Ignite Creation Date:
2025-12-24 @ 5:48 PM
Ignite Modification Date:
2026-01-01 @ 1:24 PM
Study NCT ID:
NCT05127668
Status:
COMPLETED
Last Update Posted:
2021-11-19
First Post:
2021-09-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of AirGLovE in Difficult Venous Access
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-03-25', 'size': 663050, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-09-14T09:48', 'hasProtocol': True}, {'date': '2019-04-30', 'size': 518061, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-09-14T09:54', 'hasProtocol': False}, {'date': '2019-03-25', 'size': 241502, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_002.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2021-09-14T09:49', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The investigator and reviewer were masked to the results'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Prospective cross-sectional comparative study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2019-04-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-08', 'studyFirstSubmitDate': '2021-09-14', 'studyFirstSubmitQcDate': '2021-11-08', 'lastUpdatePostDateStruct': {'date': '2021-11-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Name of Measurement: Change in measurement of vein diameter by ultrasound', 'timeFrame': 'Change from baseline measurements taken within 2 minutes of the intervention', 'description': 'MEASUREMENT TOOL: GE Logic S8 multi-frequency linear-array transducer (L6-15MHz), two-dimension B-mode ultrasound'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cannulation,', 'Chemotherapy', 'Difficult venous access', 'Difficult venepuncture', 'Cancer'], 'conditions': ['Cancer']}, 'descriptionModule': {'briefSummary': 'To determine whether Airglove™ warming device dilates upper limb veins to the same degree as the warm water immersion (WWI) method.', 'detailedDescription': 'Failure to cannulate to gain intra-venous access is a common occurrence in patients undergoing chemotherapy, obese patients, intravenous drug users and those with chronic medical problems leading to peripheral venous collapse. Difficulty in gaining IV-access is a serious medical consequence since important life-saving drugs, fluids, blood transfusions, and other medication are usually given via the intravenous route. Most chemotherapy units in the UK rely on venous dilation by immersing the forearm of patients with "difficult to cannulate veins" (DTCV) into a bucket of warm water. There are however, limitations in this method such as controlling water temperature and ensuring proper sterility.\n\nA new device Airglove™ has been developed which directs warm air over the forearm in a polythene sleeve causing venodilation. Preliminary studies in chemotherapy patients suggest that the Airglove™ causes venodilation to the extent of the warm water immersion technique, however further evidence is required with testing on normal healthy volunteers.\n\nAims and Objectives:\n\nTo determine whether Airglove™ warming device dilates upper limb veins to the same degree as the warm water immersion (WWI) method.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Participants \\> 18 years old\n* Able to give written informed consent\n* Able to understand and complete questionnaire forms independently\n\nExclusion Criteria:\n\n* Participants \\< 18 years old\n* Participants with cancer and/or undergoing chemotherapy\n* Participants with difficult to cannulate veins (DTCV)\n* Participants with lymphoedema in either hand\n* Participants with pre-existing Raynaud's disease\n* Participants with Diabetes (Type 1 \\& 2)\n* Participants with generalised anxiety disorder\n* Participants with diagnosis of hypertension\n* Participants with any cardiovascular disease, previous stroke, episodes of DVT, recent treatment for venous thromboembolism (VTE), recently administered heparin, participants on warfarin or any anticoagulant treatment (including NOACs).\n* Participants not able to give written informed consent\n* Participants not able to comprehend or complete questionnaire forms independently"}, 'identificationModule': {'nctId': 'NCT05127668', 'acronym': 'EAGLE', 'briefTitle': 'Efficacy of AirGLovE in Difficult Venous Access', 'organization': {'class': 'OTHER', 'fullName': 'Glasgow Caledonian University'}, 'officialTitle': 'Assessment by Ultrasound of the Degree of Venous Dilation, Comparison Between Venodilation by Airglove (TM) Versus Warm-water Immersion (WWI)', 'orgStudyIdInfo': {'id': 'HLS/PSWAHS/18/168'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Airglove arm', 'description': 'Participants on the airglove arm were subjected to warming of their forearms using the Airglove device at 38.5oC.', 'interventionNames': ['Device: Airglove (TM)']}, {'type': 'EXPERIMENTAL', 'label': 'Warm-water Immersion arm', 'description': 'Participants on the WWI arm were subjected to warming by immersing their forearms into a bucket of warm water at 38.5oC.', 'interventionNames': ['Device: Warm-water Immersion']}], 'interventions': [{'name': 'Airglove (TM)', 'type': 'DEVICE', 'description': 'A sterile polythene-balloon was inflated around the forearm using the AirGloveTM to 38.5oC at setting number-3 for 3 minutes, then removed and the degree of venodilation assessed by ultrasound.', 'armGroupLabels': ['Airglove arm']}, {'name': 'Warm-water Immersion', 'type': 'DEVICE', 'description': 'The upper limbs (to the level of mid-humerus) of participants were immersed in a container filled with a mix of cold-and warm tap-water to 38.5oC for 3 minutes in the WWI method. Arms were towel-dried, and the degree of venodilation was assessed by ultrasound', 'armGroupLabels': ['Warm-water Immersion arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'G4 0BA', 'city': 'Glasgow', 'state': 'South Lanarkshire', 'country': 'United Kingdom', 'facility': 'Glasgow Calenonian University', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Glasgow Caledonian University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}