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Status unknownNCT05629195PICCUpdated Nov 29, 2022

The Effect of Skin Laxity on the PICC

An interventional study of tunneled PICC in Complications; Catheter, sponsored by First People's Hospital of Foshan. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-11-29.

Sponsored by First People's Hospital of Foshan · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Nov 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
356
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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).

Read the 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

02

Conditions studied

  • Complications; Catheter
03

In context

Lead sponsor

First People's Hospital of Foshan is the lead sponsor of 10 studies on the registry; 3 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 ≥ 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 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

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 form.
Terms in these criteria, in plain language(2)

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.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

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.

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05

Study design

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

Study arms

  • Experimental
    tunneled PICC

    Placement of PICC catheter through tunnel technology

    Device: tunneled PICC

  • Active comparator
    conventional PICC

    Placement of PICC catheter through conventional technology

    Device: tunneled PICC

Interventions

  • Devicetunneled PICC

    PICC catheter is inserted into the superior vena cava through the upper brachial vein by establishing a subcutaneous tunnel

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 120 days

Secondary outcomes

  1. time of PICC insertion

    Time from the start of skin disinfection to the end of dressing fixation

    Time frame: 1 hour

  2. 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.

    Time frame: 1 hour

  3. 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

    Time frame: 1 hour

  4. rate of unplanned extubation

    Extubation after abnormal treatment

    Time frame: 120 days

  5. rate of difficulty in decannulation

    Probability of failure to pull out PICC due to vasospasm, adhesion with thrombus, wrapping of fibrin sheath, etc

    Time frame: 120 days

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 Nov 29, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05629195
Lead sponsor
First People's Hospital of Foshan
Responsible party
Yingshan Zheng (nurse, First People's Hospital of Foshan) — Principal investigator
First posted
Nov 29, 2022
Start date
Dec 1, 2022 (estimated)
Primary completion
Sep 1, 2023 (estimated)
Completion
Dec 30, 2023 (estimated)
Last update
Nov 29, 2022

Oversight

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

Not currently enrolling

This study is status unknown, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.

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