1. Comparison of Umbilical Venous and Intraosseous Access During Simulated Neonatal Resuscitation Anand Rajani, M.D. Perinatal Medical Group, Inc. Fresno, California Previous affiliation: Fellow in Neonatal-Perinatal Medicine Stanford University School of Medicine Lucile Packard Children’s Hospital Palo Alto, California

2. Disclosure I have nothing to disclose. This work was supported by the Young Investigator Award from the Neonatal Resuscitation Program.

3. Background While 10% of newborns require some assistance to begin breathing, only 1% require extensive resuscitative efforts Less than 2 in 1000 births require administration of intravenous epinephrine 1 Proficiency in rapid umbilical venous catheter (UVC) placement is difficult to maintain 1. Perlman JM, Risser R. Cardiopulmonary resuscitation in the delivery room. Arch Pediatr Adolesc Med 1995;149:20 – 5

4. Background Establishing umbilical venous access is frequently difficult Catheter setup Thoracic compressions Moving sterile field Data indicate that intraosseous needle (IO) placement is a safe and effective alternative Access times of 30-60 seconds in the pediatric setting 2 Pharmacokinetic data on IO epinephrine in newborn lambs suggest equal efficacy 3 2. Zaritsky AL, Nadkarni UM, Hickey RW, et al. PALS provider manual. Dallas (TX)7 American Heart Association/American Academy of Pediatrics; 2002 3. Ellemunter H, Simma B, Trawoger R, et al. Intraosseous lines in preterm and full term neonates. Arch Dis Child Fetal Neonatal Ed 1990;80:F74-5.

5. Simulation Allows for the re-creation of high-risk, low frequency events in numbers that are useful for statistical analysis Can be video-recorded for further analysis No harm to real patients

6. Hypotheses Primary Null Hypothesis: H o : IO and UVC placement will be established in equal time Secondary Null Hypothesis: H o : IO and UVC placement will be established with equal rates of error Observational Null Hypothesis: H o : Perceived ease of use will be equal for UVC and IO

7. Methods Recruited 40 healthcare practitioners of varying training levels from Lucile Packard Children’s Hospital at Stanford Training LevelN (%) Resident in Pediatrics16 (40) Fellow in Neonatology6 (15) Neonatal Hospitalist5 (12) Neonatal Nurse Practitioner5 (12) Attending Neonatologist8 (20)

8. Methods Two standardized, videotaped simulated resuscitation scenarios in which intravascular access was indicated A nurse and RT confederate performed CPR while the participant established access Indistinguishable kits containing UVCs or IOs were available at the bedside Simulation was stopped once access established

9. Methods: Study Design Prospective, blinded, randomized, 2x2 crossover design Randomized participants in separate blocks, by training level to perform either: UVC/IO or IO/UVC Prior to the simulations, participants watched a video reviewing the necessary steps involved in placement of a UVC and IO needle

10. Methods: Data Collection Using video recordings: Placement Time Errors during placement 4 error categories were used for each modality: 1.Site preparation 2.Device Preparation 3.Location and depth 4.Confirmation of access

11. Methods: Data Collection Using questionnaire: Users perception of technical difficulty (Likert scale from 0-10) Preference for IO or UVC, if any asked for reasons behind preference space left for additional comments

12. Analyses for Primary Hypothesis H o : IO and UVC will be established in equal time Test 1: t-test to evaluate for ‘period effect’ Evaluate the difference in the two time periods of UVC/IO and IO/UVC There was no significant difference in placement times for UVC or IO relative to placement order

13. Analyses for Primary Hypothesis Test 2: Matched pairs t-test to evaluate for any difference in placement time between UVC and IO For placement time, IO was significantly faster (p<0.0001) Using ANOVAs, resident group was significantly faster than all other groups

14. UVC and IO placement by subgroup Training Level (N) UVC Time (sec) IO Time (sec)p value All subjects (40) 10559<0.0001 Residents (16)10517<0.0001 Fellows (6)86730.4431 Hospitalists (5) 104860.4195 NNPs (5)120920.1238 Attendings (8)11194<0.0326

15. Analyses for Secondary Hypotheses H o : IO and UVC will be established with equal rates of error No significant difference was found 3 errors in the IO group (site prep) 1 error in the UVC group (site prep)

16. Analysis of Observational Hypothesis H o : Perceived ease of use will be similar for UVC and IO UVC and IO found to be equivalent Residents (n=16) found IO to be easier to place than UVC (p=0.003) 25% (4) residents preferred IO; 2 had no preference 22 participants preferred the UVC -- all cited familiarity as a reason for this preference difference in experience: years vs. minutes!

17. UVC and IO perceived ease of use by subgroup Training Level (N)UVC difficultyIO difficultyp value All subjects (40) 4.64.30.6762 Residents (16)6.54.750.0026 Fellows (6)4.33.80.6462 Hospitalists (5) 4.460.2420 NNPs (5)2.24.60.1856 Attendings (8)1.82.50.1395

18. Discussion Difference between mean IO and UVC placement was 0.76 minutes (~46 seconds) Identifies differences in time to placement -- does not account for how components are packaged Implications for NRP / Possible practice changes perhaps IO should also be taught and recommended as a placement technique (not shown to be inferior) UVCs could be recommended for use in tertiary care centers where there is consistent experience; IOs may be more appropriate elsewhere

19. Conclusions For the primary hypothesis: must reject H o IO is faster than UVC For the secondary hypothesis: must accept H o no difference in rates of error For the observational hypothesis: must accept H o no difference in perceived ease of use

20. References 1. Perlman JM, Risser R. Cardiopulmonary resuscitation in the delivery room. Arch Pediatr Adolesc Med 1995;149:20-5. 2. Zaritsky AL, Nadkarni UM, Hickey RW, et al. PALS provider manual. Dallas (TX)7 American Heart Association/American Academy of Pediatrics; 2002 3. Ellemunter H, Simma B, Trawoger R, et al. Intraosseous lines in preterm and full term neonates. Arch Dis Child Fetal Neonatal Ed 1990;80:F74-5. 4. Sapien R, Stein H, Padbury JF, Thio S, Hodge D. Intraosseous versus intravenous epinephrine infusions in lambs: Pharmacokinetics and pharmacodynamics. Ped Emerg Care 1992;8:179-183.