Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2025-12-25 @ 10:58 PM
Study NCT ID:
NCT04412967
Status:
COMPLETED
Last Update Posted:
2020-06-30
First Post:
2020-05-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Nurse-led Placement of Peripheral Venous Catheters in Overweight Patients Using Standard or Dynamic Ultrasound-guided Technique
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D004630', 'term': 'Emergencies'}], 'ancestors': [{'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-06-26', 'size': 527052, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2020-06-26T07:38', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 89}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2018-06-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-26', 'studyFirstSubmitDate': '2020-05-27', 'studyFirstSubmitQcDate': '2020-06-01', 'lastUpdatePostDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to application', 'timeFrame': '1 hour', 'description': 'Application time was defined as the time from applying stasis to visible blood in the PVC flash-chamber.'}, {'measure': 'Number of cannulation attempts', 'timeFrame': '1 hour', 'description': 'The total number of cannulation attempts performed per patient'}], 'secondaryOutcomes': [{'measure': 'Patient satisfaction', 'timeFrame': '1 hour', 'description': 'The perceived satisfaction of the patient as indicated by Numeric Rating scale (NRS, 0 = not satisfied, 10 = maximum satisfaction)'}, {'measure': 'Perceived Pain', 'timeFrame': '1 hour', 'description': 'The perceived pain of the patient as indicated by Numeric Rating scale (NRS, 0 = no pain, 10 = the worst pain possible)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Nurse led', 'Ultrasound', 'Emergency department', 'Overweight', 'Obesity'], 'conditions': ['Overweight and Obesity', 'Emergencies']}, 'descriptionModule': {'briefSummary': 'Overweight and obesity may be associated with difficult intravenous access leading to longer procedure time and more placement attempts of peripheral venous catheters (PVC). Dynamic ultrasound-guided short-axis needle tip navigation (DUST) may facilitate the procedure.\n\nThis was a prospective, randomized, non-blinded study to compare time and placement attempts for nurse-led standard (ST) and ultrasound guided PVC placement in 90 emergency patients with a BMI ≥25kg/m2.\n\nConsenting patients were randomized at a 1:1 ratio to receive PVC by either ST or DUST.\n\nApplication time was defined as the time from applying stasis to visible blood in the PVC flash-chamber.\n\nNo difference in time was found (medians: ST 42 s; DUST 53.5 s, P = 0.535). There were on average 17 % less placement attempts in the DUST-group (median 1 attempt; Q1 = 1 Q3 = 1) compared to the ST-group (median 1 attempt; Q1 = 1 Q3 = 1.5), (p = 0.031). Patients reported no differences in perceived pain (p = 0.955) or perceived satisfaction (p = 0.342). Pain and subcutaneous infiltrations were the only side-effects reported (ST-group 6, DUST-group 5).\n\nDUST does not decrease time to functional PVC but reduces the number of PVC placement attempts in patients with BMI ≥25 kg/m2.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* REETS prioritization level of "Orange", "Yellow", "Green" or "Blue"\n* 18 years old\n* BMI ≥25 Kg/m2\n* Need of PVC according to Emergency department guidelines\n* Able to give written informed consent\n\nExclusion Criteria:\n\n* Unable or unwilling to provide informed consent\n* Life threatening patient status (REETS prioritization level of "Red")\n* Immunosuppression\n* Pregnant or lactating women\n* Blood infections\n* Puncture zone skin damaged (burns, eczema, infection)'}, 'identificationModule': {'nctId': 'NCT04412967', 'acronym': 'DUST', 'briefTitle': 'Nurse-led Placement of Peripheral Venous Catheters in Overweight Patients Using Standard or Dynamic Ultrasound-guided Technique', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Linkoeping'}, 'officialTitle': 'A Randomized, Controlled Comparison of Nurse-led Placement of Peripheral Venous Catheters in Overweight Patients Using Standard or Dynamic Ultrasound-guided Technique', 'orgStudyIdInfo': {'id': 'SE-2020 JG DUST'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Technique PVC placement', 'description': 'Standard PVC placement technique', 'interventionNames': ['Other: Standard technique of placing a PVC']}, {'type': 'EXPERIMENTAL', 'label': 'DUST', 'description': 'Dynamic ultrasound-guided short-axis needle tip navigation (DUST)', 'interventionNames': ['Device: Dynamic ultrasound-guided short-axis needle tip navigation']}], 'interventions': [{'name': 'Dynamic ultrasound-guided short-axis needle tip navigation', 'type': 'DEVICE', 'description': 'placement of peripheral venous catheters using ultrasound guided technique', 'armGroupLabels': ['DUST']}, {'name': 'Standard technique of placing a PVC', 'type': 'OTHER', 'description': 'Standard technique with palpation or Visual inspection of the pvc placement site', 'armGroupLabels': ['Standard Technique PVC placement']}]}, 'contactsLocationsModule': {'locations': [{'zip': '58185', 'city': 'Linköping', 'state': 'Östergötland County', 'country': 'Sweden', 'facility': 'University Hospital Linköping', 'geoPoint': {'lat': 58.41086, 'lon': 15.62157}}], 'overallOfficials': [{'name': 'Daniel Wilhelms, Phd', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Linkoeping University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Linkoeping', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Daniel Wilhelms', 'investigatorAffiliation': 'University Hospital, Linkoeping'}}}}