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

NCT03730025 | Completed

• 1 other identifier: Novara2
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Neonatal Resuscitation; Heart Rate Assessment

Keywords

Heart rate; Assessment; Time; Resuscitation intervention

Outcome Measures

Primary Outcomes (1)

• Timing of the first HR communication.

  Time elapsed from birth to the first HR communication

  1 min

Secondary Outcomes (5)

• 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

Study Arms (2)

Auscultation plus NeoTapAS

EXPERIMENTAL

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.

Other: Auscultation plus NeoTapAS

Auscultation without NeoTapAS

ACTIVE COMPARATOR

Pediatric 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.

Other: Auscultation without NeoTapAS

Interventions

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 plus NeoTapAS

Auscultation without NeoTapAS OTHER

Auscultation without NeoTapAS

Auscultation without NeoTapAS

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital Padova: lead

Study Sites (1)

University of Piemonte Orientale

Novara, Italy

Location

Related Publications (6)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 DERIVED

MeSH Terms

Interventions

Auditory Perception

Intervention Hierarchy (Ancestors)

Vestibulocochlear Physiological Phenomena; Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 1, 2018
• First Posted: November 5, 2018
• Study Start: November 2, 2018
• Primary Completion: November 20, 2018
• Study Completion: November 20, 2018
• Last Updated: December 24, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

IT (1)