Airway Pressure Release Ventilation in Acute Lung Injury

Stopped early · Not applicable

Conditions studied: Acute Lung Injury, Acute Respiratory Distress Syndrome, Mechanical Ventilation

In brief

The purpose of this study is to compare airway pressure release ventilation (APRV) to conventional mechanical ventilation (MV) in patients with acute lung injury (ALI) to determine if APRV can reduce agitation, delirium, and requirements for sedative medications. We will also compare markers of inflammation in the blood and lung to determine if APRV reduces ventilator-induced lung injury (VILI), compared to conventional mechanical ventilation. The proposed study is a randomized, crossover trial. We plan to enroll 40 patients with ALI and randomize to APRV or conventional MV for 24 hours. After this time the patients will be switched to the alternative mode of ventilation (MV or APRV) for another 24 hours. To assess breathing comfort, at the end of each 24-hour period we will measure the amounts of sedative and analgesic medications used. We will also measure the concentrations of markers of inflammation in the blood and lung as measures of VILI. Finally, throughout the study we will compare the adequacy of gas exchange with APRV compared to conventional MV.

Key facts

Study ID

NCT00750204

Run by

Johns Hopkins University

People needed

2

Starts

2008-07-01

Expected to finish

2008-10-15

Last updated by the study team

2017-05-15

Who can join

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

You may qualify if…

• Acute onset of:
• Arterial Pressure of Oxygen (PaO2) / FiO2 ≤ 300
• Bilateral infiltrates consistent with pulmonary edema on frontal chest radiograph. The infiltrates may be patchy, diffuse, homogeneous, or asymmetric
• Requirement for positive pressure ventilation via endotracheal tube, and
• No clinical evidence of left atrial hypertension.
• Receiving conventional MV, or lung-protective ventilation (LPV), in the assist control (AC) mode with positive end-expiratory pressure (PEEP) > 5 cm H2O Criteria 1-3 must occur within a 24-hour period. "Acute onset" is defined as follows: the duration of the hypoxemia criterion (#1) and the chest radiograph criterion (#2) must be < 7 days at the time of randomization.

You may not qualify if…

• FiO2 > 70% or PaO2/FiO2 < 125 or arterial pH < 7.25
• Greater than 6 days since all inclusion criteria are met
• Anticipated to begin weaning from MV within 48 hours
• Neuromuscular disease that prevents the ability to generate spontaneous tidal volumes.
• Glasgow Coma Scale (GCS) < 15 within 1 week of intubation
• Acute stroke (vascular occlusion or hemorrhage)
• Current alcoholism or previous daily use of opioids or benzodiazepines before hospitalization
• Acute meningitis or encephalitis
• Pregnancy (negative pregnancy test required for women of child-bearing potential) or breast-feeding.
• Severe chronic respiratory disease
• Previous barotraumas during the current hospitalization
• Clinical evidence of bronchoconstriction on bedside examination (i.e., wheezing).
• Patient, surrogate, or physician not committed to full support
• Severe chronic liver disease (Child-Pugh Score B or C)
• International Normalized Ratio (INR) > 2.0
• Platelet level < 50,000
• Mean arterial pressure < 65, or patient receiving intravenous vasopressors (any dose of epinephrine, norepinephrine, phenylephrine, or dopamine > 5 mcg/kg/min)
• Age < 16 years old
• Morbid obesity (greater than 1kg/cm body weight).
• No consent/inability to obtain consent
• Unwillingness of the clinical team to use conventional low tidal-volume protocol for MV.
• Moribund patient not expected to survive 24 hours.

Where it is running

• Johns Hopkins Hospital Medical Intensive Care Unit — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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