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

This study has been completed.
Sponsor:
Information provided by:
Fondazione Poliambulanza Istituto Ospedaliero
ClinicalTrials.gov Identifier:
NCT00713713
First received: July 9, 2008
Last updated: July 31, 2009
Last verified: July 2009
  Purpose

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).


Condition Intervention
Respiratory Distress Syndrome
Procedure: Mechanical ventilation with low and high tidal volume

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Official Title: Hemodynamic Impact of Low and High Tidal Volume Mechanical Ventilation in Acute Lung Injury (ALI)/Acute Respiratory Distress Syndrome (ARDS) Patients

Resource links provided by NLM:


Further study details as provided by Fondazione Poliambulanza Istituto Ospedaliero:

Primary Outcome Measures:
  • cardiac index [ Time Frame: after 30 minutes of mechanical ventilation with tidal volume of 6 or 12 ml.kg-1 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • oxygen delivery [ Time Frame: after 30 minutes of mechanical ventilation with tidal volume of 6 or 12 ml.kg-1 ] [ Designated as safety issue: No ]
  • oxygen consumption [ Time Frame: after 30 minutes of mechanical ventilation with tidal volume of 6 or 12 ml.kg-1 ] [ Designated as safety issue: No ]
  • mixed venous saturation [ Time Frame: after 30 minutes of mechanical ventilation with tidal volume of 6 or 12 ml.kg-1 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 16
Study Start Date: July 2008
Study Completion Date: June 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00713713

Locations
Italy
Intensive Care Unit, Fondazione Poliambulanza Istituto Ospedaliero
Brescia, Italy, 25124
Sponsors and Collaborators
Fondazione Poliambulanza Istituto Ospedaliero
Investigators
Principal Investigator: Giuseppe Natalini, MD Fondazione Poliambulanza Istituto Ospedaliero
  More Information

No publications provided

Responsible Party: Natalini Giuseppe, FPoliambulanza
ClinicalTrials.gov Identifier: NCT00713713     History of Changes
Other Study ID Numbers: FP-TIP-02
Study First Received: July 9, 2008
Last Updated: July 31, 2009
Health Authority: Italy: Ethics Committee

Keywords provided by Fondazione Poliambulanza Istituto Ospedaliero:
Respiratory Distress Syndrome, Adult
Tidal volume
cardiac output
Respiration, Artificial
Protective ventilation

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Respiratory Insufficiency
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury

ClinicalTrials.gov processed this record on July 28, 2014