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

NCT ID: NCT00713713

Last Updated: 2009-08-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-07-31
• Study Completion Date: 2009-06-30

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).

Conditions

Respiratory Distress Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Mechanical ventilation with low and high tidal volume

Intervention Type: PROCEDURE

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

Interventions

Mechanical ventilation with low and high tidal volume

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione Poliambulanza Istituto Ospedaliero

OTHER

Sponsor Role: lead

Responsible Party

FPoliambulanza

Principal Investigators

Giuseppe Natalini, MD

Role: PRINCIPAL_INVESTIGATOR

Fondazione Poliambulanza Istituto Ospedaliero

Locations

Intensive Care Unit, Fondazione Poliambulanza Istituto Ospedaliero

Brescia, , Italy

Countries

Italy

References

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.

Reference Type: DERIVED

PMID: 23880084 (View on PubMed)

Other Identifiers

FP-TIP-02

Identifier Type: -

Identifier Source: org_study_id