Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2026-02-20 @ 10:58 PM
Study NCT ID:
NCT03953105
Status:
COMPLETED
Last Update Posted:
2024-12-12
First Post:
2019-05-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Electronic Pediatric Emergency Ruler vs the Broselow Tape.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2019-02-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-11', 'studyFirstSubmitDate': '2019-05-14', 'studyFirstSubmitQcDate': '2019-05-14', 'lastUpdatePostDateStruct': {'date': '2024-12-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-02-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to identification', 'timeFrame': 'During simulation, approximately 30 minutes', 'description': 'Time needed to identify the four defined parameters'}], 'secondaryOutcomes': [{'measure': 'Correctness', 'timeFrame': 'During simulation, approximately 30 minutes', 'description': 'Correctness of the identified Parameter. The from the participant identified value is compared with the per value defined correctly based on the manikin size.'}, {'measure': 'Percentage deviation', 'timeFrame': 'During simulation, approximately 30 minutes', 'description': 'If the Parameter was identified incorrectly, a percentage deviation of the identified value from the correct value will be calculated'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Weight estimation', 'Patient safety'], 'conditions': ['Time Until Identification of Defined Parameter']}, 'descriptionModule': {'briefSummary': 'Comparison of two different pediatric emergency rulers for length-based body weight estimation in pediatric emergencies.\n\nPrimary outcome is the time needed to identify four defined parameters from the pediatric emergency rulers during a low-fidelity pediatric emergency scenario (cardiac arrest). Secondary outcome is the correctness of the identified parameters and the percentage deviation from the correct value.', 'detailedDescription': 'Medical team members (Paramedics, EMT) of Schutz und Rettung Zurich, Zurich Switzerland were asked to participate in this study. If they were not familiar with one of the three devices written informed consent was obtained and the participant included in this study. This exclusion criteria was necessary to prevent a bias by already knowing where to find the information of interest.\n\nThe pediatric emergency rulers investigated were the electronic Pediatric Emergency Ruler (ePER) and the Broselow Tape (BT)\n\nAll participants were instructed for the use of the two pediatric emergency rulers and were given time to practice with each device using one training manikin (Sim-Baby)\n\nAfter they felt comfortable using the devices the participants were randomly assigned to use each device only once with one of two different manikins:\n\nResusci Baby, Laerdal/Dräger Medical Switzerland AG, Liebefeld, Switzerland Ambu® Junior, Ambu® GmbH, Bad Nauheim, Germany\n\nEach manikin was only used once for the same participant. This guaranteed that the participants were blinded for the manikins.\n\nThe low-fidelity pediatric emergency scenario simulated was a cardiac arrest and the participants were asked to identify the following information from the pediatric emergency rulers:\n\nEstimated body weight Joule suggested for defibrillation Recommended epinephrine dose Suggested endotracheal tube size\n\nParticipants stood aside from the manikin with a pediatric emergency ruler in their hand. After they stated they were ready, the facilitator started a countdown from three and gave the command to start. This setting was identical for all two pediatric emergency rulers and all two manikins. The time until each parameter was identified and the value of the parameter were recorded.\n\nPrimary outcome was the time needed to identify the four above defined parameters. Secondary outcome was the correctness of the identified parameters and the percentage deviation from the correct value.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Medical team members (Paramedics, EMT) of Schutz und Rettung Zurich, Zurich, Switzerland', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Medical team members (Paramedics, EMT) of Schutz und Rettung Zurich, Zurich, Switzerland\n* Written informed consent\n\nExclusion Criteria:\n\n* Having worked with one of the pediatric emergency rulers and knowing where to find the defined parameters'}, 'identificationModule': {'nctId': 'NCT03953105', 'acronym': 'ePERvsBT', 'briefTitle': 'Electronic Pediatric Emergency Ruler vs the Broselow Tape.', 'organization': {'class': 'OTHER', 'fullName': "University Children's Hospital, Zurich"}, 'officialTitle': 'Electronic Pediatric Emergency Ruler vs the Broselow Tape in a Simulated Pediatric Emergency Scenario', 'orgStudyIdInfo': {'id': 'ePER vs BT'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Resusci Baby', 'description': 'Resusci Baby used for the simulated emergency scenario', 'interventionNames': ['Device: ePER', 'Device: BT']}, {'label': 'Ambu® Junior', 'description': 'Ambu® Junior used for the simulated emergency scenario', 'interventionNames': ['Device: ePER', 'Device: BT']}], 'interventions': [{'name': 'ePER', 'type': 'DEVICE', 'description': 'usind the ePER for weight estimation and suggestion of the defined parameter', 'armGroupLabels': ['Ambu® Junior', 'Resusci Baby']}, {'name': 'BT', 'type': 'DEVICE', 'description': 'usind the BT for weight estimation and suggestion of the defined parameter', 'armGroupLabels': ['Ambu® Junior', 'Resusci Baby']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8032', 'city': 'Zurich', 'country': 'Switzerland', 'facility': "University Childrens Hospital, Department of Anaesthesia and Children's Research Centre", 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': 'Alexander R Schmidt, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Department of Anaesthesia and Children's Research Centre, University Children's Hospital, Zurich, Switzerland"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "University Children's Hospital, Zurich", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}