- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06014099
Research on the Application of Blood Collection Through Midline Catheters of Different Lengths
October 24, 2023 updated by: Zhao Linfang, Sir Run Run Shaw Hospital
Therefore, in this study, the investigators propose to use a randomized controlled prospective open study on inpatients with difficult blood collection, by comparing the effects of the application of two types of peripheral venous catheters for blood collection via LPC and MC, with a view to improving the success rate of blood collection in difficult peripheral venous blood collection, and providing a theoretical basis for the later application of long peripheral venous catheters and midline catheters; and providing a basis for optimizing the experience of venous blood collection by nurses.
Study Overview
Status
Not yet recruiting
Conditions
Detailed Description
Using block randomization, patients were randomized in 1:1:1 blocks into experimental arm 1(Long peripheral venous catheter), experimental arm 2(midline catheter), and control (short peripheral venous catheter) with a block length of 6. Patients have a total of 27 blocks, import data into SPSS23, randomly group by SPSS, generate random numbers, and group according to the size of random numbers in each unit group, the largest in the group is assigned to the experimental group 1, the middle of the group is assigned to the experimental group 2, and the smallest in the group is assigned to the control group.
The experimental group1 used the LPC for blood collection, the experimental group 2 used the MC for blood collection,and the control group used the Short PIVC for blood collection.
Study Type
Interventional
Enrollment (Estimated)
162
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Linfang Zhao
- Phone Number: 13588819123
- Email: 3193159@zju.edu.cn
Study Contact Backup
- Name: Xiuzhu Cao
- Phone Number: 13588477316
- Email: Caoxz@srrsh.com
Study Locations
-
-
Zhejiang
-
Hangzhou, Zhejiang, China, 310000
- Linfang Zhao
-
Contact:
- Linfang Zhao
- Phone Number: 13588819123
- Email: 3193159@zju.edu.cn
-
Contact:
- Xiuzhu Cao
- Phone Number: 13588477316
- Email: Caoxz@srrsh.com
-
-
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
Yes
Description
Inclusion Criteria:
- Meet the international diagnostic criteria for metabolic syndrome (such as ATP III criteria or domestic Diabetes Branch of Chinese Medical Association criteria).
- The estimated treatment time of intravenous infusion is 1-4 weeks, and the nature of the infusion drug meets the indications of LPCs and MCs.
- Blood samples should be collected more than 3 times during the hospital.
Exclusion Criteria:
- A history of radiotherapy, thrombosis, and trauma at the catheter site.
- Plan to discharge from the hospital with the tube.
- Vulnerable groups, including people with mental illness, cognitive impairment, critically ill patients, minors, pregnant women, illiterate, etc.
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: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Midline catheter
The test group2 used MC for blood collection.
|
used MCs for blood collection
|
Experimental: Long peripheral venous catheters
In the test 1 group, blood was collected using LPC.
|
used LPC for blood collection
|
Other: short peripheral venous catheters
In the control group,blood was collected using SPC.
|
used SPCs for blood collection
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Success rate of first blood collection
Time Frame: during catheter indwelling,an average of 2 weeks
|
Number of successful initial venous blood collection cases as a percentage of the total number of cases in this group
|
during catheter indwelling,an average of 2 weeks
|
Total success rate of blood collection
Time Frame: during catheter indwelling,an average of 2 weeks
|
Number of patients with successful intravenous blood collection as a proportion of the number of cases in this group
|
during catheter indwelling,an average of 2 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Catheter-related complication rate
Time Frame: during catheter indwelling,an average of 2 weeks
|
The proportion of patients with complications as a proportion of the total number of cases
|
during catheter indwelling,an average of 2 weeks
|
Number of days for catheters to linger
Time Frame: during catheter indwelling,an average of 2 weeks
|
The number of days between catheter insertion and catheter removal
|
during catheter indwelling,an average of 2 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Linfang Zhao, Sir Run Run Shaw Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Gorski LA, Hadaway L, Hagle ME, Broadhurst D, Clare S, Kleidon T, Meyer BM, Nickel B, Rowley S, Sharpe E, Alexander M. Infusion Therapy Standards of Practice, 8th Edition. J Infus Nurs. 2021 Jan-Feb 01;44(1S Suppl 1):S1-S224. doi: 10.1097/NAN.0000000000000396. No abstract available.
- Lima-Oliveira G, Lippi G, Salvagno GL, Picheth G, Guidi GC. Laboratory Diagnostics and Quality of Blood Collection. J Med Biochem. 2015 Jul;34(3):288-294. doi: 10.2478/jomb-2014-0043. Epub 2015 Jul 14.
- HO Guidelines Approved by the Guidelines Review Committee[J]. 2015.
- Tsukuda Y, Funakoshi T, Nasuhara Y, Nagano Y, Shimizu C, Iwasaki N. Venipuncture Nerve Injuries in the Upper Extremity From More Than 1 Million Procedures. J Patient Saf. 2019 Dec;15(4):299-301. doi: 10.1097/PTS.0000000000000264.
- Jeong Y, Park H, Jung MJ, Kim MS, Byun S, Choi Y. Comparisons of laboratory results between two blood samplings: Venipuncture versus peripheral venous catheter-A systematic review with meta-analysis. J Clin Nurs. 2019 Oct;28(19-20):3416-3429. doi: 10.1111/jocn.14918. Epub 2019 Jun 10.
- Wicker S, Stirn AV, Rabenau HF, von Gierke L, Wutzler S, Stephan C. Needlestick injuries: causes, preventability and psychological impact. Infection. 2014 Jun;42(3):549-52. doi: 10.1007/s15010-014-0598-0. Epub 2014 Feb 14.
- Zhang Y, Zhang S, Chen J, Zhao R. Blood sampling from peripherally inserted central catheter is effective and safe for patients with head and neck cancers. J Vasc Access. 2021 May;22(3):424-431. doi: 10.1177/1129729820943458. Epub 2020 Aug 3.
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 (Estimated)
October 27, 2023
Primary Completion (Estimated)
December 30, 2025
Study Completion (Estimated)
December 30, 2025
Study Registration Dates
First Submitted
March 13, 2023
First Submitted That Met QC Criteria
August 25, 2023
First Posted (Actual)
August 28, 2023
Study Record Updates
Last Update Posted (Actual)
October 25, 2023
Last Update Submitted That Met QC Criteria
October 24, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- IV202308
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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