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The Effect of Skin Laxity on the PICC (PICC)

Primary Purpose

Complications; Catheter

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
tunneled PICC
Sponsored by
First People's Hospital of Foshan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Complications; Catheter

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients ≥ 18 years old; Patients who need PICC catheterization according to the doctor's advice; There is no history of venous thrombosis, compression or blockage of superior vena cava, severe coagulation dysfunction and other contraindications for PICC catheterization; 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 Patients who have not participated in other clinical studies; Patients who voluntarily participate in this clinical study and can cooperate with clinical follow-up Exclusion Criteria: Known allergy to catheter material; The puncture site has a history of infection, injury and radiotherapy; The puncture site has a history of venous thrombosis or surgery; Severe abnormal bleeding and coagulation function; Superior vena cava compression syndrome; Surgical side limbs of breast cancer patients undergoing radical mastectomy or axillary lymph node dissection; The ipsilateral limb of the pacemaker and the arteriovenous fistula; patient or her/his family members refuse to sign the informed consent form.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    tunneled PICC

    conventional PICC

    Arm Description

    Placement of PICC catheter through tunnel technology

    Placement of PICC catheter through conventional technology

    Outcomes

    Primary Outcome Measures

    rate of PICC complications
    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

    Secondary Outcome Measures

    time of PICC insertion
    Time from the start of skin disinfection to the end of dressing fixation
    Success rate of catheterization
    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.
    score of operation pain
    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
    rate of unplanned extubation
    Extubation after abnormal treatment
    rate of difficulty in decannulation
    Probability of failure to pull out PICC due to vasospasm, adhesion with thrombus, wrapping of fibrin sheath, etc

    Full Information

    First Posted
    November 17, 2022
    Last Updated
    November 17, 2022
    Sponsor
    First People's Hospital of Foshan
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05629195
    Brief Title
    The Effect of Skin Laxity on the PICC
    Acronym
    PICC
    Official Title
    Study on the Influence of Skin Laxity on the Application Effect of Different PICC Catheterization Methods
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 1, 2022 (Anticipated)
    Primary Completion Date
    September 1, 2023 (Anticipated)
    Study Completion Date
    December 30, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    First People's Hospital of Foshan

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    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).
    Detailed Description
    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Complications; Catheter

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    356 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    tunneled PICC
    Arm Type
    Experimental
    Arm Description
    Placement of PICC catheter through tunnel technology
    Arm Title
    conventional PICC
    Arm Type
    Active Comparator
    Arm Description
    Placement of PICC catheter through conventional technology
    Intervention Type
    Device
    Intervention Name(s)
    tunneled PICC
    Intervention Description
    PICC catheter is inserted into the superior vena cava through the upper brachial vein by establishing a subcutaneous tunnel
    Primary Outcome Measure Information:
    Title
    rate of PICC complications
    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
    Time Frame
    120 days
    Secondary Outcome Measure Information:
    Title
    time of PICC insertion
    Description
    Time from the start of skin disinfection to the end of dressing fixation
    Time Frame
    1 hour
    Title
    Success rate of catheterization
    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.
    Time Frame
    1 hour
    Title
    score of operation pain
    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
    Time Frame
    1 hour
    Title
    rate of unplanned extubation
    Description
    Extubation after abnormal treatment
    Time Frame
    120 days
    Title
    rate of difficulty in decannulation
    Description
    Probability of failure to pull out PICC due to vasospasm, adhesion with thrombus, wrapping of fibrin sheath, etc
    Time Frame
    120 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients ≥ 18 years old; Patients who need PICC catheterization according to the doctor's advice; There is no history of venous thrombosis, compression or blockage of superior vena cava, severe coagulation dysfunction and other contraindications for PICC catheterization; 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 Patients who have not participated in other clinical studies; Patients who voluntarily participate in this clinical study and can cooperate with clinical follow-up Exclusion Criteria: Known allergy to catheter material; The puncture site has a history of infection, injury and radiotherapy; The puncture site has a history of venous thrombosis or surgery; Severe abnormal bleeding and coagulation function; Superior vena cava compression syndrome; Surgical side limbs of breast cancer patients undergoing radical mastectomy or axillary lymph node dissection; The ipsilateral limb of the pacemaker and the arteriovenous fistula; patient or her/his family members refuse to sign the informed consent form.

    12. IPD Sharing Statement

    Learn more about this trial

    The Effect of Skin Laxity on the PICC

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