Impact of a Mobile Application for Heart Rate Assessment in Simulated Neonatal Resuscitation

NCT03730025 — Not applicable, Completed, 60 participants, University Hospital Padova

ClinicalTrials Daily  ·  Areas  ·  Conditions  ·  Drugs  ·  Sponsors  ·  

Impact of a Mobile Application for Heart Rate Assessment in Simulated Neonatal Resuscitation: a Randomized Controlled Crossover Study

RegistryNCT03730025
StatusCompleted
PhaseNot applicable
Study typeInterventional; randomized, crossover, masking: single, diagnostic
Enrollment60 (Actual)
SponsorUniversity Hospital Padova (Other)
ConditionsNeonatal Resuscitation, Heart Rate Assessment
InterventionsAuscultation plus NeoTapAS, Auscultation without NeoTapAS (Other)
Datesstart 2018-11-02, primary completion 2018-11-20, completion 2018-11-20, first posted 2018-11-05, last updated 2018-12-24
Locations1 site in Italy

Related Papers Related Patents Related Grants Related Experts
All trials for Neonatal Resuscitation All trials for Heart Rate Assessment All trials of Auscultation plus NeoTapAS All trials of Auscultation without NeoTapAS

-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.

Expand all sections  ·  Collapse all

+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.

+Arms and interventions

ArmTypeInterventionsDescription
Auscultation plus NeoTapASExperimentalOther: Auscultation plus NeoTapASPediatric resident responsible for HR assessment will estimate the HR by listening to the praecordium with a stethoscope. When using NeoTapAS, he/she will simultaneously tap the same pace on the screen of an iPad with the NeoTapAS app installed and will verbally communicate the HR displayed on the screen.
Auscultation without NeoTapASActive comparatorOther: Auscultation without NeoTapASPediatric resident responsible for HR assessment will mentally calculate the HR based on auscultation (by counting the number of beats in 6 seconds and multiplying by 10) and will verbally communicate the calculated HR.
  • Auscultation plus NeoTapAS (Other): Pediatric resident responsible for HR assessment will estimate the HR by listening to the praecordium with a stethoscope. When using NeoTapAS, he/she will simultaneously tap the same pace on the screen of an iPad with the NeoTapAS app installed and will verbally communicate the HR displayed on the screen.
  • Auscultation without NeoTapAS (Other): Auscultation without NeoTapAS

+Outcome measures

Primary outcomes

  • Timing of the first HR communication. [1 min]: Time elapsed from birth to the first HR communication

Secondary outcomes

  • Timing of the second HR communication [2 min]
  • Timing of the third HR communication [3 min]
  • Timing of the fourth HR communication [4 min]
  • Timing of resuscitation interventions (positive pressure ventilation, chest compressions, intubation and administration of first dose of adrenaline [10 min]
  • Timing of the fifth HR communication [5 min]

+Eligibility

Sex: All, accepts healthy volunteers

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

+Locations (1)

FacilityCityCountryStatus
University of Piemonte OrientaleNovaraItaly

+Publications

  • 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. PMID 30262463
  • 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. PMID 26477415
  • 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. PMID 29604115
  • 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. PMID 29802102
  • 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. PMID 22925993
  • Results publication: 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. PMID 31101662