Effect of Different Ventilatory Strategies on Cardiac Function in Patients With Acute Respiratory Failure (VITALI)
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|ClinicalTrials.gov Identifier: NCT00713713|
Recruitment Status : Completed
First Posted : July 11, 2008
Last Update Posted : August 3, 2009
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).
|Condition or disease||Intervention/treatment||Phase|
|Respiratory Distress Syndrome||Procedure: Mechanical ventilation with low and high tidal volume||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||16 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Hemodynamic Impact of Low and High Tidal Volume Mechanical Ventilation in Acute Lung Injury (ALI)/Acute Respiratory Distress Syndrome (ARDS) Patients|
|Study Start Date :||July 2008|
|Actual Primary Completion Date :||May 2009|
|Actual Study Completion Date :||June 2009|
Two different tidal volumes (6 and 12 ml.kg-1 of ideal weight) are alternatively delivered to patients 30 minutes each one. The order of the two tidal volumes is randomized. Between the two study tidal volumes, patient returns for 30 minutes to the tidal volume used before the study recruitment.
Procedure: Mechanical ventilation with low and high tidal volume
Tidal volume of 6 or 12 ml.kg-1, calculated on ideal body weight
- cardiac index [ Time Frame: after 30 minutes of mechanical ventilation with tidal volume of 6 or 12 ml.kg-1 ]
- oxygen delivery [ Time Frame: after 30 minutes of mechanical ventilation with tidal volume of 6 or 12 ml.kg-1 ]
- oxygen consumption [ Time Frame: after 30 minutes of mechanical ventilation with tidal volume of 6 or 12 ml.kg-1 ]
- mixed venous saturation [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: after 30 minutes of mechanical ventilation with tidal volume of 6 or 12 ml.kg-1 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00713713
|Intensive Care Unit, Fondazione Poliambulanza Istituto Ospedaliero|
|Brescia, Italy, 25124|
|Principal Investigator:||Giuseppe Natalini, MD||Fondazione Poliambulanza Istituto Ospedaliero|