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

Sponsor
Shandong Branden Med.Device Co.,Ltd (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05870449
Collaborator
Hainan Cancer Hospital (Other)
1,666
2
18

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Device: tunneled PICC
  • Device: routine PICC
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
1666 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
The Impact of Climate Environment in Different Latitudes on the Occurrence of PICC Complications and Intervention Measures - Prospective, Multicenter, Randomized Controlled Study
Anticipated Study Start Date :
Jul 1, 2023
Anticipated Primary Completion Date :
Jul 1, 2024
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

Arm Intervention/Treatment
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

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.

Outcome Measures

Primary Outcome Measures

  1. rate of complications [120 days after operation]

Secondary Outcome Measures

  1. time of catheter retention [7, 30, 60, 90 and 120 days after operation]

Other Outcome Measures

  1. rate of unplanned extubation [7, 30, 60, 90 and 120 days after operation]

  2. Success rate of one-time catheterization [7, 30, 60, 90 and 120 days after operation]

  3. Operation time [Immediately after operation]

  4. incidence of difficulty in pulling out the tube [7, 30, 60, 90 and 120 days after operation]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Shandong Branden Med.Device Co.,Ltd
  • Hainan Cancer Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Shandong Branden Med.Device Co.,Ltd
ClinicalTrials.gov Identifier:
NCT05870449
Other Study ID Numbers:
  • hainan-01
First Posted:
May 23, 2023
Last Update Posted:
May 23, 2023
Last Verified:
May 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 23, 2023