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

This study has been completed.
Sponsor:
Information provided by:
Fondazione Poliambulanza Istituto Ospedaliero
ClinicalTrials.gov Identifier:
NCT00713713
First received: July 9, 2008
Last updated: July 31, 2009
Last verified: July 2009

July 9, 2008
July 31, 2009
July 2008
May 2009   (final data collection date for primary outcome measure)
cardiac index [ Time Frame: after 30 minutes of mechanical ventilation with tidal volume of 6 or 12 ml.kg-1 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00713713 on ClinicalTrials.gov Archive Site
  • oxygen delivery [ Time Frame: after 30 minutes of mechanical ventilation with tidal volume of 6 or 12 ml.kg-1 ] [ Designated as safety issue: No ]
  • oxygen consumption [ Time Frame: after 30 minutes of mechanical ventilation with tidal volume of 6 or 12 ml.kg-1 ] [ Designated as safety issue: No ]
  • mixed venous saturation [ Time Frame: after 30 minutes of mechanical ventilation with tidal volume of 6 or 12 ml.kg-1 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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).

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Respiratory Distress Syndrome
Procedure: Mechanical ventilation with low and high tidal volume
Tidal volume of 6 or 12 ml.kg-1, calculated on ideal body weight
Experimental: 1
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.
Intervention: Procedure: Mechanical ventilation with low and high tidal volume
Natalini G, Minelli C, Rosano A, Ferretti P, Militano CR, De Feo C, Bernardini A. Cardiac index and oxygen delivery during low and high tidal volume ventilation strategies in patients with acute respiratory distress syndrome: a crossover randomized clinical trial. Crit Care. 2013 Jul 23;17(4):R146. doi: 10.1186/cc12825.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
June 2009
May 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00713713
FP-TIP-02
No
Natalini Giuseppe, FPoliambulanza
Fondazione Poliambulanza Istituto Ospedaliero
Not Provided
Principal Investigator: Giuseppe Natalini, MD Fondazione Poliambulanza Istituto Ospedaliero
Fondazione Poliambulanza Istituto Ospedaliero
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP