Ignite Creation Date:
2025-12-24 @ 7:43 PM
Ignite Modification Date:
2025-12-25 @ 5:21 PM
Study NCT ID:
NCT06165003
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-12-11
First Post:
2023-11-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Examination of Nurses' Use of Broselow Tape in Non-resuscitation Pediatric Emergency Department Practices
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'In the research, control group data will be collected first. After the data of the control group is collected, the data of the experimental group will be collected.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized controlled study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 246}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-11-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2025-12-26', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-08', 'studyFirstSubmitDate': '2023-11-25', 'studyFirstSubmitQcDate': '2023-12-08', 'lastUpdatePostDateStruct': {'date': '2023-12-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-26', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Selection by broselow Band', 'timeFrame': '2 year', 'description': 'Success of Broselow band selection'}], 'secondaryOutcomes': [{'measure': "Nurses' success rate in catheter applications", 'timeFrame': '2 year', 'description': 'Number of attempts'}, {'measure': "Nurses' success rate in catheter applications", 'timeFrame': '2 year', 'description': 'length of stay of the catheters'}, {'measure': "Nurses' success rate in catheter applications", 'timeFrame': '2 year', 'description': "nurses' completion of the catheter insertion process"}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['broselow tape', 'pediatric emergency department', 'nurse'], 'conditions': ['Pediatric']}, 'referencesModule': {'references': [{'pmid': '12937099', 'type': 'BACKGROUND', 'citation': 'Argall JA, Wright N, Mackway-Jones K, Jackson R. A comparison of two commonly used methods of weight estimation. Arch Dis Child. 2003 Sep;88(9):789-90. doi: 10.1136/adc.88.9.789. No abstract available.'}, {'pmid': '17213259', 'type': 'BACKGROUND', 'citation': 'Luscombe M, Owens B. Weight estimation in resuscitation: is the current formula still valid? Arch Dis Child. 2007 May;92(5):412-5. doi: 10.1136/adc.2006.107284. Epub 2007 Jan 9.'}, {'pmid': '41297189', 'type': 'DERIVED', 'citation': "Alaca A, Sari HY. An examination of how nurses' use of the Broselow tape affects patient safety during peripheral intravenous catheterization. Int Emerg Nurs. 2025 Nov 25;84:101712. doi: 10.1016/j.ienj.2025.101712. Online ahead of print."}]}, 'descriptionModule': {'briefSummary': "The patient's body weight is often taken as a basis when calculating drug doses and determining equipment sizes for pediatric patients presenting to the emergency department.\n\nThe methods used to determine body weight are the family's estimated weight, formulas for estimating weight according to age, or the Broselow band used to estimate weight according to height.\n\nWeight estimates that are incomplete compared to the child's actual body weight lead to medication errors, wrong material selection and prolongation of the procedure, resulting in increased mortality and morbidity.", 'detailedDescription': 'This study will be carried out to create an evidence-based practice in the selection of catheters to be used during peripheral intravenous catheter insertion, urinary catheter insertion, nasogastric/orogastric catheter insertion and aspiration in children using the Broselow band in non-resuscitation applications coming to the Pediatric Emergency Department.\n\nBy using the Boselow band in non-resuscitation pediatric emergency department applications, reducing the number of attempts and errors by ensuring the correct equipment selection in the procedures applied to patients, and increasing the success of the procedure; This will be done to ensure that the decisions taken by nurses using their experience and previous knowledge are more systematic.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children weighing 3 to 36 kg and 47 to 143 cm tall\n* Children aged 0-18\n* Patients coming to the emergency department for non-resuscitation procedures\n* Patients and their families who volunteer to participate in the research\n* Patients who will have a peripheral intravenous catheter inserted\n* Patients who will have a urinary catheter inserted\n* Patients who will have a nasogastric/orogastric catheter inserted\n* Patients who will undergo aspiration procedure\n\nExclusion Criteria:\n\n* Children weighing less than 3 kg and taller than 143 cm\n* Children with anomaly contractures that may prevent measurement during measurement with the Broselow tape\n* Patients with central venous catheter\n* Patients with peripheral intravenous catheters outside the pediatric emergency department\n* Patients who have a urinary catheter inserted outside the pediatric emergency department\n* Patients who have a nasogastric/orogastric catheter inserted outside the pediatric emergency department'}, 'identificationModule': {'nctId': 'NCT06165003', 'briefTitle': "Examination of Nurses' Use of Broselow Tape in Non-resuscitation Pediatric Emergency Department Practices", 'organization': {'class': 'OTHER', 'fullName': 'Izmir Katip Celebi University'}, 'officialTitle': "Examining the Effect of Nurses' Use of Broselow Tape in Non-resuscitation Pediatric Emergency Department Practices on Patient Safety", 'orgStudyIdInfo': {'id': 'Aslı alaca'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental group', 'description': 'Peripheral Intravenous Catheter Insertion Procedure - Broselow Band Selection - Experimental Group Urinary Catheter Insertion Procedure - Broselow Tape Selection - Experimental Group Aspiration process - Broselow Band Selection - Experimental group Nasogastric/Orogastric Catheter Insertion Procedure - Broselow Band Selection - Experimental Group', 'interventionNames': ['Other: Use of broselow tape']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'Peripheral Intravenous Catheter Insertion Procedure - Routine Application - Control Group Urinary Catheter Insertion Procedure - Routine Application - Control Group Aspiration process - Routine Application - Control Group Nasogastric/Orogastric Catheter Insertion Procedure - Routine Practice - Control Group'}], 'interventions': [{'name': 'Use of broselow tape', 'type': 'OTHER', 'description': "In the research, the nurse is the decision maker in the selection of the catheters to be used in the procedures (peripheral intravenous catheter insertion, urinary catheter insertion, aspiration procedure, nasogastric/orogastric catheter insertion) for the patients in the control group.\n\nIn these procedures, the nurse's choices will be evaluated as control group data as routine clinical practice.\n\nAfter the control group data is collected, Broselow tape will be used in the selection of catheters to be used in the procedures to be performed on the patients in the experimental group (peripheral intravenous catheter insertion, urinary catheter insertion, aspiration procedure, nasogastric/orogastric catheter insertion).\n\nOur research will be conducted to examine the effect of nurses' use of Broselow tape in non-resuscitation applications and to minimize errors and application disruptions in procedures involving nurses.", 'armGroupLabels': ['Experimental group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'ASLI ALACA', 'role': 'CONTACT', 'email': 'alaca_asli_1992@hotmail.com', 'phone': '05062741676'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Izmir Katip Celebi University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal İnvestigator', 'investigatorFullName': 'Aslı Alaca', 'investigatorAffiliation': 'Izmir Katip Celebi University'}}}}