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RCT: ENDOTRACHEAL SURFACTANT FOR ARDS PATIENTS?

Citation/s:Effect of Recombinant Surfactant Protein C- based Surfactant on the Acute Respiratory Distress Syndrome. New Engl J Med 2004; 351: 884-92

Lead author's name and fax: Roger G.Spragg: rspragg@ucsd.edu

Three-part Clinical Question: In patients with Acute Respiratory Distress Syndrome does a 24 hour course of Recombinant Surfactant Protein C- based Surfactant decrease requirement for mechanical ventilation and improve survival?

Search Terms: Acute respiratory distress syndrome, Mechanical ventilation, Exogenous surfactant, Intensive care unit, Survival.

Study Selection: Controlled, randomized, double blind, concealed trial with intention-to-treat.

Patient key characteristics: Adults [Age >50 years] in intensive care units with diagnosis of acute respiratory distress syndrome needing endotracheal intubation and mechanical ventilation. The groups were similar at baseline with respect to age, sex, vital signs, arterial blood gas measurements, ventilators variables, SOFA and mean APACHE II scores. Patients were enrolled from different hospitals in North America, Europe and South Africa.

Control group [N=224,all analysed]: Received standard ARDSnet ventilatory strategy ventilation for ARDS.

Experimental group [N=224; 223 analysed]: Received standard ARDSnet ventilatory strategy ventilation plus recombinant surfactant protein C- based surfactant. Patients were administered up to 4 doses of surfactant intratracheally [dose- 1ml/kg] at 4-hour intervals within a period of 24 hours

The Evidence:

Comments:

Patients who received surfactant had a greater improvement in gas exchange during the 24-hour treatment period. This effect was lost after 24 hours of treatment. There was no significant difference between the groups in terms of mortality or the need for mechanical ventilation.

EBM questions:

1) Do the methods allow accurate testing of the hypothesis? Yes
2) Do the statistical tests correctly test the results to allow differentiation of statistically significant results? Yes
3) Are conclusions valid in light of the results? Yes
4) Did results get omitted, and why? Yes. One patient had a serious adverse event during the baseline period and was not treated. (Difficult to tell if this patient was included in the intention-to-treat analysis.)
5) Did they suggest areas of further research? Yes. The observations indicate the probable need for a prolonged treatment period, possibly with greater intervals between doses or with a larger number of doses than those studied so far. [See above table: Significant improvement in PaO₂/F_IO₂during first 24 hours of treatment period not maintained after this time]. The loss of the effect on oxygenation after 24 hours makes the presence of a false negative results (i.e. the presence of a significant treatment effect being present but not demonstrated) less likely.
6) Did they make any recommendations based on the results and were they appropriate? Yes. Routine use of surfactant for 24 hrs is not merited.
7) Is the study relevant to my clinical practice? Yes
8) What level of evidence does this study represent? 1++
9) What grade of recommendation can I make on this result alone? A

10) What grade of recommendation can I make when this study is considered along with other available evidence? A
11) Should I change my practice because of these results? No
12) Should I audit my current practice because of these results? No

Appraised by: Dr.B.K.Basu SHO, Falkirk and District Royal Infirmary, Falkirk July 2005
Email: basubk@yahoo.com
Kill or Update by: June 2010

Edited and quality checked by CC & BH Cuthbertson July 2005

Citation: EBM Critical Appraisals. Scottish Intensive Care Society EBM Group. Bhadrajkumar B. 2005. : Spragg RG, et al.Effect of Recombinant Surfactant Protein C- based Surfactant on the Acute Respiratory Distress Syndrome. New Engl J Med 2004; 351: 884-92

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