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Not yet recruitingNCT05870449PICCUpdated May 23, 2023

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

An interventional study of tunneled PICC and routine PICC in Cancer, Thrombus and Phlebitis, sponsored by Shandong Branden Med.Device Co.,Ltd. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-05-23.

Sponsored by Shandong Branden Med.Device Co.,Ltd · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jul 2024, 2 years 4 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
1,666
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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

02

Conditions studied

  • Cancer
  • Thrombus
  • Phlebitis
  • Infections
03

In context

Neoplasms

10,818 studies on the registry are indexed under Neoplasms; 2,324 are open to participants now.

This study's planned enrollment of 1,666 is above the median of 60 across 7,703 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

Shandong Branden Med.Device Co.,Ltd is the lead sponsor of 13 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 form.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
1,666 participants (estimated)

Study arms

  • Experimental
    trial group

    Device: tunneled PICC

  • Active comparator
    control group

    Device: routine PICC

Interventions

  • Devicetunneled PICC

    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

  • Deviceroutine PICC

    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.

06

What researchers measure

Primary outcomes

  1. rate of complications

    Time frame: 120 days after operation

Secondary outcomes

  1. time of catheter retention

    Time frame: 7, 30, 60, 90 and 120 days after operation

Other outcomes

  1. rate of unplanned extubation

    Time frame: 7, 30, 60, 90 and 120 days after operation

  2. Success rate of one-time catheterization

    Time frame: 7, 30, 60, 90 and 120 days after operation

  3. Operation time

    Time frame: Immediately after operation

  4. incidence of difficulty in pulling out the tube

    Time frame: 7, 30, 60, 90 and 120 days after operation

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 23, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05870449
Lead sponsor
Shandong Branden Med.Device Co.,Ltd
Collaborators
Hainan Cancer Hospital
Responsible party
Sponsor
First posted
May 23, 2023
Start date
Jul 1, 2023 (estimated)
Primary completion
Jul 1, 2024 (estimated)
Completion
Dec 31, 2024 (estimated)
Last update
May 23, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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