AntimicrobialNCT06455228
Long Peripheral Intravenous Catheter Insertion Site and Catheter-related Complications in Antimicrobial Therapy
A study testing insert catheter in people with Antimicrobial, run by Sir Run Run Shaw Hospital at 1 site in China.
Trial summary
This study applies long PIVCs to patients undergoing antimicrobial therapy, and compares the effects of different placement sites, aiming to provide a reference basis for patients undergoing antimicrobial treatment to select the optimal placement site, thus reducing complications, prolonging catheter retention time… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Antimicrobial
- What is being tested?
- insert catheter
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 30 May 2024to 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
- ① estimated time of intravenous infusion ≥1 week; ② age: ≥18 years; ③ antimicrobial therapy was only used for treatment during hospitalization, with a pH value of 5-9 and osmotic pressure \< 900 mOsm/L; and ④ patients were conscious and able to communicate normally; ⑤ the catheter-to-vessel ratio is less than 45%.
Who cannot join
- ① a history of radiotherapy, thrombosis, and trauma at the catheterization site and ② plans to discharge with a catheter during the study duration.
Trial locations and contacts
1 site in 1 country.
China1 site
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, 310016
About this study
Official title: Long Peripheral Intravenous Catheter Insertion Site and Catheter-related Complications in Antimicrobial Therapy: a Randomized Controlled Trial
This study applies long PIVCs to patients undergoing antimicrobial therapy, and compares the effects of different placement sites, aiming to provide a reference basis for patients undergoing antimicrobial treatment to select the optimal placement site, thus reducing complications, prolonging catheter retention time, and alleviating the patient's pain.
Read the detailed description
This study investigates the use of long PIVCs in patients undergoing antimicrobial therapy, and compares the effects of different insertion sites. The aim is to provide evidence-based recommendations for the optimal placement site for long PIVCs in antimicrobial treatment, with the goals of reducing complications, prolonging catheter retention time, and alleviating patient discomfort.
- Conditions
- Antimicrobial
- Being tested
- insert catheter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
insert catheterDevice
A fixed routine for pre-insertion cleaning and equipment was followed, including hand washing, placing the patient in a recumbent position, skin antisepsis, and preparation of the sterile field. Catheter insertion was performed by senior specialized nurses in the intravenous treatment room, which was a standardized setting for venipuncture.
| Study group | Role | What they receive |
|---|---|---|
| upper arm | Experimental | ①Evaluation: The puncture site was determined by senior nurses based on group assignment before placement. The depth and diameter of the pre-punctured vein were measured using ultrasound assessment, and the intima of the pre-punctured vein was examined without applying a tourniquet. ②Catheterization: A 3 Fr, 8 cm tip-opened long PIVC was used. Catheters were placed according to the designated sites for each group using ultrasound-guided and accelerated Seidinger techniques. After confirming catheter placement, needleless connectors and extension were attached, and the catheter was secured without tension using a sterile transparent dressing. ③Maintenance: Specialized nurses were trained to monitor and evaluate catheter function daily. Clinical nurses conducted routine maintenance until the study completion. Daily data were recorded and updated in computerized records. Receives: Device: insert catheter |
| forearm | Other | ①Evaluation: The puncture site was determined by senior nurses based on group assignment before placement. The depth and diameter of the pre-punctured vein were measured using ultrasound assessment, and the intima of the pre-punctured vein was examined without applying a tourniquet. ②Catheterization: A 3 Fr, 8 cm tip-opened long PIVC was used. Catheters were placed according to the designated sites for each group using ultrasound-guided and accelerated Seidinger techniques. After confirming catheter placement, needleless connectors and extension were attached, and the catheter was secured without tension using a sterile transparent dressing. ③Maintenance: Specialized nurses were trained to monitor and evaluate catheter function daily. Clinical nurses conducted routine maintenance until the study completion. Daily data were recorded and updated in computerized records. Receives: Device: insert catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of catheter-related complications
Catheter-related complications were assessed including thrombophlebitis, other phlebitis, catheter occlusion, bleeding, catheter-related infections, and weeping.
Measured: After insertion of catheter
Secondary outcomes (3)
Puncture success rate with one-attempt
The puncture success rate with one-attempt refers to the instance where the puncture needle successfully enters the target vein on the first attempt without needing to change the puncture site.
Measured: After insertion of catheter
The procedure time
The procedure time is defined as the duration from the start of skin disinfection to the stabilization of the catheter with dressing.
Measured: After insertion of catheter.
Indwelling catheter duration
The Indwelling catheter duration refers to the number of days between the date of catheter placement and its removal.
Measured: After insertion of catheter
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2024
- Study start30 May 2024
- Primary completion25 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AntimicrobialStudies of the same condition, open and under way.
