Ignite Creation Date:
2025-12-24 @ 10:00 PM
Ignite Modification Date:
2025-12-31 @ 2:58 AM
Study NCT ID:
NCT04466332
Status:
COMPLETED
Last Update Posted:
2022-09-28
First Post:
2020-07-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Two ECG Guided PICC Insertion Techniques
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006963', 'term': 'Hyperphagia'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 320}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2021-08-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-27', 'studyFirstSubmitDate': '2020-07-07', 'studyFirstSubmitQcDate': '2020-07-07', 'lastUpdatePostDateStruct': {'date': '2022-09-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Distance from catheter tip to cavo-atrial junction (CAJ)', 'timeFrame': 'At the end of intervention', 'description': 'At the end of intervention tip position is measured on chest fluoroscopic X-ray.\n\nAbsolute distance in centimeters from tip to CAJ is measured on the image'}], 'secondaryOutcomes': [{'measure': 'Length of the outgoing catheter', 'timeFrame': 'At the end of intervention', 'description': 'Length of the outgoing catheter at the entry point near the bend of the elbow in centimeters'}, {'measure': 'Haemostasis time', 'timeFrame': 'At the end of intervention', 'description': 'Haemostasis time at the puncture site entry point (0, 1, 3, 5, \\>5 minutes)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PICC', 'ECG guidance', 'Central Venous Catheter', 'Catheterization'], 'conditions': ['Central Venous Access', 'Long Term Antibiotics', 'Chemotherapy', 'Total Parenteral Nutrition']}, 'descriptionModule': {'briefSummary': 'The aim of our study is to compare two ECG techniques for guiding Peripherally Inserted Central Venous Cather (PICC) in terms of accuracy of the final position of the catheter tip.', 'detailedDescription': 'One technique uses ECG signal transmission with saline water and allows external catheter length adjustment while the other technique uses a guidewire for signal transmission thus requiring prior catheter length adjustment'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Informed Consent as documented by signature (Appendix Informed Consent Form)\n* Adult \\> 18 years\n* Referred to the interventional radiology department for PICC insertion\n\nExclusion Criteria:\n\n* Known or suspected non-compliance\n* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant\n* Previous enrolment into the current study\n* Enrolment of the investigator, his/her family members, employees and other dependent persons\n* Impairment of the heart rhythm changing the presentation of the P wave (atrial fibrillation, atrial flutter, severe tachycardia, pacemaker driven rhythm)\n* Enrolled in conflicting research study\n* Weight\\> 150 kg, technical limit for the fluoroscopy table\n* Impossibility of obtaining informed consent\n* Refusal to be informed in the event of a chance discovery'}, 'identificationModule': {'nctId': 'NCT04466332', 'briefTitle': 'Comparison of Two ECG Guided PICC Insertion Techniques', 'organization': {'class': 'OTHER', 'fullName': 'University of Lausanne'}, 'officialTitle': 'Comparison of Two ECG Guided PICC Insertion Techniques, a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2020-00583'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Saline ECG with Pilot Tip Location System', 'description': 'PICC insertion using electrocardiographic guidance Pilot Tip Location System (TLS), ECG signal transmission is with saline water', 'interventionNames': ['Device: LifeCath-CT PICC easy™ (Vygon)']}, {'type': 'EXPERIMENTAL', 'label': 'Guidewire ECG with Sherlock Tip Confirmation System', 'description': 'PICC insertion using electrocardiographic guidance Sherlock 3CG Tip Confirmation System (TCS), ECG signal transmission is with guidewire', 'interventionNames': ['Device: PowerPICC-SOLO® (C.R. Bard)']}], 'interventions': [{'name': 'LifeCath-CT PICC easy™ (Vygon)', 'type': 'DEVICE', 'description': "ECG electrodes are placed on patient's chest ensuring that there is a distinguishable P-wave.\n\nUpper arm selection is based on vein diameter and dominance, ultrasound is used to identify a suitable vein.\n\nThe patient is prepared using a maximal sterile barrier approach. The catheter is inserted into one of the veins (75-90° arm abduction) using ultrasound and modified Seldinger technique.\n\nThe PICC is advanced into the central circulation and used as an intracavitary electrode (connection with Vygocard2™). Saline water instilled through the catheter ensures conductivity.\n\nThe ECG is then used until displayed intracavitary P-wave has a maximal height without negative deflexion. Catheter is left at this point (cavo atrial junction).\n\nThe PICC hub side is then trimmed and the catheter part connected. The PICC is caped with a neutral bidirectional valve.\n\nThe puncture site is dressed and catheter stabilized. Chest Xray is obtained immediately after insertion to assess the position.", 'armGroupLabels': ['Saline ECG with Pilot Tip Location System']}, {'name': 'PowerPICC-SOLO® (C.R. Bard)', 'type': 'DEVICE', 'description': "ECG electrodes are placed on patients chest ensuring that there is a distinguishable P-wave.\n\nUpper arm selection is based on vein diameter and dominance, ultrasound is used to identify suitable vein.\n\nThe patient is prepared using a maximal sterile barrier approach. The catheter is inserted into one of the veins (75-90° arm abduction) using ultrasound and modified Seldinger technique.\n\nThe catheter's free end is cut to the anticipated length using anthropometric measurements (insertion/axillary crease+axillary crease/sternal notch+13cm) and the preloaded magnetic-tipped stylet (serving as intracavitary electrode) is put inside.\n\nThe PICC is advanced into central veins until intravascular ECG displays a P-wave with maximal height without negative deflexion. Catheter is left at this point (cavo atrial junction).\n\nThe puncture site is dressed and catheter stabilized. Chest Xray is obtained immediately after insertion to assess position.", 'armGroupLabels': ['Guidewire ECG with Sherlock Tip Confirmation System']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1011', 'city': 'Lausanne', 'state': 'Canton of Vaud', 'country': 'Switzerland', 'facility': 'CHUV', 'geoPoint': {'lat': 46.516, 'lon': 6.63282}}], 'overallOfficials': [{'name': 'Salah Dine Qanadli, Prof. MD PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'UNIL-CHUV'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Lausanne', 'class': 'OTHER'}, 'collaborators': [{'name': 'Centre Hospitalier Universitaire Vaudois', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor MD PhD', 'investigatorFullName': 'Salah D. Qanadli, MD, PhD', 'investigatorAffiliation': 'University of Lausanne'}}}}