Biomarkers of Lung Injury With Low Tidal Volume Ventilation Compared With Airway Pressure Release Ventilation

Stopped early · Not applicable

Conditions studied: Acute Lung Injury, Adult Respiratory Distress Syndrome

In brief

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.

Key facts

Study ID

NCT01038531

Run by

Boston Medical Center

People needed

3

Starts

2010-07-01

Expected to finish

2016-09-01

Last updated by the study team

2016-12-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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).

Where it is running

• Boston Medical Center — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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