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

Fondazione Poliambulanza Istituto Ospedaliero

Status: Completed

Conditions: Respiratory Distress Syndrome

Treatments: Procedure: Mechanical ventilation with low and high tidal volume

Study type: Interventional

Funder types: Other

Identifiers

NCT00713713

FP-TIP-02

Details and patient eligibility

About

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).

Enrollment: 16 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

16 participants in 1 patient group

1

Experimental group

Description:

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.

Treatment:

Procedure: Mechanical ventilation with low and high tidal volume