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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06014099
Other study ID # IV202308
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date October 27, 2023
Est. completion date December 30, 2025

Study information

Verified date October 2023
Source Sir Run Run Shaw Hospital
Contact Linfang Zhao
Phone 13588819123
Email 3193159@zju.edu.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 162
Est. completion date December 30, 2025
Est. primary completion date December 30, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Long peripheral venous catheters for blood collection
used LPC for blood collection
Midline catheter for blood collection
used MCs for blood collection
SPCs for blood collection
used SPCs for blood collection

Locations

Country Name City State
China Linfang Zhao Hangzhou Zhejiang

Sponsors (1)

Lead Sponsor Collaborator
Sir Run Run Shaw Hospital

Country where clinical trial is conducted

China, 

References & Publications (7)

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. — View Citation

HO Guidelines Approved by the Guidelines Review Committee[J]. 2015.

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Success rate of first blood collection 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
Primary Total success rate of blood collection 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 Catheter-related complication rate The proportion of patients with complications as a proportion of the total number of cases during catheter indwelling,an average of 2 weeks
Secondary Number of days for catheters to linger The number of days between catheter insertion and catheter removal during catheter indwelling,an average of 2 weeks
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