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

Not Applicable

Completed

• Conditions: Heart Rate Assessment; Neonatal Resuscitation
• Interventions: Other: Auscultation plus NeoTapAS; Other: Auscultation without NeoTapAS

• Registration Number: NCT03730025
• Lead Sponsor: University Hospital Padova

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.

Study Timeline

• Study First Submitted: 2018-11-01
• Study Start: 2018-11-02
• Study First Submitted QC: 2018-11-02
• Study First Posted: 2018-11-05
• Primary Completion: 2018-11-20
• Study Completion: 2018-11-20
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-20
• Last Update Posted: 2018-12-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Auscultation plus NeoTapAS	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	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.

Primary Outcome Measures

Name	Time	Method
Timing of the first HR communication.	1 min	Time elapsed from birth to the first HR communication

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Piemonte Orientale; 🇮🇹 Novara, Italy