Ignite Creation Date:
2025-12-24 @ 1:28 PM
Ignite Modification Date:
2025-12-28 @ 1:23 PM
Study NCT ID:
NCT05629195
Status:
UNKNOWN
Last Update Posted:
2022-11-29
First Post:
2022-11-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Skin Laxity on the PICC
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 356}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2023-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-11-17', 'studyFirstSubmitDate': '2022-11-17', 'studyFirstSubmitQcDate': '2022-11-17', 'lastUpdatePostDateStruct': {'date': '2022-11-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'rate of PICC complications', 'timeFrame': '120 days', 'description': 'Including bleeding, subcutaneous congestion, lymphatic exudation, phlebitis (mechanical phlebitis, thrombophlebitis), infection (local infection, tunnel infection, catheter related blood flow infection), thrombus (symptomatic thrombus, asymptomatic thrombus), catheter ectopic, medical adhesive related skin damage, catheter damage and blockage, etc'}], 'secondaryOutcomes': [{'measure': 'time of PICC insertion', 'timeFrame': '1 hour', 'description': 'Time from the start of skin disinfection to the end of dressing fixation'}, {'measure': 'Success rate of catheterization', 'timeFrame': '1 hour', 'description': 'Judgment of successful catheterization: The catheterization is successful and the catheter is placed in an accurate position, that is, the tip of the catheter reaches within 1/3 of the lower part of the superior vena cava or near the junction of the right atrium.'}, {'measure': 'score of operation pain', 'timeFrame': '1 hour', 'description': 'Wong Banker facial expression scale was used. This method uses 6 facial expressions from smile to cry to express the degree of pain: 0 points for no pain, 1 point for slight pain, 2 points for some pain, 3 points for very pain, 4 points for severe pain, and 5 points for unbearable pain'}, {'measure': 'rate of unplanned extubation', 'timeFrame': '120 days', 'description': 'Extubation after abnormal treatment'}, {'measure': 'rate of difficulty in decannulation', 'timeFrame': '120 days', 'description': 'Probability of failure to pull out PICC due to vasospasm, adhesion with thrombus, wrapping of fibrin sheath, etc'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Complications; Catheter']}, 'descriptionModule': {'briefSummary': 'To evaluate the clinical effect of tunneled PICC by comparing the rate of complications of the two groups of patients (tunneled PICC vs conventional PICC).', 'detailedDescription': 'In this study, tunneled PICC was compared with conventional PICC. Eligible subjects were randomly enrolled into the test group or control group by randomization (1:1), and observed and evaluated the occurrence of complications during and 7 ± 3 days, 30 ± 7 days, 60 ± 10 days, 90 ± 10 days, 120 ± 10 days (if any) after surgery and extubation at the end of treatment. To evaluate the clinical effect of tunneled PICC by comparing the rate of complications of the two groups of patients'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients ≥ 18 years old;\n* Patients who need PICC catheterization according to the doctor's advice;\n* There is no history of venous thrombosis, compression or blockage of superior vena cava, severe coagulation dysfunction and other contraindications for PICC catheterization;\n* There is no serious cardiovascular disease, such as atrial fibrillation, pulmonary heart disease and other patients with abnormal P wave, and severe heart block before catheterization\n* Patients who have not participated in other clinical studies;\n* Patients who voluntarily participate in this clinical study and can cooperate with clinical follow-up\n\nExclusion Criteria:\n\n* Known allergy to catheter material;\n* The puncture site has a history of infection, injury and radiotherapy;\n* The puncture site has a history of venous thrombosis or surgery;\n* Severe abnormal bleeding and coagulation function;\n* Superior vena cava compression syndrome;\n* Surgical side limbs of breast cancer patients undergoing radical mastectomy or axillary lymph node dissection;\n* The ipsilateral limb of the pacemaker and the arteriovenous fistula;\n* patient or her/his family members refuse to sign the informed consent form."}, 'identificationModule': {'nctId': 'NCT05629195', 'acronym': 'PICC', 'briefTitle': 'The Effect of Skin Laxity on the PICC', 'organization': {'class': 'OTHER', 'fullName': "First People's Hospital of Foshan"}, 'officialTitle': 'Study on the Influence of Skin Laxity on the Application Effect of Different PICC Catheterization Methods', 'orgStudyIdInfo': {'id': 'foshan202271'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'tunneled PICC', 'description': 'Placement of PICC catheter through tunnel technology', 'interventionNames': ['Device: tunneled PICC']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'conventional PICC', 'description': 'Placement of PICC catheter through conventional technology', 'interventionNames': ['Device: tunneled PICC']}], 'interventions': [{'name': 'tunneled PICC', 'type': 'DEVICE', 'description': 'PICC catheter is inserted into the superior vena cava through the upper brachial vein by establishing a subcutaneous tunnel', 'armGroupLabels': ['conventional PICC', 'tunneled PICC']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "First People's Hospital of Foshan", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'nurse', 'investigatorFullName': 'Yingshan Zheng', 'investigatorAffiliation': "First People's Hospital of Foshan"}}}}