NCT06503822

Brief Summary

Short PIVC (intravenous indentation needle) accounts for more than 50% of clinical infusion tools, but long PIVC is rarely used and studied in China. This study aims to explore the application characteristics and application effects of long PIVC in China. It provides reference for the correct selection of infusion tools, and promotes the clinical application and promotion of new intravenous therapy tools. The study nurse will work with the responsible physician to assess the eligibility for enrollment and sign the informed consent. Were randomly assigned to the control group (to receive a new 24G/22G (0.7mm\*19mm/0.9mm\*25mm) short PIVC (closed needle protected venous catheter system) puncture) or the intervention group (to insert a new 3F (8cm) or 4F(10cm) long PIVC) for daily routine maintenance until catheter removal, General demographic data, laboratory-related data, catheter-related data, catheter-related complications (unplanned extubation, phlebitis, catheter blockage, catheter-related thrombosis, catheter-related bloodstream infection, exudation, etc.) and patient satisfaction were collected.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2023

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 5, 2023

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 27, 2024

Completed
19 days until next milestone

First Posted

Study publicly available on registry

July 16, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

July 16, 2024

Status Verified

June 1, 2024

Enrollment Period

9 months

First QC Date

June 27, 2024

Last Update Submit

July 14, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Unplanned extubation

    Any complications of catheter removal before completion of IV therapy or before the recommended time of catheter use. Removal of the catheter at the end of intravenous infusion therapy is not considered catheter failure.

    Up to 2 months

Study Arms (2)

Intervention group

EXPERIMENTAL

In the intervention group, a new long peripheral venous catheter was selected by the puncture operator according to the puncture location and venous conditions, and was placed using aseptic technology. After blood return, the catheter could be easily rinsed with 0.9% sodium chloride solution, which was considered to be placed in the correct position and could be used normally. Intravenous infusion therapy begins immediately after successful catheterization. Check the condition of the catheter at least 3 times a day, and rinse with 10 ml.9% sodium chloride solution before each intravenous treatment; After disconnection of any infusion, pulse flushing with 0.9% sodium chloride solution 10ml and positive pressure sealing tube flushing to seal the catheter. Collect patient information, including sociodemographic information, duration of intravenous therapy, and details about catheter failure.

Device: Long peripheral venous catheter

Control group

ACTIVE COMPARATOR

The control group will receive a new 24G or 22G short peripheral venous catheter with direct view aseptic technique puncture, see blood return and rinse easily with 0.9% sodium chloride solution. The catheter is considered to be in the correct position and can be used normally. Check the condition of the catheter at least 3 times a day, and rinse with 10 ml.9% sodium chloride solution before each intravenous treatment; After disconnection of any infusion, pulse flushing with 0.9% sodium chloride solution 10ml and positive pressure sealing tube flushing to seal the catheter. Collect patient information, including sociodemographic information, duration of intravenous therapy, and details about catheter failure.

Other: Control group (Short peripheral venous catheter)

Interventions

In this study, patients eligible for admission were subjected to peripheral vein long catheter puncture according to the operating standards, daily routine maintenance until catheter removal, and relevant data were collected.

Intervention group

In this study, the patients eligible for admission will undergo peripheral venous short catheter puncture according to the operating standards, daily routine maintenance until catheter removal, and relevant data will be collected.

Also known as: Short peripheral venous catheter
Control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • A male or female aged 18 years or older who is able and willing to give written informed consent;
  • Identification of the patient's medical diagnosis based on the competent physician and the study nurse at any time during the hospital stay, and judgment that the duration of peripheral intravenous infusion therapy needs to exceed 4 days;
  • Subjects with good compliance and can cooperate with catheter maintenance and observation.

You may not qualify if:

  • Patients who are delirious and unable to cooperate;
  • Patients requiring central venous access;
  • Patients suffering from connective tissue diseases or blood diseases;
  • Patients allergic to catheters or dressings;
  • any subject in a condition deemed by the investigator to interfere with the evaluation of results or pose a health risk to the subject.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Deng Qiuxia

Shenzhen, Guangdong, China

RECRUITING

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Xiaoning Liu

    Shenzhen Third People's Hospital

    STUDY CHAIR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2024

First Posted

July 16, 2024

Study Start

December 5, 2023

Primary Completion

August 31, 2024

Study Completion

December 31, 2024

Last Updated

July 16, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations