Biomarkers of Lung Injury With Low Tidal Volume Ventilation Compared With Airway Pressure Release Ventilation
| Status: | Suspended |
|---|---|
| Conditions: | Hospital, Pulmonary |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | July 2010 |
| End Date: | September 2016 |
Acute lung injury (ALI) and the acute respiratory distress syndrome (ARDS) represent a
spectrum of clinical syndromes of rapid respiratory system deterioration that are associated
with both pulmonary and systemic illness. These syndromes are associated with 30-40%
mortality with our current standard of care and are responsible for approximately 75,000
deaths in the US yearly. Current evidence-based care of ALI consists of a strategy of
mechanical ventilation utilizing low lung volumes (ARDSNet ventilation) intended to limit
further stretch-induced lung injury exacerbated by the ventilator. However, this strategy
has been shown to be associated with increased lung injury in a subset of patients and still
is associated with about a 30% mortality rate. Airway pressure release ventilation (APRV) is
a different, non-experimental strategy of mechanical ventilation currently in routine
clinical use. APRV is a pressure-cycled ventilator mode that allows a patient a greater
degree of autonomy in controlling his or her breathing pattern than ARDSNet ventilation. Use
of APRV has been associated with better oxygenation, less sedative usage, and less
ventilator-associated pneumonia in small studies compared with other ventilator modes.
However, debate exists over whether APRV might result in decreased or increased
ventilator-associated lung injury when compared with ARDSNet ventilation. We intend to
implement a randomized, cross over study looking at biomarkers of lung injury in patients
with acute lung injury during ventilation with APRV and using the ARDSNet protocol. Our
hypothesis is that airway pressure release ventilation is associated with lower levels of
lung injury biomarkers than ARDSNet ventilation.
spectrum of clinical syndromes of rapid respiratory system deterioration that are associated
with both pulmonary and systemic illness. These syndromes are associated with 30-40%
mortality with our current standard of care and are responsible for approximately 75,000
deaths in the US yearly. Current evidence-based care of ALI consists of a strategy of
mechanical ventilation utilizing low lung volumes (ARDSNet ventilation) intended to limit
further stretch-induced lung injury exacerbated by the ventilator. However, this strategy
has been shown to be associated with increased lung injury in a subset of patients and still
is associated with about a 30% mortality rate. Airway pressure release ventilation (APRV) is
a different, non-experimental strategy of mechanical ventilation currently in routine
clinical use. APRV is a pressure-cycled ventilator mode that allows a patient a greater
degree of autonomy in controlling his or her breathing pattern than ARDSNet ventilation. Use
of APRV has been associated with better oxygenation, less sedative usage, and less
ventilator-associated pneumonia in small studies compared with other ventilator modes.
However, debate exists over whether APRV might result in decreased or increased
ventilator-associated lung injury when compared with ARDSNet ventilation. We intend to
implement a randomized, cross over study looking at biomarkers of lung injury in patients
with acute lung injury during ventilation with APRV and using the ARDSNet protocol. Our
hypothesis is that airway pressure release ventilation is associated with lower levels of
lung injury biomarkers than ARDSNet ventilation.
Acute lung injury (ALI) and the acute respiratory distress syndrome (ARDS) represent a
spectrum of clinical syndromes of rapid respiratory system deterioration that are associated
with both pulmonary and systemic illness. These syndromes are associated with 30-40%
mortality with our current standard of care and are responsible for approximately 75,000
deaths in the US yearly. The current evidence-based care consists of a strategy of
mechanical ventilation utilizing low lung volumes (ARDSNet ventilation) intended to limit
further lung injury from overstretch of the lung induced by the ventilator. However, this
strategy has been shown to be associated with continued lung injury in some studies and
still is associated with about a 30% mortality rate. Airway pressure release ventilation
(APRV) is a different, nonexperimental strategy of mechanical ventilation currently in
routine clinical use. APRV allows a patient a greater degree of autonomy in controlling
his/her breathing while achieving a higher mean airway pressure (at similar plateau
pressures) than that typically achieved with ARDSNet. APRV has been associated with less
ventilator-associated pneumonia, better oxygenation, and less sedative usage in small
studies when compared with other methods of ventilation. However, debate exists over net
effects of APRV with regard to ventilator-associated lung injury. Additionally, we recently
completed a study showing that APRV was associated with lower ventilator associated
pneumonia (VAP) rates, but this benefit did not appear to be mediated by sedation
differences. We hypothesized that the VAP benefits might be mediated by greater lung
recruitment and possibly less ventilator-induced lung injury with APRV. We propose a
randomized, crossover study looking at biomarkers of lung injury in patients with acute lung
injury ventilated with APRV and ARDSNet. Our hypothesis is that airway pressure release
ventilation is associated with lower levels of lung injury biomarkers than ARDSNet
ventilation.
spectrum of clinical syndromes of rapid respiratory system deterioration that are associated
with both pulmonary and systemic illness. These syndromes are associated with 30-40%
mortality with our current standard of care and are responsible for approximately 75,000
deaths in the US yearly. The current evidence-based care consists of a strategy of
mechanical ventilation utilizing low lung volumes (ARDSNet ventilation) intended to limit
further lung injury from overstretch of the lung induced by the ventilator. However, this
strategy has been shown to be associated with continued lung injury in some studies and
still is associated with about a 30% mortality rate. Airway pressure release ventilation
(APRV) is a different, nonexperimental strategy of mechanical ventilation currently in
routine clinical use. APRV allows a patient a greater degree of autonomy in controlling
his/her breathing while achieving a higher mean airway pressure (at similar plateau
pressures) than that typically achieved with ARDSNet. APRV has been associated with less
ventilator-associated pneumonia, better oxygenation, and less sedative usage in small
studies when compared with other methods of ventilation. However, debate exists over net
effects of APRV with regard to ventilator-associated lung injury. Additionally, we recently
completed a study showing that APRV was associated with lower ventilator associated
pneumonia (VAP) rates, but this benefit did not appear to be mediated by sedation
differences. We hypothesized that the VAP benefits might be mediated by greater lung
recruitment and possibly less ventilator-induced lung injury with APRV. We propose a
randomized, crossover study looking at biomarkers of lung injury in patients with acute lung
injury ventilated with APRV and ARDSNet. Our hypothesis is that airway pressure release
ventilation is associated with lower levels of lung injury biomarkers than ARDSNet
ventilation.
Inclusion Criteria:
- Age > or equal to 18.
- On mechanical ventilation using a volume-controlled mode.
- Admitted to Boston Medical Center Surgical, Medical, or Coronary Intensive Care Unit.
- Meets American-European Consensus Criteria for Acute Lung Injury (ALI) or Acute
Respiratory Distress Syndrome.
- Required mechanical ventilator for less than 14 days.
- Met ARDS or ALI criteria for less than 7 days prior to enrollment.
- Assent of primary care team
Exclusion Criteria:
- Do not resuscitate order.
- Increased intracranial pressure.
- Pregnancy (urine pregnancy test for all women of child-bearing age).
- Planned transport out of ICU during planned study protocol.
- Coagulopathy (INR>2.0 or PTT >50).
- Severe thrombocytopenia (platelets <20,000).
- History of obstructive lung disease (asthma and/or COPD).
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