- More trials run by Sir Run Run Shaw HospitalThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sir Run Run Shaw Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhao Linfang, Principal investigator, Sir Run Run Shaw Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06455228
- Sponsor's protocol ID
- 2024-2233-01
- Status last verified
- Nov 2024
- First submitted
- 30 May 2024
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhao L, Jin X, Li X, Liu C, Wang J, Cao X, Zeng X, Zhuang Y. Differences in catheter-related complications to insertion site selection for long peripheral intravenous catheters in antimicrobial therapy: a randomized controlled trial. BMC Nurs. 2025 Feb 4;24(1):131. doi: 10.1186/s12912-025-02749-y.
PubMed 39905387
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Peripheral Intravenous Catheter Insertion Site and Catheter-related Complications in Antimicrobial Therapy: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06455228
- Acronym / sponsor ID
- 2024-2233-01
- Conditions
- Antimicrobial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Sir Run Run Shaw HospitalUniversity, hospital or other
- Study start
- 30 May 2024 (actual)
- Primary completion
- 25 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 12 Jun 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.
This study applies long PIVCs to patients undergoing antimicrobial therapy, and compares the effects of different placement sites, aiming to provide a reference basis for patients undergoing antimicrobial treatment to select the optimal placement site, thus reducing complications, prolonging catheter retention time, and alleviating the patient's pain.
Detailed description
This study investigates the use of long PIVCs in patients undergoing antimicrobial therapy, and compares the effects of different insertion sites. The aim is to provide evidence-based recommendations for the optimal placement site for long PIVCs in antimicrobial treatment, with the goals of reducing complications, prolonging catheter retention time, and alleviating patient discomfort.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| upper arm | Experimental | Device: insert catheter①Evaluation: The puncture site was determined by senior nurses based on group assignment before placement. The depth and diameter of the pre-punctured vein were measured using ultrasound assessment, and the intima of the pre-punctured vein was examined without applying a tourniquet. ②Catheterization: A 3 Fr, 8 cm tip-opened long PIVC was used. Catheters were placed according to the designated sites for each group using ultrasound-guided and accelerated Seidinger techniques. After confirming catheter placement, needleless connectors and extension were attached, and the catheter was secured without tension using a sterile transparent dressing. ③Maintenance: Specialized nurses were trained to monitor and evaluate catheter function daily. Clinical nurses conducted routine maintenance until the study completion. Daily data were recorded and updated in computerized records. |
| forearm | Other | Device: insert catheter①Evaluation: The puncture site was determined by senior nurses based on group assignment before placement. The depth and diameter of the pre-punctured vein were measured using ultrasound assessment, and the intima of the pre-punctured vein was examined without applying a tourniquet. ②Catheterization: A 3 Fr, 8 cm tip-opened long PIVC was used. Catheters were placed according to the designated sites for each group using ultrasound-guided and accelerated Seidinger techniques. After confirming catheter placement, needleless connectors and extension were attached, and the catheter was secured without tension using a sterile transparent dressing. ③Maintenance: Specialized nurses were trained to monitor and evaluate catheter function daily. Clinical nurses conducted routine maintenance until the study completion. Daily data were recorded and updated in computerized records. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ① estimated time of intravenous infusion ≥1 week; ② age: ≥18 years; ③ antimicrobial therapy was only used for treatment during hospitalization, with a pH value of 5-9 and osmotic pressure \< 900 mOsm/L; and ④ patients were conscious and able to communicate normally; ⑤ the catheter-to-vessel ratio is less than 45%.
Key exclusion criteria (1 listed)
- ① a history of radiotherapy, thrombosis, and trauma at the catheterization site and ② plans to discharge with a catheter during the study duration.
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 |
|---|---|---|
| insert catheterA fixed routine for pre-insertion cleaning and equipment was followed, including hand washing, placing the patient in a recumbent position, skin antisepsis, and preparation of the sterile field. Catheter insertion was performed by senior specialized nurses in the intravenous treatment room, which was a standardized setting for venipuncture. | Device | forearm, upper arm |
Primary outcome
Incidence of catheter-related complications
Time frame: After insertion of catheter
Catheter-related complications were assessed including thrombophlebitis, other phlebitis, catheter occlusion, bleeding, catheter-related infections, and weeping.
3 secondary outcomes
Puncture success rate with one-attempt
Time frame: After insertion of catheter
The procedure time
Time frame: After insertion of catheter.
Indwelling catheter duration
Time frame: After insertion of catheter
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Derived from this study: PubMed 39905387Zhao L, Jin X, Li X, Liu C, Wang J, Cao X, Zeng X, Zhuang Y. Differences in catheter-related complications to insertion site selection for long peripheral intravenous catheters in antimicrobial therapy: a randomized controlled trial. BMC Nurs. 2025 Feb 4;24(1):131. doi: 10.1186/s12912-025-02749-y.
- 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.
Zhao Linfang principal investigator
Sir Run Run Shaw 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 insert catheter in people with Antimicrobial, run by Sir Run Run Shaw 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 29 Apr 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of catheter-related complications (time frame: After insertion of catheter). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06455228, which also lists 1 linked publication.
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 29 Apr 2026.