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

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

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).

Study Overview

• Status: Completed
• Conditions: Respiratory Distress Syndrome
• Intervention / Treatment: Procedure: Mechanical ventilation with low and high tidal volume

• Study Type: Interventional
• Enrollment (Anticipated): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Brescia, Italy, 25124
    • Intensive Care Unit, Fondazione Poliambulanza Istituto Ospedaliero

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: SINGLE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Procedure: Mechanical ventilation with low and high tidal volume; Tidal volume of 6 or 12 ml.kg-1, calculated on ideal body weight

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
cardiac index	after 30 minutes of mechanical ventilation with tidal volume of 6 or 12 ml.kg-1

Secondary Outcome Measures

Outcome Measure	Time Frame
oxygen delivery	after 30 minutes of mechanical ventilation with tidal volume of 6 or 12 ml.kg-1
oxygen consumption	after 30 minutes of mechanical ventilation with tidal volume of 6 or 12 ml.kg-1
mixed venous saturation	after 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-1	after 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

Collaborators and Investigators

• Sponsor: Fondazione Poliambulanza Istituto Ospedaliero

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2008
• Primary Completion (ACTUAL): May 1, 2009
• Study Completion (ACTUAL): June 1, 2009

Study Registration Dates

• First Submitted: July 9, 2008
• First Submitted That Met QC Criteria: July 10, 2008
• First Posted (ESTIMATE): July 11, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): August 3, 2009
• Last Update Submitted That Met QC Criteria: July 31, 2009
• Last Verified: July 1, 2009

More Information

Terms related to this study

• Keywords: Tidal volume; cardiac output; Respiration, Artificial; Respiratory Distress Syndrome, Adult; Protective ventilation
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Disease; Infant, Newborn, Diseases; Infant, Premature, Diseases; Syndrome; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn
• Other Study ID Numbers: FP-TIP-02