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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03730025
Recruitment Status : Completed
First Posted : November 5, 2018
Last Update Posted : December 24, 2018
Sponsor:
Information provided by (Responsible Party):
Daniele Trevisanuto, 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.

Condition or disease Intervention/treatment Phase
Neonatal Resuscitation Heart Rate Assessment Other: Auscultation plus NeoTapAS Other: Auscultation without NeoTapAS Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Impact of a Mobile Application for Heart Rate Assessment in Simulated Neonatal Resuscitation: a Randomized Controlled Crossover Study
Actual Study Start Date : November 2, 2018
Actual Primary Completion Date : November 20, 2018
Actual Study Completion Date : November 20, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

Arm Intervention/treatment
Experimental: 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.
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.

Active Comparator: 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.
Other: Auscultation without NeoTapAS
Auscultation without NeoTapAS




Primary Outcome Measures :
  1. Timing of the first HR communication. [ Time Frame: 1 min ]
    Time elapsed from birth to the first HR communication


Secondary Outcome Measures :
  1. Timing of the second HR communication [ Time Frame: 2 min ]
  2. Timing of the third HR communication [ Time Frame: 3 min ]
  3. Timing of the fourth HR communication [ Time Frame: 4 min ]
  4. Timing of resuscitation interventions (positive pressure ventilation, chest compressions, intubation and administration of first dose of adrenaline [ Time Frame: 10 min ]
  5. Timing of the fifth HR communication [ Time Frame: 5 min ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03730025


Locations
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Italy
University of Piemonte Orientale
Novara, Italy
Sponsors and Collaborators
University Hospital Padova
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Daniele Trevisanuto, Professor, University Hospital Padova
ClinicalTrials.gov Identifier: NCT03730025    
Other Study ID Numbers: Novara2
First Posted: November 5, 2018    Key Record Dates
Last Update Posted: December 24, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Daniele Trevisanuto, University Hospital Padova:
Heart rate
Assessment
Time
Resuscitation intervention