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RCTs of ECLS in Adults NIH Adult ECMO Trial Zapol et al JAMA 242:2193-96,1979 PCIRV vs ECCO2R Morris et al, Am J Respir Crit Care Med 1994;149:295-305. Early Adult ECMO/ECCO2R Trials Zapol, : (NIH Trial) (VA ECMO +ventilation and ventilation only) Severe ARF. A Randomized Prospective Study. JAMA 1979:242:2193-6) 90 patients, 9 US centres, 1974 - 77 Survival 10% in both arms Criticism: 1. VA ECMO used (prone to microthrombi in lungs) 2. High anticoagulation and bleeding complications 3. High pressure ventilation used even DURING ECMO 4. Mean duration of ventilation prior to ECMO was 9 days Little experience, varying technique in different centres Early Adult ECMO/ECCO2R Trials Morris, et.al: Randomized Trial of PCIRV and ECCO2R in ARDS. AJRCCM,1994;149:295-305 40 patients, severe ARDS (paO2/FiO2 63 mmHg) in one US centre 33% survival in 21 patients ECCO2R + LFPPV 42% survival in 19 patients PCIRV P = 0.8, no significant difference Little previous experience in centre with technique in humans High pressure ventilation before and DURING ECCO2R (PEEP 20, Peak 45 - 55 cmH2) Frequent severe bleeding complications (leading to discontinuation of ECCO2R in 7/19 cases) BOTH TRIALS HAVE LITTLE RELEVANCE TO CURRENT ECMO REGIMENS OBSERVATIONAL STUDIES Cohort studies of ECMO- Leicester 1997. PaO2/FIO2 65mmhgMurray Score=3.4 Cohort Studies of ECLS - Other LFPPV with ECCO2R in severe acute respiratory failure, Gattinoni L et al, JAMA 1986 256;7:881-6 (50% survival) ECLS for 100 adult patients with severe respiratory failure.PaO2/FiO2 = 55mmHg Kolla S et al, Ann Surg 1997;226:544-64 (survival 54%) OUTCOME IN ADULTS WHEN ECMO IS UNAVAILABLE Results Conventional patients 8/28 Survived (28.5%) ECMO patients 39/57 Survived (68.4%) p=0.001 However, time has passed and things have changed since ... Some centres in the US and Europe have been quite successful at providing ECMO for severe adult respiratory failure (Ann Arbor, Michigan, Berlin, Marburg, Munich, Glenf
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