CESAR

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Peek GJ, 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.". The Lancet. 2009. 374(9698):1351-1363.
PubMedFull text

Clinical Question

Does ECMO increase 6 month survivability without severe disability in patients with severe but reversible respiratory failure comparted to convetional ventilator management? Is ECMO cost-effective compared to conventional ventilator support?

Bottom Line

ECMO is cost effective and does increase survival without severe disability at 6 months in patients with severe reversible respiratory failure compared to conventional management in the UK.

Major Points

The previous trials regarding ECMO use were perfomred with outdated protocols. The CESAR trial was designed with current ECMO protocols to determine the benefit of ECMO in terms of survival without disability at 6 months compared to conventional therapy in patients with severe respiratory failure. They have shown that referall for ECMO is associated with increased survival without severe disability at 6 months and is economically reasonable in the United Kingdrom.

Guidelines

Design

  • Randomized control trial
  • N=180
    • ECMO (n=90)
    • Conventional Manamgement (n=90)
  • Setting: 92 Conventional Treatment Centers, 11 Referal Hospitals and 1 ECMO center in the UK. If included in the trial participants were transferred to either a convetional treatment center or to the ECMO center.
  • Enrollment: July 2001 to August 2006
  • Mean follow-up: 6 months
  • Analysis: Intention-to-treat
  • Primary outcome: Death or severe disability at 6 months

Population

Inclusion Criteria

  • Adults 18-65
  • Severe respiratory failure with Murray Score >/=3.0 or uncompensated hypercapnea with pH<7.20

Exclusion Criteria

  • >7 days of prior high pressure (>30cm H2O) or high FiO2 (>0.80) ventilation
  • Contraindiaction to heparin including intra-cranial bleed
  • Moribund patients as determined by ECMO consultant
  • Any other contra-indication to continued treatment

Baseline Characteristics

  • Mean age: 40
  • Percent male: 58
  • Primary diagnosis: Pneumonia 61%, other ARDS 29%
  • Mean hours of positive pressure ventilation at entry: 36
  • Mean hours of high-pressure ventilation or high FiO2 at entry: 28
  • APACHE II score: 19
  • Mean Murray score: 3.5

Interventions

  • 180 eligible patients were randomized into ECMO(n=90) or conventional ventilator management(n=90)
  • If assigned to ECMO or convetional managment and at a referall hospital or conventional managment center, patients were transported to either a conventional managment center or to the ECMO center
  • The 90 patients assigned to conventional management all received conventional management
  • 22 patients randomized to ECMO did not recieve ECMO because they improved with conventional management (n=16, died prior to transfer (n=3) or during transfer (n=2), or had a contra-indication to heparin (n=1)
  • ECMO protocol was veno-venous via cannulation of the femoral or right jugular veins. Normothermia was maintained, venitaltor setings were reduced gradually to allow lung rest, anticoagulation was mainteded with heparin, patients were fed parenterally or enterally, hemofiltration was provided as needed, Hgb concentration was maintained at 14g/dl and platelets at >100,000, and if liver failure developed patients were supported with the Molecular Absorbent Recirculating System. ECMO was weaned when chest Xray showed improvement, lung compliance improved and patient was ventilating well while ECMO was turned off.
  • Conventional management included all conventional management means at the discretion of the treating intensivists. They were recommended to use a low ventilation strategy (TV 4-8 ml/kg).
  • At six months all participants were screened with SF-36, EQ-5D, St Georges hospital respiratory questionnaire, hospital anxiety and depsression scale and the mini-mental status examination tools. Spirometry was also used to assess pulmonary function.

Outcomes

Comparisons are assignment to ECMO vs conventional management.

Primary Outcomes

Survival without severe disability (not being able to wash or dress alone) at 6 months
63% vs. 47% (RR 0.69; 95% CI 0.5-0.97; P=0.03)

Secondary Outcomes

Duration of stay in intensive care
24 days vs. 13 days
Duration of stay in the hospital
35 days vs. 17 days

Adverse Events

  • One patient died during transfer to ECMO center secondary to mechanical failure of the ambulance oxygen supply.
  • One patient had a vessel perforated during ECMO cannulation and this was consider contributory to his ultimate demise.

Criticisms

Funding

UK NHS Health Technology Assessment, English National Specialist Commissioning Advisory Group, Scottish Departmenbt of Health, and the Welsh Department of Health

Further Reading