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
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Mechanical ventilation with low and high tidal volume | Tidal 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.