Comparison of Umbilical Venous and Intraosseous Access During Simulated Neonatal Resuscitation Anand...

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 MedicineStanford University School of Medicine

Lucile Packard Children’s HospitalPalo Alto, California

Disclosure• I have nothing to disclose.

• This work was supported by the Young Investigator Award from the Neonatal Resuscitation Program.

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 epinephrine1

• 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

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 setting2

• Pharmacokinetic data on IO epinephrine in newborn lambs suggest equal efficacy3

2. Zaritsky AL, Nadkarni UM, Hickey RW, et al. PALS provider manual. Dallas (TX)7 American Heart Association/American Academy of Pediatrics; 20023. 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.

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

Hypotheses• Primary Null Hypothesis:

• Ho: IO and UVC placement will be established in equal time

• Secondary Null Hypothesis:

• Ho: IO and UVC placement will be established with equal rates of error

• Observational Null Hypothesis:

• Ho: Perceived ease of use will be equal for UVC and IO

Methods• Recruited 40 healthcare practitioners

of varying training levels from Lucile Packard Children’s Hospital at Stanford

Training Level N (%)Resident in Pediatrics 16 (40)

Fellow in Neonatology 6 (15)

Neonatal Hospitalist 5 (12)

Neonatal Nurse Practitioner 5 (12)

Attending Neonatologist 8 (20)

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

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

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

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

Analyses for Primary

Hypothesis• Ho: 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

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

UVC and IO placement by

subgroupTraining Level (N)

UVC Time (sec) IO Time (sec) p value

All subjects (40) 105 59 <0.0001

Residents (16) 105 17 <0.0001

Fellows (6) 86 73 0.4431

Hospitalists (5) 104 86 0.4195

NNPs (5) 120 92 0.1238

Attendings (8) 111 94 <0.0326

Analyses for Secondary Hypotheses

• Ho: 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)

Analysis of Observational

Hypothesis•Ho: 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!

UVC and IO perceived ease of use by subgroupTraining Level (N)

UVC difficulty IO difficulty p value

All subjects (40) 4.6 4.3 0.6762

Residents (16) 6.5 4.75 0.0026

Fellows (6) 4.3 3.8 0.6462

Hospitalists (5) 4.4 6 0.2420

NNPs (5) 2.2 4.6 0.1856

Attendings (8) 1.8 2.5 0.1395

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

Conclusions• For the primary hypothesis: must reject Ho

• IO is faster than UVC

• For the secondary hypothesis: must accept Ho

• no difference in rates of error

• For the observational hypothesis: must accept Ho

• no difference in perceived ease of use

References1.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.