Hospitalized PatientsNCT06503822
Comparison of Application Effects Between Long- and Standard Short- Peripheral Venous Catheters
A study testing Long peripheral venous catheter in people with Hospitalized Patients, run by Shenzhen Third People's Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hospitalized Patients
- What is being tested?
- Long peripheral venous catheter
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteChina
- Study dates
- 5 Dec 2023to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Deng Qiuxia
Shenzhen, Guangdong
Qiuxia Deng, +86 0755-61222333 ext. 13250, 83762312@qq.com
About this study
Official title: Comparison of Application Effects Between Long Peripheral Venous Catheters and Standard Short Peripheral Venous Catheters: A Multicenter Prospective Randomized Controlled Trial Study
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.
Read the detailed description
The control group will receive a new 24G or 22G short peripheral venous catheter for puncture using direct view aseptic technique, while the intervention group will be implanted with a new long peripheral venous catheter selected by the puncture operator using aseptic technique depending on the puncture location and venous conditions. After successful puncture, blood was returned in both groups and easily washed with 0.9% sodium chloride solution. The catheter was considered to be placed in the correct position and could be used normally. Intravenous infusion therapy should be started immediately after successful catheterization. The catheter should be checked at least 3 times a day and washed with 10 ml.9% sodium chloride solution before each intravenous therapy. After disconnection of any infusion, pulse flushing with 0.9% sodium chloride solution 10ml and positive pressure sealing tube flushing to seal the catheter. Patient information was collected during the study, including sociodemographic information, duration of intravenous therapy, and details about catheter failure.
- Conditions
- Hospitalized Patients
- Being tested
- Long peripheral venous catheter, Control group (Short peripheral venous catheter)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Long peripheral venous catheterDevice
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.
Control group (Short peripheral venous catheter)Other
Also called Short peripheral venous catheter
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Control group (Short peripheral venous catheter) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2024
- Study start5 Dec 2023
- Primary completion31 Aug 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hospitalized PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen Third People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiaoning Liu, Study chair, Shenzhen Third People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06503822
- Sponsor's protocol ID
- 2023-089-02
- Status last verified
- Jun 2024
- First submitted
- 27 Jun 2024
- Last updated
- 16 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Application Effects Between Long Peripheral Venous Catheters and Standard Short Peripheral Venous Catheters: A Multicenter Prospective Randomized Controlled Trial Study
- ClinicalTrials.gov ID
- NCT06503822
- Acronym / sponsor ID
- 2023-089-02
- Conditions
- Hospitalized Patients
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Shenzhen Third People's HospitalUniversity, hospital or other
- Study start
- 5 Dec 2023 (actual)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 16 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The control group will receive a new 24G or 22G short peripheral venous catheter for puncture using direct view aseptic technique, while the intervention group will be implanted with a new long peripheral venous catheter selected by the puncture operator using aseptic technique depending on the puncture location and venous conditions. After successful puncture, blood was returned in both groups and easily washed with 0.9% sodium chloride solution. The catheter was considered to be placed in the correct position and could be used normally. Intravenous infusion therapy should be started immediately after successful catheterization. The catheter should be checked at least 3 times a day and washed with 10 ml.9% sodium chloride solution before each intravenous therapy. After disconnection of any infusion, pulse flushing with 0.9% sodium chloride solution 10ml and positive pressure sealing tube flushing to seal the catheter. Patient information was collected during the study, including sociodemographic information, duration of intravenous therapy, and details about catheter failure.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Device: Long peripheral venous catheterIn 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. |
| Control group | Active comparator | Other: Control group (Short peripheral venous catheter)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Long peripheral venous catheterIn 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. | Device | Intervention group |
| Control group (Short peripheral venous catheter)Also: Short peripheral venous catheterIn 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. | Other | Control group |
Primary outcome
Unplanned extubation
Time frame: Up to 2 months
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiaoning Liu study chair
Shenzhen Third People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Long peripheral venous catheter in people with Hospitalized Patients, run by Shenzhen Third People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qiuxia Deng (+86 0755-61222333 ext. 13250, 83762312@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Unplanned extubation (time frame: Up to 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2024.