Acute Respiratory Distress Syndrome Clinical Trial
Official title:
Extracorporeal Carbon Dioxide Removal for Acute Respiratory Distress Syndrome
To compare conventional therapy using low frequency positive pressure ventilation with extracorporeal CO2 removal for the treatment of adult respiratory distress syndrome (ARDS).
BACKGROUND:
It is estimated that at least 150,000 individuals die each year of adult respiratory distress
syndrome. Treatment remains largely supportive. The National Heart, Lung, and Blood Institute
(NHLBI) conducted the Extracorporeal Support for Respiratory Insufficiency (ECMO,
Extracorporeal Membrane Oxygenation) trial from June 1974 through 1978. In ECMO, 90 patients
were randomized to either extracorporeal membrane oxygenation plus conventional therapy or to
conventional therapy. Survival rates were less than ten percent in both groups. The failure
of the trial to demonstrate the superiority of ECMO over conventional ventilatory support
resulted in the virtual elimination of the use of ECMO in clinical medicine.
In the earlier NHLBI trial, ECMO was implemented with a veno-arterial shunt which
approximated 90 percent of the baseline cardiac output. Ventilation of the lungs was
continued with reduced function of inspiration oxygen. Thus, the lungs were deprived of the
principle source of blood supply while continuously exposed to potentially injurious
ventilatory pressures and gas composition. The present patient trial used a new form of
therapy developed by Dr. Gattinoni and co-workers in Milan, Italy with the collaboration of
Dr. Kolobow at the National Institutes of Health in Bethesda. The authors reported a 77
percent survival rate for the new therapy. In Step 1 of the new therapy, the patient was
initially ventilated with pressure-controlled, inverted ratio ventilation. If the patient did
not improve, Step 2 using extracorporeal perfusion was performed with a veno-venous shunt in
contrast to a veno-arterial shunt. The veno-venous shunt preserved pulmonary blood flow
whereas the veno-arterial shunt diminished it. Step 3 was reserved for those patients who did
not meet the therapeutic criteria of Step 2. They underwent low frequency positive-pressure
ventilation and extracorporeal CO2 removal involving veno-venous bypass via the internal
jugular and femoral or bilateral saphenous veins.
DESIGN NARRATIVE:
Randomized, fixed sample. Patients were stratified by age (under and over 40 years) and by
the presence or absence of trauma. Patients were assigned to conventional positive pressure
ventilation therapy or to a three-step therapeutic program employing
pressure-controlled-inverted-ratio-ventilation, continuous positive airway pressure, and
low-frequency positive pressure ventilation-extracorporeal CO2 removal. The main outcome
measure was survival at 30 days after randomization. Secondary outcome measures included
hospital costs, physiologic data, length of hospital stay, and blood product consumption.
Follow-up took place during the year after hospital discharge.
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