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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mechanical ventilation with low and high tidal volume | Procedure | Tidal volume of 6 or 12 ml.kg-1, calculated on ideal body weight |
|
| Measure | Description | Time Frame |
|---|---|---|
| cardiac index | after 30 minutes of mechanical ventilation with tidal volume of 6 or 12 ml.kg-1 |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Giuseppe Natalini, MD | Fondazione Poliambulanza Istituto Ospedaliero | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Intensive Care Unit, Fondazione Poliambulanza Istituto Ospedaliero | Brescia | 25124 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23880084 | Derived | 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. |
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| ID | Term |
|---|---|
| D012128 | Respiratory Distress Syndrome |
| D053120 | Respiratory Aspiration |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D012121 | Respiration, Artificial |
| ID | Term |
|---|---|
| D058109 | Airway Management |
| D013812 | Therapeutics |
| D012151 | Resuscitation |
| D004638 | Emergency Treatment |
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| 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 |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D012138 |
| Respiratory Therapy |