Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-25 @ 11:46 PM
Study NCT ID:
NCT07182994
Status:
COMPLETED
Last Update Posted:
2025-09-19
First Post:
2025-08-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immobilization During Peripheral Venous Catheter Placement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 322}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2023-03-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-13', 'studyFirstSubmitDate': '2025-08-29', 'studyFirstSubmitQcDate': '2025-09-13', 'lastUpdatePostDateStruct': {'date': '2025-09-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'success of peripheral venous line cannulation on the first attempt', 'timeFrame': 'From enrollment to the end of the procedure (15 minutes)', 'description': 'Percentage of successful cannulations on the first attempt, as assessed by the registered nurse.'}], 'secondaryOutcomes': [{'measure': 'Number of attempts required', 'timeFrame': 'From enrollment to the end of the procedure (15 minutes)', 'description': 'Number of cannulation attempts until successful catheterization.'}, {'measure': 'Time to successful catheterization', 'timeFrame': 'From start of procedure until catheter placement (≤15 minutes)', 'description': 'Time in minutes from first attempt to successful catheter placement'}, {'measure': "Nurse's assessment of patient's pain", 'timeFrame': 'Immediately after procedure', 'description': 'Pain assessed by the nurse using a validated age-appropriate pediatric pain scale'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pediatrics', 'emergency medical services', 'immobilization', 'catheter', 'nurses, pediatric'], 'conditions': ['Pediatrics', 'Immobilization']}, 'descriptionModule': {'briefSummary': 'Aim: To determine the most effective type of upper limb immobilization in the cannulation of a peripheral venous line in the pediatric emergency department.\n\nMethods: Randomized clinical trial with 322 patients conducted in a tertiary pediatric emergency. The impact of two types of restraints (immobilization of the elbow joint versus arm restraint, without immobilization of the elbow joint) on the success of the technique was analyzed. Multivariate analysis was used to analyze the impact of other variables (weight, age, movements, pain) on the success of the technique.', 'detailedDescription': 'A study will be conducted in a Spanish tertiary hospital to assess the holding technique for peripheral venous catheterization in pediatric patients presenting to the pediatric emergency department. The nursing staff will be responsible for implementing the study protocol, data collection, and subsequent analysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'minimumAge': '1 Day', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pediatric patients at emergency department that need a peripheral venous line\n\nExclusion Criteria:\n\n* Critically ill patient'}, 'identificationModule': {'nctId': 'NCT07182994', 'briefTitle': 'Immobilization During Peripheral Venous Catheter Placement', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Universitario La Paz'}, 'officialTitle': 'Immobilization During Peripheral Venous Catheter Placement in Paediatric Emergency Care: a Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'Immobilization catheter'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'elbow joint immobilization', 'description': 'Pediatric patients undergo cannulation of a peripheral venous line with immobilization of the elbow joint', 'interventionNames': ['Procedure: Elbow joint immobilization']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'arm restraint without immobilization of the elbow joint', 'description': 'Pediatric patients undergo cannulation of a peripheral venous line with arm restraint, but the elbow joint is not immobilized.', 'interventionNames': ['Procedure: Arm restraint without elbow immobilization']}], 'interventions': [{'name': 'Elbow joint immobilization', 'type': 'PROCEDURE', 'description': 'Immobilization of the elbow joint during peripheral venous line cannulation in pediatric patients on the success of the technique', 'armGroupLabels': ['elbow joint immobilization']}, {'name': 'Arm restraint without elbow immobilization', 'type': 'PROCEDURE', 'description': 'Use of arm restraint without immobilization of the elbow joint during peripheral venous line cannulation in pediatric patients.', 'armGroupLabels': ['arm restraint without immobilization of the elbow joint']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28022', 'city': 'Madrid', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario La Paz', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data (IPD) will not be shared because the study involves a small sample of pediatric patients in a single hospital. Sharing the data could compromise confidentiality despite de-identification, and the main outcomes will be disseminated through peer-reviewed publications and conference presentations.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Universitario La Paz', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Ana Martínez Serrano', 'investigatorAffiliation': 'Hospital Universitario La Paz'}}}}