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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00713713
Acronym
VITALI
Enrollment
16
Registered
2008-07-11
Start date
2008-07-31
Completion date
2009-06-30
Last updated
2009-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Distress Syndrome

Keywords

Respiratory Distress Syndrome, Adult, Tidal volume, cardiac output, Respiration, Artificial, Protective ventilation

Brief 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).

Interventions

PROCEDUREMechanical ventilation with low and high tidal volume

Tidal volume of 6 or 12 ml.kg-1, calculated on ideal body weight

Sponsors

Fondazione Poliambulanza Istituto Ospedaliero
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
cardiac indexafter 30 minutes of mechanical ventilation with tidal volume of 6 or 12 ml.kg-1

Secondary

MeasureTime frame
oxygen deliveryafter 30 minutes of mechanical ventilation with tidal volume of 6 or 12 ml.kg-1
oxygen consumptionafter 30 minutes of mechanical ventilation with tidal volume of 6 or 12 ml.kg-1
mixed venous saturationafter 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-1after 30 minutes of mechanical ventilation with tidal volume of 6 or 12 ml.kg-1
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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026