Clinical trial NCT03730025: Impact of a Mobile Application for Heart Rate Assessment in Simulated Neonatal Resuscitation
Official title: Impact of a Mobile Application for Heart Rate Assessment in Simulated Neonatal Resuscitation: a Randomized Controlled Crossover Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neonatal Resuscitation
Heart Rate Assessment
Keywords: Heart rate
Assessment
Time
Resuscitation intervention
Lead sponsor: University Hospital Padova
Sponsor class: OTHER
First posted: 2018-11-05
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: NeoTapAdvancedSupport (NeoTapAS) is a free-of-charge mobile application that showed good accuracy in HR estimation. This study aims to evaluate the impact of NeoTapAS on timing of HR communication and of resuscitation interventions in a high fidelity simulation scenario.

Detailed description: Assessing the HR by auscultation can be limited due to imprecise auscultation and/or errors in mental computation, leading to inappropriate or delayed resuscitation. Previous studies evaluated a free-of-charge mobile application (NeoTapAdvancedSupport, NeoTapAS) to help HR assessment in a simulated scenario of neonatal resuscitation. NeoTapAS showed good accuracy in estimating HR and could be a useful tool in resource-constrained settings.

Another potential advantage of using NeoTapAS may be the anticipation of HR communication during resuscitation, because it avoids mental computation and possible errors due to the stressful situation. In addition, prompt HR assessment may lead to anticipating resuscitation interventions. However, these hypotheses remain to be demonstrated.

The aim of this study is to evaluate the promptness in HR communication using NeoTapAS compared with mental computation in a high-fidelity simulated newborn resuscitation scenario. In addition, the impact of NeoTapAS on timing of resuscitation procedures will be investigated.

Eligibility criteria: Inclusion Criteria:

* All pediatric residents from third to fifth year of residency of the University of Piemonte Orientale who were trained on neonatal resuscitation

Exclusion Criteria:

* Lack of EC approval
* Lack of consent to record the scenario and to use the data

Primary outcomes:
measure: Timing of the first HR communication.
timeFrame: 1 min
Secondary outcomes:
measure: Timing of the second HR communication
timeFrame: 2 min
measure: Timing of the third HR communication
timeFrame: 3 min
measure: Timing of the fourth HR communication
timeFrame: 4 min
measure: Timing of resuscitation interventions (positive pressure ventilation, chest compressions, intubation and administration of first dose of adrenaline
timeFrame: 10 min
measure: Timing of the fifth HR communication
timeFrame: 5 min
Other outcomes:
Locations:
city: Novara
country: Italy
facility: University of Piemonte Orientale
Study officials:
References:
citation: Binotti M, Cavallin F, Ingrassia PL, Pejovic NJ, Monzani A, Genoni G, Trevisanuto D. Heart rate assessment using NeoTapAdvancedSupport: a simulation study. Arch Dis Child Fetal Neonatal Ed. 2019 Jul;104(4):F440-F442. doi: 10.1136/archdischild-2018-315408. Epub 2018 Sep 27.
citation: Wyllie J, Bruinenberg J, Roehr CC, Rudiger M, Trevisanuto D, Urlesberger B. European Resuscitation Council Guidelines for Resuscitation 2015: Section 7. Resuscitation and support of transition of babies at birth. Resuscitation. 2015 Oct;95:249-63. doi: 10.1016/j.resuscitation.2015.07.029. Epub 2015 Oct 15. No abstract available.
citation: Myrnerts Hook S, Pejovic NJ, Marrone G, Tylleskar T, Alfven T. Accurate and fast neonatal heart rate assessment with a smartphone-based application - a manikin study. Acta Paediatr. 2018 Sep;107(9):1548-1554. doi: 10.1111/apa.14350. Epub 2018 Apr 22.
citation: Murphy MC, De Angelis L, McCarthy LK, O'Donnell CPF. Comparison of infant heart rate assessment by auscultation, ECG and oximetry in the delivery room. Arch Dis Child Fetal Neonatal Ed. 2018 Sep;103(5):F490-F492. doi: 10.1136/archdischild-2017-314367. Epub 2018 May 25.
citation: Chitkara R, Rajani AK, Oehlert JW, Lee HC, Epi MS, Halamek LP. The accuracy of human senses in the detection of neonatal heart rate during standardized simulated resuscitation: implications for delivery of care, training and technology design. Resuscitation. 2013 Mar;84(3):369-72. doi: 10.1016/j.resuscitation.2012.07.035. Epub 2012 Aug 25.
citation: Cavallin F, Binotti M, Ingrassia PL, Genoni G, Rizzollo S, Monzani A, Trevisanuto D. Impact of a mobile application for heart rate assessment in simulated neonatal resuscitation: a randomised controlled cross-over study. Arch Dis Child Fetal Neonatal Ed. 2020 Jan;105(1):41-44. doi: 10.1136/archdischild-2018-316757. Epub 2019 May 17.