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OpenTrials
Completed

NCT Number: NCT00713713

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

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Intensive Care Unit, Fondazione Poliambulanza Istituto Ospedaliero

Brescia, 25124, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mechanical ventilation with low and high tidal volume

Procedure

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

Primary outcomes

  1. cardiac index

    Time frame: after 30 minutes of mechanical ventilation with tidal volume of 6 or 12 ml.kg-1

Secondary outcomes

  1. oxygen delivery

    Time frame: after 30 minutes of mechanical ventilation with tidal volume of 6 or 12 ml.kg-1

  2. oxygen consumption

    Time frame: after 30 minutes of mechanical ventilation with tidal volume of 6 or 12 ml.kg-1

  3. mixed venous saturation

    Time frame: after 30 minutes of mechanical ventilation with tidal volume of 6 or 12 ml.kg-1

  4. 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

  5. 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

Sponsors and collaborators

Lead sponsor

Fondazione Poliambulanza Istituto Ospedaliero

Other

Registry information

Official study title

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

Acronym: VITALI

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jul 11, 2008
Registry last updated
Aug 3, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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