title: 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.
authors.affiliation: Department of Medicine, LDS Hospital, Salt Lake City, Utah 84143.
authors.forename: A H
authors.initials: AH
authors.lastname: Morris
authors.forename: C J
authors.initials: CJ
authors.lastname: Wallace
authors.forename: R L
authors.initials: RL
authors.lastname: Menlove
authors.forename: T P
authors.initials: TP
authors.lastname: Clemmer
authors.forename: J F
authors.initials: JF
authors.lastname: Orme
authors.forename: L K
authors.initials: LK
authors.lastname: Weaver
authors.forename: N C
authors.initials: NC
authors.lastname: Dean
authors.forename: F
authors.initials: F
authors.lastname: Thomas
authors.forename: T D
authors.initials: TD
authors.lastname: East
authors.forename: N L
authors.initials: NL
authors.lastname: Pace
authors.forename: M R
authors.initials: MR
authors.lastname: Suchyta
authors.forename: E
authors.initials: E
authors.lastname: Beck
authors.forename: M
authors.initials: M
authors.lastname: Bombino
authors.forename: D F
authors.initials: DF
authors.lastname: Sittig
authors.forename: S
authors.initials: S
authors.lastname: Böhm
authors.forename: B
authors.initials: B
authors.lastname: Hoffmann
authors.forename: H
authors.initials: H
authors.lastname: Becks
authors.forename: S
authors.initials: S
authors.lastname: Butler
authors.forename: J
authors.initials: J
authors.lastname: Pearl
authors.forename: B
authors.initials: B
authors.lastname: Rasmusson
mesh_terms: D000328:Adult; D002245:Carbon Dioxide / Q000097:blood*; D003131:Combined Modality Therapy; D015199:Extracorporeal Membrane Oxygenation / Q000379:methods*; D005260:Female; D017721:Hospital Costs / Q000706:statistics & numerical data; D006801:Humans; D007902:Length of Stay / Q000706:statistics & numerical data; D015993:Life Tables; D008297:Male; D011175:Positive-Pressure Respiration; D012121:Respiration, Artificial / Q000379:methods*; D012128:Respiratory Distress Syndrome / Q000401:mortality / Q000628:therapy*; D016019:Survival Analysis; D015996:Survival Rate; D016896:Treatment Outcome
chemical_list: D002245:Carbon Dioxide