Archive for the ‘RCT’ Tag

Non Invasive Ventilation in Acute Cardiogenic Pulmonary Edema

Non-Invasive Ventilation in Acute cardiogenic Pulmonary Edema. Gray, A et al. NEJM, 2008. 359: 142-51. (or here on pubmed)

The “3 interventions in Cardiogenic Pulmonary oedema trial (3CPO)” trail was a multicentre, open, prospective randomised trial. 1069 patients were randomised over 4 years in 23 different centres in the UK. 3 treatment arms, all targeted to achieve sats >92%. 1: Oxygen, 2: CPAP 5-15cmH20 and 3: BiPAP 8-20/4-10.

Previous trials have suggested a reduction in intubation rates and a mortality benefit for CPAP or NIV, but some concerns over an increased MI rate with NIV.

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Multicentre RCTs evaluating mortality in ICU – Doomed to fail?

Multicentre RCTs evaluating mortality in Intensive Care : Doomed to Fail ? Gustavo A. et al. Crit Care Med, 2008, vol 34, no 4.

The authors performed a systematic search for multicentre RCTs in adult ICU targetting mortality as a primary outcome measure. Perhaps surprisingly they found only 72. Of these, 10 reported a positive effect, 7 negative and 55 neutral.

The authors make some interesting points…

  • of the 10 positive results not all have been implemented, either because of tight inclusion criteria or subsequent neutral/ negative evidence
  • 30% of studies failed to adequately report a power calculation
  • assuming a commonly targeted mortality benefit (10%), they estimate approx 60% of studies would be underpowered at the 90% confidence limit.

So is mortality as unrealistic endpoint in disease states inadequately differentiated (like ARDS or sepsis) ?

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