Completed

CompletedNCT00713713

Effect of Different Ventilatory Strategies on Cardiac Function in Patients With Acute Respiratory Failure

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
16 (estimated)
Sponsor
Fondazione Poliambulanza Istituto Ospedaliero · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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).

Conditions

Interventions

TypeNameDescription
PROCEDUREMechanical ventilation with low and high tidal volumeTidal volume of 6 or 12 ml.kg-1, calculated on ideal body weight

Timeline

Start date
2008-07-01
Primary completion
2009-05-01
Completion
2009-06-01
First posted
2008-07-11
Last updated
2009-08-03

Locations

1 site across 1 country: Italy

Source: ClinicalTrials.gov record NCT00713713. Inclusion in this directory is not an endorsement.