Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2025-12-26 @ 3:30 AM
Study NCT ID:
NCT04527120
Status:
COMPLETED
Last Update Posted:
2020-10-01
First Post:
2020-07-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Indigenously Developed Ultrasound Phantom Model
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The examiners, examinees and statistician would be blinded to the nature of the model.\n\nThe model would be matched in colour shape and size with the commercially available model. The models would be covered by a plastic surgical drape, with a label on top that said model A or model B.\n\nThe models identity would be known only to the team leader. One the coin toss is complete and model allocated, the allocation would be marked unto a sealed envelope which would be opened only after data entry and analysis.\n\nAny untoward event needing unmasking of the models like damage to the model, warranting replacement was also carried out by the team leader.'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2020-07-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-30', 'studyFirstSubmitDate': '2020-07-25', 'studyFirstSubmitQcDate': '2020-08-21', 'lastUpdatePostDateStruct': {'date': '2020-10-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Time taken to visualise needle tip and time taken to puncture vessel and draw fluid in out of plane approach and in plane approach', 'timeFrame': '6 hours', 'description': 'Time taken to sonologically visualise the cannulating needles tip and time taken to puncture vessel and aspirate fluid in out of plane approach and in plane approach measured in seconds'}], 'primaryOutcomes': [{'measure': 'Comparative scoring of the two ultrasound phantom models', 'timeFrame': '6 hours', 'description': 'Comparison of the two ultrasound model assessed on a five point Likert scale (1- worst score, 5- best score) in terms of resemblance, tactile feed back, artefacts and ease of use done at the end of the study.'}], 'secondaryOutcomes': [{'measure': 'Confidence in performing and teaching ultrasound guided vascular access using in plane approach', 'timeFrame': '6 hours', 'description': 'Post workshop confidence level change in performing and teaching needle tracking and vascular access, with in plane approach, assessed on a five point Likert scale (1- least confident score, 5- most confident)'}, {'measure': 'Confidence in performing and teaching ultrasound guided vascular access using out of plane approach', 'timeFrame': '6 hours', 'description': 'Post workshop confidence level change in performing and teaching needle tracking and vascular access, with out of plane approach, assessed on a five point Likert scale (1- least confident score, 5- most confident)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ultrasonography', 'vascular access', 'phantom model'], 'conditions': ['Simulation Training']}, 'descriptionModule': {'briefSummary': 'Point of care ultrasound (POCUS) is used ever more increasingly across the emergency medicine departments in India.\n\nGuided procedures like nerve blocks, vascular access, abscess drainage and foreign body exploration are done more conveniently and efficiently utilising visualisation under ultra sonography.\n\nSeveral training models are available commercially that aids in training the novice and expert in the field alike. The commercially available models are expensive and inaccessible for most, while the utility of POCUS in Emergency Department (ED) is on the rise. This has lead people to experiment with various models for training which ranges from basic gelatin moulds to ballistic gel. There are only a few studies that compare these with the commercially available products for educational purposes.\n\nThe home made models are cheaper and more easily procurable for training making it a relatively favourable choice in financially constrained situations. The investigators have been using a gelatine based training model to train their emergency medicine residents for many years. In this study they intend to assess whether their indigenously developed ultrasound phantom model is comparable to commercially available models for vascular access training.They also sought to assess the better preliminary teaching model for ultrasound guided vascular access: in-plane or out-of-plane approach?'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- All the participants of the ultrasound training module who underwent the vascular access course were considered eligible to participate if they consented for the study\n\nExclusion Criteria:\n\n\\- Participants of the ultrasound training module who underwent the vascular access course not giving consent to participate or\n\nParticipant ultrasound training module who underwent the vascular access course withdrawing consent for using the data'}, 'identificationModule': {'nctId': 'NCT04527120', 'acronym': 'IDUP', 'briefTitle': 'Indigenously Developed Ultrasound Phantom Model', 'organization': {'class': 'OTHER', 'fullName': 'Jubilee Mission Medical College and Research Institute'}, 'officialTitle': 'Indigenously Developed Ultrasound Phantom Model vs a Commercially Available Training Model: a Randomised Triple Blind Study', 'orgStudyIdInfo': {'id': '03/19/IEC/JMMC&RI'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Model A first and then B', 'description': 'Model A and B would be randomly allotted to commercial model and IDUP. Intervention limb would involve performing on sequentially on the commercial and IDUP, following which a feed back of the candidates would be recorded about their performance on the same with respect to sonological appearance, tactile feedback, artefacts and ease of performing the procedure. Set time points (time to needle tip visualisation, time to puncture) and no of attempts before successful cannulation would be recorded by an assessor on a pre set proforma.', 'interventionNames': ['Other: indigenously developed ultrasound phantom (IDUP)']}, {'type': 'OTHER', 'label': 'Model B first and then A', 'description': 'Model A and B would be randomly allotted to commercial model and IDUP. Intervention limb would involve performing on sequentially on the commercial and IDUP, following which a feed back of the candidates would be recorded about their performance on the same with respect to sonological appearance, tactile feedback, artefacts and ease of performing the procedure. Set time points (time to needle tip visualisation, time to puncture) and no of attempts before successful cannulation would be recorded by an assessor on a pre set proforma.', 'interventionNames': ['Other: indigenously developed ultrasound phantom (IDUP)']}], 'interventions': [{'name': 'indigenously developed ultrasound phantom (IDUP)', 'type': 'OTHER', 'otherNames': ['Jubilee Phantom'], 'description': 'Ultrasound phantom model developed in the department of Emergency Medicine of Jubilee Mission Medical College, to train vascular access.', 'armGroupLabels': ['Model A first and then B', 'Model B first and then A']}]}, 'contactsLocationsModule': {'locations': [{'zip': '680005', 'city': 'Thrissur', 'state': 'Kerala', 'country': 'India', 'facility': 'Jubilee Mission Medical College and Research Institute', 'geoPoint': {'lat': 10.51667, 'lon': 76.21667}}], 'overallOfficials': [{'name': 'Vimal Krishanan S, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Manipal Academy of Higher education'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'After publication of the results in a journal, the result would be accessible to all, for a duration no less than one year', 'ipdSharing': 'YES', 'description': 'Participant data abstracted would be shared as excel sheet. The study protocol also would be shared', 'accessCriteria': 'google drive link would be shared'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jubilee Mission Medical College and Research Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'All India Institute of Medical Sciences', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor in the department of Emergency Medicine', 'investigatorFullName': 'Siju V Abraham, MD', 'investigatorAffiliation': 'Jubilee Mission Medical College and Research Institute'}}}}