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The Impact of Climate Environment in Different Latitudes on the Occurrence of PICC Complications (PICC)

Primary Purpose

Cancer, Thrombus, Phlebitis

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
tunneled PICC
routine PICC
Sponsored by
Shandong Branden Med.Device Co.,Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cancer

Eligibility Criteria

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

Inclusion Criteria: Patients aged ≥ 18 years old; Patients who follow medical advice and require PICC 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; There are no serious cardiovascular diseases, such as atrial fibrillation, pulmonary heart disease, and other P-wave abnormalities before catheterization, as well as severe heart conduction block Exclusion Criteria: Known allergies to catheter materials; There is a history of infection, injury, and radiation therapy at the puncture site; The puncture site has a history of venous thrombosis or surgery; Severe abnormal coagulation function; Superior vena cava compression syndrome; Surgical side limbs of breast cancer patients undergoing radical mastectomy or axillary lymph node dissection; Heart pacemaker and arteriovenous fistula on the same side of the limb; Patients or patients' 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

    trial group

    control group

    Arm Description

    Outcomes

    Primary Outcome Measures

    rate of complications

    Secondary Outcome Measures

    time of catheter retention

    Full Information

    First Posted
    May 6, 2023
    Last Updated
    May 22, 2023
    Sponsor
    Shandong Branden Med.Device Co.,Ltd
    Collaborators
    Hainan Cancer Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05870449
    Brief Title
    The Impact of Climate Environment in Different Latitudes on the Occurrence of PICC Complications
    Acronym
    PICC
    Official Title
    The Impact of Climate Environment in Different Latitudes on the Occurrence of PICC Complications and Intervention Measures - Prospective, Multicenter, Randomized Controlled Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 1, 2023 (Anticipated)
    Primary Completion Date
    July 1, 2024 (Anticipated)
    Study Completion Date
    December 31, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Shandong Branden Med.Device Co.,Ltd
    Collaborators
    Hainan Cancer Hospital

    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
    In this study, eligible subjects were randomly assigned to the experimental or control group through randomization (1:1). Under the guidance of electrocardiographic Doppler ultrasound guided puncture and catheterization (EDUG) technology, the tunnel puncture method was compared with the conventional puncture method. The two groups of patients were observed and evaluated intraoperative and postoperative 7 ± 3 days, 30 ± 7 days, 60 ± 10 days, and 90 ± 10 days 120 ± 10 days (if any) and the occurrence of complications during extubation or unplanned extubation at the end of treatment, comparing cases in the north and south, as well as complications related to different catheterization methods

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cancer, Thrombus, Phlebitis, Infections

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    1666 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    trial group
    Arm Type
    Experimental
    Arm Title
    control group
    Arm Type
    Active Comparator
    Intervention Type
    Device
    Intervention Name(s)
    tunneled PICC
    Intervention Description
    Tunneled PICC is a type of PICC catheterization technique that involves establishing a subcutaneous tunnel to keep the outlet of the catheter away from the puncture site
    Intervention Type
    Device
    Intervention Name(s)
    routine PICC
    Intervention Description
    Peripherally inserted central venous catheterization is a technique that involves inserting PICC through the peripheral vein and infusing drugs into the central vein through a catheter.
    Primary Outcome Measure Information:
    Title
    rate of complications
    Time Frame
    120 days after operation
    Secondary Outcome Measure Information:
    Title
    time of catheter retention
    Time Frame
    7, 30, 60, 90 and 120 days after operation
    Other Pre-specified Outcome Measures:
    Title
    rate of unplanned extubation
    Time Frame
    7, 30, 60, 90 and 120 days after operation
    Title
    Success rate of one-time catheterization
    Time Frame
    7, 30, 60, 90 and 120 days after operation
    Title
    Operation time
    Time Frame
    Immediately after operation
    Title
    incidence of difficulty in pulling out the tube
    Time Frame
    7, 30, 60, 90 and 120 days after operation

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients aged ≥ 18 years old; Patients who follow medical advice and require PICC 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; There are no serious cardiovascular diseases, such as atrial fibrillation, pulmonary heart disease, and other P-wave abnormalities before catheterization, as well as severe heart conduction block Exclusion Criteria: Known allergies to catheter materials; There is a history of infection, injury, and radiation therapy at the puncture site; The puncture site has a history of venous thrombosis or surgery; Severe abnormal coagulation function; Superior vena cava compression syndrome; Surgical side limbs of breast cancer patients undergoing radical mastectomy or axillary lymph node dissection; Heart pacemaker and arteriovenous fistula on the same side of the limb; Patients or patients' family members refuse to sign the informed consent form.

    12. IPD Sharing Statement

    Learn more about this trial

    The Impact of Climate Environment in Different Latitudes on the Occurrence of PICC Complications

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