Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2026-01-04 @ 12:09 AM
Study NCT ID:
NCT02958605
Status:
COMPLETED
Last Update Posted:
2017-10-06
First Post:
2016-11-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Smartphone Apps for Pediatric Resuscitation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013226', 'term': 'Status Epilepticus'}, {'id': 'D000707', 'term': 'Anaphylaxis'}], 'ancestors': [{'id': 'D012640', 'term': 'Seizures'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2017-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-04', 'studyFirstSubmitDate': '2016-11-04', 'studyFirstSubmitQcDate': '2016-11-05', 'lastUpdatePostDateStruct': {'date': '2017-10-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-11-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Medication error', 'timeFrame': 'During resuscitation', 'description': 'The primary outcome is the presence of a medication error. An error will be defined as a drug dose varying by more than 20% from the recommended dose or by incorrect route.'}], 'secondaryOutcomes': [{'measure': 'Proportion of tenfold error', 'timeFrame': 'During resuscitation', 'description': 'A tenfold error will be defined as a drug dose varying by a factor of 10 compared to the recommended dose.'}, {'measure': 'Time for prescribing the first medication', 'timeFrame': 'During the simulation (10 minutes)', 'description': 'Time from the beginning of the simulation and complete prescription (oral or written) of the first medication.'}, {'measure': 'Error in bolus medication', 'timeFrame': 'during simulation', 'description': 'An error in bolus medication will be defined as a drug dose varying by more than 20% from the recommended dose or by incorrect route.'}, {'measure': 'Error in perfusion medication', 'timeFrame': 'during simulation', 'description': 'An error in perfusion medication will be defined as a drug dose varying by more than 20% from the recommended dose. This can be related to a preparation error or a flow error.'}, {'measure': 'User satisfaction', 'timeFrame': '2 weeks', 'description': 'Satisfaction of the resident with both tools using a Visual analog scale'}, {'measure': 'User confidence', 'timeFrame': '2 weeks', 'description': 'Confidence of the resident while using both tools using a Visual analog scale'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Children', 'resuscitation', 'smartphone'], 'conditions': ['Status Epilepticus', 'Anaphylaxis']}, 'descriptionModule': {'briefSummary': 'Medication errors are common in children. Characteristics of errors during critical situations in the Emergency Department are ill-defined and might be more frequent than previously thought. However, optimal strategies to eliminate the risk of prescribing errors remain unknown.\n\nMany smartphone apps have been suggested over the last years with some of them designed to calculate medication dosage for children. The impact of these apps to decrease dosage error has never been evaluated in resuscitation setting.\n\nThe aim of the study is to evaluate whether the use of a smartphone application designed to calculate medication doses decreases prescribing errors among residents during pediatric simulated resuscitations.\n\nThis will be a crossover-randomized trial using high fidelity simulation among 40 residents rotating in the pediatric emergency department.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Residents (PGY1 to PGY4)\n* Completing a rotation in pediatric emergency\n\nExclusion Criteria:\n\n* Residents who previously participated in this study'}, 'identificationModule': {'nctId': 'NCT02958605', 'acronym': 'SMARTER', 'briefTitle': 'Smartphone Apps for Pediatric Resuscitation', 'organization': {'class': 'OTHER', 'fullName': "St. Justine's Hospital"}, 'officialTitle': 'Smartphone Medical Applications to Reduce Treatment Dosage Errors in Pediatric Resuscitation; a Randomized Simulation Trial', 'orgStudyIdInfo': {'id': 'SMARTER1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Smartphone', 'description': 'Smartphone application', 'interventionNames': ['Device: Smartphone apps']}, {'type': 'EXPERIMENTAL', 'label': 'Handbook', 'description': 'Resuscitation handbook who provides drug dosages for each weight for children. For example, at the page of 15 kg, it is written that the dosage of epinephrin is 1.5 cc of 1: 10 000.', 'interventionNames': ['Device: Handbook']}], 'interventions': [{'name': 'Smartphone apps', 'type': 'DEVICE', 'description': 'If already own a smartphone application dedicated to calculate medication dosage for children, the participant will be allowed to use his/her own application. Otherwise, the resident will be offered to chose among a list of applications paid by the research team (PediSafe, PediStat, Palm Pedi, Safedose, EZdrip peds). He/she will be instructed to practice with a few time at home before doing the simulations.', 'armGroupLabels': ['Smartphone']}, {'name': 'Handbook', 'type': 'DEVICE', 'description': 'Resuscitation handbook who provides drug dosages for each weight for children. For example, at the page of 15 kg, it is written that the dosage of epinephrin is 1.5 cc of 1: 10 000.', 'armGroupLabels': ['Handbook']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H3T1C5', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'CHU Sainte-Justine', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "St. Justine's Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': 'Canadian Medical Protective Association', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Jocelyn Gravel', 'investigatorAffiliation': "St. Justine's Hospital"}}}}