DAS Small Grant

Children's Health Ireland at Temple Street, Dublin

Title
A prospective bench-top randomized study to compare Cric-Guide, a novel paediatric emergency front of neck access device, with a scalpel technique in a porcine model

Amount
£4,480

Scientific Abstract
The DAS recommend cricothyroidotomy for eFONA for a CICV scenario in children aged one to eight years¹. There are limited data on the optimal approach. A new device has been developed based on our ultrasonic and MRI derived cricothyroid membrane (CTM) measurements² ³. It is a channelled bougie insertion device with a sharpened leading edge. It has not been assessed to date in a paediatric model. We seek to compare this device to scalpel cricothyroidotomy in a laboratory model using excised animal tracheas. The study will be a prospective bench-top randomised study using the methodology described in a recent systematic review of the paediatric emergency surgical airway⁴. The primary outcome is success rate of entry of ETT into the airway determined by dissection post placement. Secondary outcomes include time to tracheal access, complications and perceived ease of use on a visual analogue scale. In anticipation of success rates of a similar adult study performed in our lab we calculate with an effect size of 25% that a minimum sample size of 98 per group would be adequate with 80% power at the 5% significance level and appropriate correction for multiple testing. Additional specimens will be required for training prior to participation.

References:
1. Black AE, Flynn PER, Smith HL, Thomas ML, Wilkinson KA. Development of a guideline for the management of the unanticipated difficult airway in pediatric practice. Paediatric Anaesthesia. 2015;25(4):346-362. doi:10.1111/pan.12615
2. Walsh B, Fennessy P, Ni Mhuircheartaigh R, Snow A, McCarthy KF, McCaul CL. Accuracy of ultrasound in measurement of the pediatric cricothyroid membrane. Paediatric Anaesthesia. 2019;29(7):744-752. doi:10.1111/pan.13658
3. Fennessy P, Walsh B, Laffey JG, McCarthy KF, McCaul CL. Accuracy of pediatric cricothyroid membrane identification by digital palpation and implications for emergency front of neck access. Paediatric Anaesthesia. 2020;30(1):69-77. doi:10.1111/pan.13773
4. Koers L, Janjatovic D, Stevens MF, Preckel B. The emergency paediatric surgical airway: A systematic review. European Journal of Anaesthesiology. 2018;35(8):558-565. doi:10.1097/EJA.0000000000000813