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

NCT00713713 | Completed

• 1 other identifier: FP-TIP-02
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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

Keywords

Respiratory Distress Syndrome, Adult; Tidal volume; cardiac output; Respiration, Artificial; Protective ventilation

Outcome Measures

Primary Outcomes (1)

• cardiac index

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

Secondary Outcomes (5)

• 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

Study Arms (1)

1

EXPERIMENTAL

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

Interventions

Mechanical ventilation with low and high tidal volume PROCEDURE

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

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosis of ARDS/ALI

You may not qualify if:

• mean arterial pressure lower than 65 mmHg
• beginning or change of vasoactive agents infusion rate in the last 2 hours

Sponsors & Collaborators

• Fondazione Poliambulanza Istituto Ospedaliero: lead

Study Sites (1)

Intensive Care Unit, Fondazione Poliambulanza Istituto Ospedaliero

Brescia, 25124, Italy

Location

Related Publications (1)

• 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.

  PMID: 23880084 DERIVED

MeSH Terms

Conditions

Respiratory Distress Syndrome; Respiratory Aspiration

Interventions

Respiration, Artificial

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Airway Management; Therapeutics; Resuscitation; Emergency Treatment; Respiratory Therapy

Study Officials

• Giuseppe Natalini, MD

  Fondazione Poliambulanza Istituto Ospedaliero

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 9, 2008
• First Posted: July 11, 2008
• Study Start: July 1, 2008
• Primary Completion: May 1, 2009
• Study Completion: June 1, 2009
• Last Updated: August 3, 2009

Record last verified: 2009-07

Locations

IT (1)