Clinical trial NCT00793013: Airway Pressure Release Ventilation (APRV) Compared to ARDSnet Ventilation
Official title: Primary Resuscitation Using Airway Pressure Release Ventilation Improves Recovery From Acute Lung Injury or Adult Respiratory Distress Syndrome and Reduces All Cause Mortality Compared to ARDS Net Low Tidal Volume-Cycled Ventilation.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Acute Lung Injury
Adult Respiratory Distress Syndrome
Kidney Injury
Keywords: Acute Lung Injury
Adult Respiratory Distress Syndrome
Airway Pressure Release Ventilation
Acute Kidney Injury
Pressure Trial
Lead sponsor: University of Tennessee, Chattanooga
Sponsor class: OTHER
First posted: 2008-11-18
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Traditional modes of ventilation have failed to improve patient survival. Subsequent observations that elevated airway pressures observed in traditional forms of ventilation resulted in barotrauma and extension of ALI lead to the evolution of low volume cycled ventilation as a potentially better ventilatory modality for ARDS. Recent multicenter trials by the NIH-ARDS network have confirmed that low volume ventilation increases the number of ventilatory free days and improves overall patient survival. While reducing mean airway pressure has reduced barotrauma and improved patient survival, it has impaired attempts to improve alveolar recruitment. Alveolar recruitment is important as it improves V/Q mismatch, allows reduction in FIO2 earlier, and decreases the risk of oxygen toxicity. Airway pressure release ventilation (APRV) is a novel ventilatory modality that utilizes controlled positive airway pressure to maximize alveolar recruitment while minimizing barotrauma. In APRV, tidal ventilation occurs between the increase in lung volumes established by the application of CPAP and the relaxation of lung tissue following pressure release. Preliminary studies have suggested that APRV recruits collapsed alveoli and improves oxygenation through a restoration of pulmonary mechanics, but there are no studies indicating the potential overall benefit of APRV in recovery form ALI/ADRS.

Detailed description: Low volume ventilation may increase number of ventilatory free days and may improve overall patient survival. While reducing mean airway pressure has reduced barotrauma and improved patient survival, it has impaired attempts to improve alveolar recruitment. Alveolar recruitment is important as it improves V/Q mismatch, allows reduction in FIO2 earlier, and decreases the risk of oxygen toxicity. Airway pressure release ventilation (APRV) is a novel ventilatory modality that utilizes controlled positive airway pressure to maximize alveolar recruitment while minimizing barotrauma. In APRV, tidal ventilation occurs between the increase in lung volumes established by the application of CPAP and the relaxation of lung tissue following pressure release. Preliminary studies have suggested that APRV recruits collapsed alveoli and improves oxygenation through a restoration of pulmonary mechanics, but there are no studies indicating the potential overall benefit of APRV in recovery form ALI/ADRS.

Eligibility criteria: Inclusion Criteria:

* All patients admitted to the Internal Medicine service at the Baroness Erlanger Hospital of the University of Tennessee College of Medicine with hypoxia (O2 saturation \< 93%) and pulmonary distress, will be screened for study participation.
* Patients displaying all the following clinical criteria: acute onset of respiratory failure; hypoxia defined as a PaO2/FiO2 ratio of \< 300 Torr; pulmonary capillary wedge pressure less or equal than 18 mm Hg, and/or no clinical evidence of left sided heart failure; and chest x-ray with diffuse bilateral pulmonary infiltrates.

Exclusion Criteria:

* Patients receiving conventional volume ventilation with or without PEEP for \> 6 hours prior to study enrollment
* Patient's family or surrogate unwilling to give informed consent
* Patients requiring sedation or paralysis for effective ventilation
* Patients known pulmonary embolus within 72 hours of study enrollment
* Patients with close head injuries or evidence of increased intracranial pressure
* Patients with burns over 30% of total body surface area
* Pulmonary capillary wedge pressure greater than 18 mm Hg
* CVP \> 15 cm H2O
* Patients with B type Naturetic peptide levels \> 1000
* Patients with prior history of dilated cardiomyopathy with EF \< 25%
* Patients receiving chronic outpatient peritoneal or hemodialysis
* Patients with severe liver disease (as defined by Child-Pugh class C)
* AIDS patients

Primary outcomes:
measure: All cause mortality
timeFrame: 28 days or prior to hospital discharge
Secondary outcomes:
measure: Number of ventilator-free days
timeFrame: 28 days or prior to hospital discarge
measure: Length of ICU stay and /or Total hospital days
timeFrame: 28 days or prior to hospital discharge
measure: To determine the effects of APRV ventilation versus ARDS net low volume-cycle ventilation on the incidence of of AKI
timeFrame: 28 days or prior to hospital discharge
measure: To determine the effects of APRV ventilation versus ARDS net low volume-cycle ventilation on the NGAL, KIM-1, and IL-18 urine biomarkers for AKI
timeFrame: 28 days or prior to hospital discharge
measure: To determine the effects of APRV ventilation versus ARDS net low volume-cycle ventilation in maintaining hourly urine output > 0.5 mls/kg/hr
timeFrame: 28 days or prior to hospital discharge
measure: Will determine urinary aquaporin-2 levels in patients randomized to APRV ventilation versus ARDS net low volume-cycle ventilation
timeFrame: 28 days or prior to hospital discharge
Other outcomes:
Locations:
city: Chattanooga
country: United States
facility: James A. Tumlin, MD
state: Tennessee
Study officials:
affiliation: University of Tennessee
name: James A Tumlin, MD
role: PRINCIPAL_INVESTIGATOR
References: