MAJOR FINDINGS FROM THE CLINICAL-TRIALS OF THE INTRAVASCULAR OXYGENATOR

Major clinically relevant findings have been extracted and summarized from the database developed from the international multicenter clinical trials of the intravascular oxygenator (IVOX) as a means for augmenting the deficient blood gas transfer of patients in advanced acute respiratory failure (ARF). Between February 1990 and May 1993, a total of 164 IVOX devices were utilized in 160 clinical trial patients who were hypoxemic and/or hypercarbic while receiving closed system positive pressure mechanical ventilator support at or exceeding generally accepted minimum safe levels of intensity. The average rates of oxygen and carbon dioxide transfer into and out of circulating venous blood by means of the IVOX device varied from 40-70 ml/min. Evidence of patient benefit during IVOX utilization includes improvement in blood gas partial pressures associated with decreased intensity of mechanical ventilation, improved hemodynamics in patients with mechanical ventilator depressed cardiovascular function, and decreased indices of lung dysfunction. Clinically recognized IVOX-related complications or adverse events were reported in 24.5% of the clinical trials patients. At necropsy examination of 68 clinical trials patients who died during or after IVOX utilization, forensic pathologists reported 4 cases in which IVOX utilization could have been a primary or contributing cause of death. Significant IVOX device mechanical and/or performance malfunction problems were recognized in 29 (17.7%) of the IVOX devices utilized in clinical trials. IVOX clinical trials data collected and analyzed to date indicate IVOX utilization has a favorable risk/benefit ratio in patients in severe, acute, potentially reversible ARF.