ECMO & ARDS. Is the trip down the M1 worthwhile?

Peek GJ, Mugford M, Tiruvoipati R, Wilson A, Allen E, Thalanany MM, Hibbert CL, Truesdale A, Clemens F, Cooper N, Firmin RK, Elbourne D: Efficacy and economic assessment of conventional ventilatory support versus extracorporeal membrane oxygenation for severe adult respiratory failure (CESAR): a multicentre randomised controlled trial. Lancet 2009; 374:1351-1363.

RHH Journal Club. December 15th, 2011. Dr Tom Miller

Full-text article (if available)

For patients with severe, but potentially reversible respiratory failure, compared with conventional ventilation, would an ECMO based protocol increase survival without severe disability (at 6 months) and be cost effective from the perspective of the NHS and society?

Study design:

– Therapeutic & economic assessment                      – Multicentre/Glenfield hospital, Leicester

– 1st Randomised controlled trial (previously only observational studies/case series)

Methodology:

Population

– Patients enrolled between July 2001 and August 2006 from 68 centres

– 180 UK adults, aged 18-65 years, with severe potentially reversible respiratory failure

– Murray score ≥ 3 or pH < 7.2 despite optimum conventional treatment

– Excluded if: Pinsp>30 cmH2O or FiO2>0.8 for more than 7 days, or if heparin contraindicated

Intervention

– Transferred to Glenfield hospital, if haemodynamically stable, standardised ARDS protocol

– If patient did not respond to protocol within 12 hours, then ECMO and lung rest ventilation

Control

– No specific management protocol, but advised lung protective strategy VT = 4-8ml/kg and plateau pressure < 30 cmH2O

Outcomes

Primary – Death at 6 months (or before discharge from hospital) or severe disability after 6 months

Economic – Cost analysis based on care received, estimated cost, QALYs and lifetime incremental costs

Validity:

– Independent central1:1 randomisation service allocated by minimization

– Minimisation; by centre type, age, hours of high pressure/FiO2 ventilation, hypoxia/hypercarbia, diagnostic group and number of organs failed, ensure prognostic factors were similar

– Blinding to treatment clearly not possible, however potentially significant differences in quality of treatment received between the 2 groups. ECMO group treated in a specialized tertiary centre with a standardised ARDS protocol, access to MARS and greater steroid use vs. 30% of conventional group who did not even receive lung protective ventilation strategy at any time

– 6 month follow-up researchers blinded to treatment, but less completed in conventional treatment group

Results:

– 63% of patients survived without severe disability in ECMO group vs. 47% in conventional group (49%)

– Independent of group, if a patient survived to 6 months, they were very unlikely to be severely disabled

– Patients allocated to ECMO group spent twice as long in critical care and hospital as conventional group, thus mean calculated healthcare costs were more than twice as high

– Consideration for ECMO has >50% probability of being cost effective at any expenditure > £20,000/QALY

Conclusions/In Practice:

– Treatment of severe respiratory failure in a specialized tertiary centre with ECMO facilities shows significant improvement in survival

– Although the development of facilities and cost of care is significant, it appears cost effective

– Referral criteria/Murray score calculator at www.cesar-trial.org, referrals to local centre (now 7 centres)

– NICE guidance April 2011 / Extracorporeal Life Support Organisation (ELSO)

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One thought on “ECMO & ARDS. Is the trip down the M1 worthwhile?

  1. Pingback: STH Breakfast Club: ARDS | STH Journal Club

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