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Trial Title:
The Impact of Climate Environment in Different Latitudes on the Occurrence of PICC Complications
NCT ID:
NCT05870449
Condition:
Cancer
Thrombus
Phlebitis
Infections
Conditions: Official terms:
Phlebitis
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Single (Outcomes Assessor)
Intervention:
Intervention type:
Device
Intervention name:
tunneled PICC
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
Arm group label:
trial group
Intervention type:
Device
Intervention name:
routine PICC
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.
Arm group label:
control group
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
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
July 1, 2023
Completion date:
December 31, 2024
Lead sponsor:
Agency:
Shandong Branden Med.Device Co.,Ltd
Agency class:
Industry
Collaborator:
Agency:
Hainan Cancer Hospital
Agency class:
Other
Source:
Shandong Branden Med.Device Co.,Ltd
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05870449