Randomized clinical trial of pressure-controlled inverse ratio ventilation and extracorporeal CO2 removal for adult respiratory distress syndrome.

Abstract

The impact of a new therapy that includes pressure-controlled inverse ratio ventilation followed by extracorporeal CO2 removal on the survival of patients with severe ARDS was evaluated in a randomized controlled clinical trial. Computerized protocols generated around-the-clock instructions for management of arterial oxygenation to assure equivalent intensity of care for patients randomized to the new therapy limb and those randomized to the control, mechanical ventilation limb. We randomized 40 patients with severe ARDS who met the ECMO entry criteria. The main outcome measure was survival at 30 days after randomization. Survival was not significantly different in the 19 mechanical ventilation (42%) and 21 new therapy (extracorporeal) (33%) patients (p = 0.8). All deaths occurred within 30 days of randomization. Overall patient survival was 38% (15 of 40) and was about four times that expected from historical data (p = 0.0002). Extracorporeal treatment group survival was not significantly different from other published survival rates after extracorporeal CO2 removal. Mechanical ventilation patient group survival was significantly higher than the 12% derived from published data (p = 0.0001). Protocols controlled care 86% of the time. Average PaO2 was 59 mm Hg in both treatment groups. Intensity of care required to maintain arterial oxygenation was similar in both groups (2.6 and 2.6 PEEP changes/day; 4.3 and 5.0 FIO2 changes/day). We conclude that there was no significant difference in survival between the mechanical ventilation and the extracorporeal CO2 removal groups. We do not recommend extracorporeal support as a therapy for ARDS. Extracorporeal support for ARDS should be restricted to controlled clinical trials.

Review of Extracorporeal Membrane Oxygenation and Dialysis-Based Liver Support Devices for the Use of Nephrologists

“…The mortality rates were high in both groups (90%) likely secondary to the primitive technology and different practices in the ICU at that time. A second trial in 1993 failed to show survival benefits with ECCO 2 R [21]. The only randomized trial in the modern era is the CESAR trial [9], where 90 adult patients with ARDS received conventional ventilation in their local study center and another 90 were transferred to a tertiary care center with ECMO capabilities.…”

Extracorporeal Carbon Dioxide Removal: The Future of Lung Support Lies in the History

“…Extension of this experience to a total of 43 patients demonstrated a reduction in mortality to approximately 50% [24]. However, the negative results of the NIH ECMO trial [25] and of another led by Morris et al [26] dampened the enthusiasm for this strategy, magnified by the concern about the high incidence of major hemorrhagic complications associated with ECMO. Albeit this experience of concern in the past, relentless and concerted efforts of physicians, engineers and industry strived to evolve and refine the technology, placing ECCO2R as an appealing and potentially effective lung assist strategy in the current era.…”

Therapie des akuten Lungenversagens in einem Behandlungszentrum

“…Unsere Aufnahmekriterien waren damit weiter gefasst als in den meisten vergleichbaren Studien [4,27,43].…”