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

Respiratory Distress Syndrome Clinical Trial

— VITALI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00713713
• Other study ID #: FP-TIP-02
• Status: Completed
• Phase: N/A
• First received: July 9, 2008
• Last updated: July 31, 2009
• Start date: July 2008
• Est. completion date: June 2009

Study information

• Verified date: July 2009
• Source: Fondazione Poliambulanza Istituto Ospedaliero
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: June 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor)

Related Conditions & MeSH terms

• Acute Lung Injury
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn

Intervention

Procedure:
• Mechanical ventilation with low and high tidal volume
Tidal volume of 6 or 12 ml.kg-1, calculated on ideal body weight

Locations

Country	Name	City	State
Italy	Intensive Care Unit, Fondazione Poliambulanza Istituto Ospedaliero	Brescia

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Poliambulanza Istituto Ospedaliero

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cardiac index		after 30 minutes of mechanical ventilation with tidal volume of 6 or 12 ml.kg-1	No
Secondary	oxygen delivery		after 30 minutes of mechanical ventilation with tidal volume of 6 or 12 ml.kg-1	No
Secondary	oxygen consumption		after 30 minutes of mechanical ventilation with tidal volume of 6 or 12 ml.kg-1	No
Secondary	mixed venous saturation		after 30 minutes of mechanical ventilation with tidal volume of 6 or 12 ml.kg-1	No
Secondary	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	No
Secondary	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	No