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

May 22, 2023 updated by: Shandong Branden Med.Device Co.,Ltd

The Impact of Climate Environment in Different Latitudes on the Occurrence of PICC Complications and Intervention Measures - Prospective, Multicenter, Randomized Controlled Study

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

1666

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: control group
Device: routine 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.
Experimental: trial group
Device: tunneled 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
rate of complications
Time Frame: 120 days after operation
120 days after operation

Secondary Outcome Measures

Outcome Measure
Time Frame
time of catheter retention
Time Frame: 7, 30, 60, 90 and 120 days after operation
7, 30, 60, 90 and 120 days after operation

Other Outcome Measures

Outcome Measure
Time Frame
rate of unplanned extubation
Time Frame: 7, 30, 60, 90 and 120 days after operation
7, 30, 60, 90 and 120 days after operation
Success rate of one-time catheterization
Time Frame: 7, 30, 60, 90 and 120 days after operation
7, 30, 60, 90 and 120 days after operation
Operation time
Time Frame: Immediately after operation
Immediately after operation
incidence of difficulty in pulling out the tube
Time Frame: 7, 30, 60, 90 and 120 days after operation
7, 30, 60, 90 and 120 days after operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shandong Branden Med.Device Co.,Ltd

Collaborators

Hainan Cancer Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 1, 2023

Primary Completion (Anticipated)

July 1, 2024

Study Completion (Anticipated)

December 31, 2024

Study Registration Dates

First Submitted

May 6, 2023

First Submitted That Met QC Criteria

May 22, 2023

First Posted (Actual)

May 23, 2023

Study Record Updates

Last Update Posted (Actual)

May 23, 2023

Last Update Submitted That Met QC Criteria

May 22, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • hainan-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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