Best Evidence Topics

Cohort

Rebecca K. Fastle and Mark G. Roback.
Pediatric rapid sequence intubation: Incidence of reflex bradycardia and effects of pretreatment with atropine.
Pediatric Emergency Care
October 2004. Vol 20; pg 651-55.
  • Submitted by:Alan Bean - Emergency Medicine Resident
  • Institution:Butterworth Hospital
  • Date submitted:13th February 2005
Before CA, i rated this paper: 9/10
1 Objectives and hypotheses
1.1 Are the objectives of the study clearly stated?
  Yes
2 Design
2.1 Is the study design suitable for the objectives?
  No, this is a retrospective study and would best be studied in a prospective, randomized fashion.
2.2 Who / what was studied?
  Pediatric patients up to 19 years of age who received endotracheal intubation in a level 1 pediatric trauma center from 1997-2001.
2.3 Was a control group used if appropriate?
  No, patients meeting the inclusion criteria were placed into cohorts defined by whether or not they had received atropine prior to intubation.
2.4 Were outcomes defined at the start of the study?
  Yes, it was defined as a heart rate two standard deviations below the mean for age (defined by the American Heart Association) or a greater than 30% change in baseline heart rate during intubation.
2.5 Was this the right sample to answer the objectives?
  Yes
2.6 Is the study large enough to achieve its objectives? Have sample size estimates been performed?
  No, it would require at least 1238 patients in both the control and the treatment group to achieve an alpha of .05. This is based on the fact that bradycardic events only occurred in only 4% of the total study population.
2.7 Were all subjects accounted for?
  Yes, 10 charts were incomplete for various reasons and not included in the final analysis.
2.8 Were all appropriate outcomes considered?
  Yes, it included hypoxia, bradycardia and comparison of these events
with the paralytic agent of choice.
2.9 Has ethical approval been obtained if appropriate?
  N/A, retrospective chart review
3 Measurement and observation
3.1 Is it clear what was measured, how it was measured and what the outcomes were?
  Yes, the paper makes this very clear and is consistent with these measurements.
3.2 Was the assessment of outcomes blinded?
  No
3.3 Was follow up sufficiently long and complete?
  Yes, this study was looking for acute changes not long term outcomes.
3.4 Are the measurements valid?
  Yes
3.5 Are the measurements reliable?
  Yes
3.6 Are the measurements reproducible?
  Yes
4 Presentation of results
4.1 Are the basic data adequately described?
  Yes. In addition, the table are very useful adjuncts.
4.2 Are the results presented clearly, objectively and in sufficient detail to enable readers to make their own judgement?
  Yes
4.3 How large are the effects within a specified time?
  A heart rate that falls two standard deviations or more below the mean for age (defined by the American Heart Association) or a greater than 30% change in baseline heart rate. The measurements were taken immediately before and after any intervention (including endotracheal intubation) and after any change in patient status.
4.4 Are the results internally consistent, i.e. do the numbers add up properly?
  Yes
5 Analysis
5.1 Are the data suitable for analysis?
  Yes
5.2 Are the methods appropriate to the data?
  Yes
5.3 Are any statistics correctly performed and interpreted?
  Yes
6 Discussion
6.1 Are the results discussed in relation to existing knowledge on the subject and study objectives?
  Yes
6.2 Is the discussion biased?
  No
7 Interpretation
7.1 Are the author's conclusions justified by the data?
  The conclusions are somewhat premature based on the fact their sample sizes were too small to achieve adequate power.
7.2 What level of evidence has this paper presented? (using CEBM levels)
  2a
7.3 Does this paper help me to answer my problem?
  No, but this data suggests that the mandatory use of atropine may not be required for all pediatric patients and certainly further research is warranted.
After CA, i rated this paper: 7/10
8 Implementation
8.1 Can any necessary change be implemented in practice?
  No, there is currently no absolute standard being followed locally. This study will unlikely change practice either for or against using atropine in pediatric rapid sequence intubations. However, a more definitive study likely would do this.
8.2 What aids to implementation exist?
  N/A, physicians already have access to atropine for use in the studied situations.
8.3 What barriers to implementation exist?
  The lack of power and a randomized controlled trial.
8.4 Are the study patients similar to your own?
  Yes
8.5 Does the paper give any conclusions that will affect what you will offer or tell your patient?
  Yes, this data demonstrates that some pediatric patients will experience bradycardia associated with intubation regardless of atropine pre-treatment.