CESAR TRIAL - ECMO

CESAR TRIAL

Conventional ventilatory support versus ECMO for Severe Adult Respiratory failure (CESAR)

Multicentre randomised controlled trial

Patients were on pulmonary support alone with V V ECMO.

Background – ECMO uses CPB technology to provide gas exchange in severe ,reversible  respiratory failure allowing ventilator settings to be reduced and lungs to recover with such 'lung-rest'.

AIM - To assess whether for patients with severe,reversible, respiratory failure ECMO increases the rate of survival without severe disability by 6 months and be cost effective compared to conventional ventilatory support.

Inclusion criteria -

Adult patients (18–65 years) with severe and potentially reversible respiratoryfailure.

Severe respiratory failure - Murray score  ≥3.0 or uncompensated hypercapnia with a pH <7.20.

Exclusion criteria -

• Duration of high pressure (> 30 cm H₂O PIP) and/or high FIO₂ (> 0.8) ventilation > 7 days.

• Intra-cranial bleeding.

• Contra-indication to limited heparinisation.

• Patients who are moribund and have any contra-indication to continuation of active treatment.

Results -

• 766 patients were screened; 180 were enrolled.
• 90 were randomised to ECMO limb and 90 to conventional medical care limb.
• Primary outcome - survival without severe disability at 6 months post randomisation .
• Secondary outcomes - duration of ventilation, use of HFOV or jet ventilation, use of NO, prone positioning, steroids, duration of ICU stay, duration of hospital stay, method of ECMO, duration of ECMO, blood flow, sweep flow.
• 68 (75%) patients actually received ECMO
• 63% of patients considered for treatment by ECMO survived to 6 months without disability compared with 47% conventional management.
• Referral to consideration for treatment by ECMO treatment led to a gain of 0·03 quality-adjusted life-years (QALYs) at 6-month follow-up.
• A lifetime model predicted the cost per QALY of ECMO to be £19?252 (95% CI) at a discount rate of 3·5%.
• Survival rates of 63% in the ECMO limb and 51% in the conventional limb are improved compared to mortality figures for acute severe respiratory failure in similar studies.
• ECMO was beneficial when survival without severe disability at 6 months was the primary outcome.

Interpretation -  

Adult patients with severe,reversible respiratory failure within the said criteria on optimum conventional management have signi?cantly improved survival without severe disability on ECMO-based management protocol.

References

Giles J Peek, Miranda Mugford, Ravindranath Tiruvoipati, Andrew Wilson, Elizabeth Allen, Mariamma M Thalanany et al.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: 1351–63.

Giles J Peek,Felicity Clemens,Diana Elbourne,Richard Firmin,Pollyanna Hardy,Clare Hibbert et al. CESAR: Conventional ventilatory support vs extracorporeal membrane oxygenation for severe adult respiratory failure. BMC Health Serv Res. 2006; 6: 163.

Clinical opinion - Extracorporeal membrane oxygenation in adults. JP Johnston J R Coll Physicians Edinb 2010; 40:126–7

- by Dr Amarja