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

Neonatal Resuscitation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03730025
• Other study ID #: Novara2
• Status: Completed
• Phase: N/A
• Start date: November 2, 2018
• Est. completion date: November 20, 2018

Study information

• Verified date: December 2018
• Source: University Hospital Padova
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 20, 2018
• Est. primary completion date: November 20, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Rate Assessment
• Neonatal Resuscitation

Intervention

Other:
• Auscultation plus NeoTapAS
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
Auscultation without NeoTapAS

Locations

Country	Name	City	State
Italy	University of Piemonte Orientale	Novara

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Padova

Country where clinical trial is conducted

Italy, 

References & Publications (5)

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. 2018 Sep 27. pii: fetalneonatal-2018-315408. doi: 10.1136/archdischild-2018-315408. [Epub ahead of print] — View 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. — View 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. — View Citation

Myrnerts Höök S, Pejovic NJ, Marrone G, Tylleskär T, Alfvén T. Accurate and fast neonatal heart rate assessment with a smartphone-based application - a manikin study. Acta Paediatr. 2018 Mar 31. doi: 10.1111/apa.14350. [Epub ahead of print] — View Citation

Wyllie J, Bruinenberg J, Roehr CC, Rüdiger 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Timing of the first HR communication.	Time elapsed from birth to the first HR communication	1 min
Secondary	Timing of the second HR communication		2 min
Secondary	Timing of the third HR communication		3 min
Secondary	Timing of the fourth HR communication		4 min
Secondary	Timing of resuscitation interventions (positive pressure ventilation, chest compressions, intubation and administration of first dose of adrenaline		10 min
Secondary	Timing of the fifth HR communication		5 min