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NCT03723187 Clinical Trial

Study of Standard Maintenance Method of Intravenous Port and Post-operation Pain Analysis

Cancer Clinical Trial

Official title:
Study of Standard Maintenance Method of Intravenous Port and Post-operation Pain Analysis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03723187
Other study ID # CGMH-IRB-104-9029B
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 1, 2016
Est. completion date July 31, 2019

Study information
Verified date July 2019
Source Chang Gung Memorial Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Investigators deconstructed the port that removed from patients and identified there were structural weakness, old blood clot and fibrin deposits. Investigators consider the problem may be exist in maintenance. After thoroughly examination the maintenance protocol, Investigators identified the problem and try to remodel the maintenance protocol. The Goal of this study was to testify the clinical value of standard maintenance protocol.

Description:

A secure and easily feasible vascular access is crucial for oncology patients because of the therapeutic need. Although intravenous port has been utilized for 3 decades, catheter-related complication still remain and had to deal with. According to investigators clinical experience, investigators summarized a standard algorithm as a recommendation for intravenous sport implantation. The complication before and after standard algorithm was 20 % and 3.5 %, respectively. However, catheter related infection and malfunction still could not be avoided. If patient was identified with these 2 complications, re-intervention is needed and cancer-related therapy has to be postpone. Investigators deconstructed the port that removed from patients and identified there were structural weakness, old blood clot and fibrin deposits. Investigators consider the problem may be exist in maintenance. After thoroughly examination the maintenance protocol, investigators identified the problem and try to remodel the maintenance protocol. The Goal of this study was to testify the clinical value of standard maintenance protocol.

Recruitment information / eligibility
Status Completed
Enrollment 38
Est. completion date July 31, 2019
Est. primary completion date July 31, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: - Volunteer with new Port-A inserted Exclusion Criteria: - No

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• normal saline
experimental group use normal saline sealing tube
• normal saline+heparin
normal saline+heparin(Currently, Regular used in hospital)

Locations
Country Name City State
Taiwan Chang Gung Memorial Hospital Taoyuan

Sponsors (1)
Lead Sponsor Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Port- A Catheter complication In the case of catheter-related complications, a complete biochemical and blood test will be performed on the patient.
Will be tested for possible clotting factors, inflammatory index including CRP; procalcitonin; CBC / DC; PT / aPTT /Protein C/ protein S		 1 year
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