Clinical trial NCT00713713: Effect of Different Ventilatory Strategies on Cardiac Function in Patients With Acute Respiratory Failure
Official title: Hemodynamic Impact of Low and High Tidal Volume Mechanical Ventilation in Acute Lung Injury (ALI)/Acute Respiratory Distress Syndrome (ARDS) Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Distress Syndrome
Keywords: Respiratory Distress Syndrome, Adult
Tidal volume
cardiac output
Respiration, Artificial
Protective ventilation
Lead sponsor: Fondazione Poliambulanza Istituto Ospedaliero
Sponsor class: OTHER
First posted: 2008-07-11
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER

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).


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

Primary outcomes:
measure: cardiac index
timeFrame: after 30 minutes of mechanical ventilation with tidal volume of 6 or 12 ml.kg-1
Secondary outcomes:
measure: oxygen delivery
timeFrame: after 30 minutes of mechanical ventilation with tidal volume of 6 or 12 ml.kg-1
measure: oxygen consumption
timeFrame: after 30 minutes of mechanical ventilation with tidal volume of 6 or 12 ml.kg-1
measure: mixed venous saturation
timeFrame: after 30 minutes of mechanical ventilation with tidal volume of 6 or 12 ml.kg-1
measure: relationship between partitioned elastance (lung and chest wall) and cardiac index difference between ventilation with tidal volume 6 and 12 ml.kg-1
timeFrame: after 30 minutes of mechanical ventilation with tidal volume of 6 or 12 ml.kg-1
measure: abdominal perfusion pressure (mean arterial pressure minus abdominal pressure)
timeFrame: after 30 minutes of mechanical ventilation with tidal volume of 6 or 12 ml.kg-1
Other outcomes:
Locations:
city: Brescia
country: Italy
facility: Intensive Care Unit, Fondazione Poliambulanza Istituto Ospedaliero
Study officials:
affiliation: Fondazione Poliambulanza Istituto Ospedaliero
name: Giuseppe Natalini, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.