Short Peripheral Venous CatheterSPECIALNCT03290573
Site Selection of Short Peripheral Venous Catheters
A study testing short peripheral venous catheter in people with Short Peripheral Venous Catheter, run by The First Affiliated Hospital of Zhengzhou University at 6 sites in China.
Trial summary
Up to 90% of catheters fail before therapy is complete. Improved dwell time of intravenous catheters for even small increments of time would further reduce the number of insertions, staff workloads, and costs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Short Peripheral Venous Catheter
- What is being tested?
- short 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
- 1,517 participants
- Where
- 6 sitesChina
- Study dates
- 29 Sep 2017to 6 Jan 2019
- 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
- Age >18 years
- Expected duration of infusion therapy by short peripheral intravenous catheters >7 days
- Give written informed consent
Who cannot join
- The peripheral venous catheter was inserted in emergency room or in emergency circumstances
- Bloodstream infection
- Had a peripheral venous catheter already in situ at the baseline
- Altered mental state
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
China6 sites
Xuanwu Hospital Captial Medical University
Beijing, Beijing Municipality
Guizhou Provincial People's Hospital
Guiyang, Guizhou
Suzhou municipal hospital
Suzhou, Anhui
Xiangtan Central Hospital
Xiangtan, Hunan
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450000
The Fifth Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan
About this study
Official title: Site Selection of Peripheral Venous Access Via Short Peripheral Catheters in Adult Patients (SPECIAL Trial)
Up to 90% of catheters fail before therapy is complete. Improved dwell time of intravenous catheters for even small increments of time would further reduce the number of insertions, staff workloads, and costs. In this study, the investigators investigated whether short peripheral venous catheter site of insertion influence the dwell time.
- Conditions
- Short Peripheral Venous Catheter
- Being tested
- short peripheral venous catheter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
short peripheral venous catheterDevice
short peripheral venous catheter for infusion therapy in adult patients
| Study group | Role | What they receive |
|---|---|---|
| Dorsum of hand group | Active comparator | short peripheral venous catheter place in the dorsum of the hand Receives: Device: short peripheral venous catheter |
| Forearm group | Experimental | short peripheral venous catheter place in the forearm Receives: Device: short peripheral venous catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Indwelling time
Measured: from the cannulae insertion until its removal, usually within 2 weeks
Secondary outcomes (6)
Phlebitis
Measured: from the cannulae insertion until its removal, usually within 2 weeks
Occlusion of the catheter
Measured: from the cannulae insertion until its removal, usually within 2 weeks
Infiltration
Measured: from the cannulae insertion until its removal, usually within 2 weeks
Accidental catheter removal
Measured: from the cannulae insertion until its removal, usually within 2 weeks
Local venous infection
Measured: from the cannulae insertion until its removal, usually within 2 weeks
Catheter-related bloodstream infection
Measured: from the cannulae insertion until its removal, usually within 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2017
- Study start29 Sep 2017
- Primary completion26 Dec 2018
- Study completion6 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Short Peripheral Venous CatheterStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Zhengzhou UniversityThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,517 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chuanjie Wu, The First Affiliated Hospital of Zhengzhou University
- Investigators
- Chuanjie Wu, MD, Study chair, The First Affiliated Hospital of Zhengzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03290573
- Sponsor's protocol ID
- FAHZU-2017-016
- Acronym
- SPECIAL
- Status last verified
- Jan 2019
- First submitted
- 17 Sep 2017
- Last updated
- 8 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Site Selection of Peripheral Venous Access Via Short Peripheral Catheters in Adult Patients (SPECIAL Trial)
- ClinicalTrials.gov ID
- NCT03290573
- Acronym / sponsor ID
- SPECIAL / FAHZU-2017-016
- Conditions
- Short Peripheral Venous Catheter
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,517 participants (actual)
- Lead sponsor
- The First Affiliated Hospital of Zhengzhou UniversityUniversity, hospital or other
- Study start
- 29 Sep 2017 (actual)
- Primary completion
- 26 Dec 2018 (actual)
- Study completion
- 6 Jan 2019 (actual)
- First posted
- 25 Sep 2017 (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.
Up to 90% of catheters fail before therapy is complete. Improved dwell time of intravenous catheters for even small increments of time would further reduce the number of insertions, staff workloads, and costs. In this study, the investigators investigated whether short peripheral venous catheter site of insertion influence the dwell time.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dorsum of hand group | Active comparator | Device: short peripheral venous cathetershort peripheral venous catheter place in the dorsum of the hand |
| Forearm group | Experimental | Device: short peripheral venous cathetershort peripheral venous catheter place in the forearm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age >18 years
- Expected duration of infusion therapy by short peripheral intravenous catheters >7 days
- Give written informed consent
Key exclusion criteria (4 listed)
- The peripheral venous catheter was inserted in emergency room or in emergency circumstances
- Bloodstream infection
- Had a peripheral venous catheter already in situ at the baseline
- Altered mental state
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 |
|---|---|---|
| short peripheral venous cathetershort peripheral venous catheter for infusion therapy in adult patients | Device | Dorsum of hand group, Forearm group |
Primary outcome
Indwelling time
Time frame: from the cannulae insertion until its removal, usually within 2 weeks
6 secondary outcomes
Phlebitis
Time frame: from the cannulae insertion until its removal, usually within 2 weeks
Occlusion of the catheter
Time frame: from the cannulae insertion until its removal, usually within 2 weeks
Infiltration
Time frame: from the cannulae insertion until its removal, usually within 2 weeks
Accidental catheter removal
Time frame: from the cannulae insertion until its removal, usually within 2 weeks
Local venous infection
Time frame: from the cannulae insertion until its removal, usually within 2 weeks
Catheter-related bloodstream infection
Time frame: from the cannulae insertion until its removal, usually within 2 weeks
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 8 Jan 2019.
Related trials for Short Peripheral Venous Catheter
Not yet recruiting
A Brief Intervention by Nurses to Reduce the Prescribing of Occluded Peripheral Venous Catheters in the Emergency Department
an Initial Order for a Blood Draw and Placement of an IV Line in the Emergency Department
Not yet recruiting
Ultrasound-Guided Long vs Short Peripheral IV Catheters in Neonates With Congenital Syphilis Receiving Antibiotics
Infant, Newborn, Syphilis, Congenital
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.
Chuanjie Wu, MD study chair
The First Affiliated Hospital of Zhengzhou University
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing short peripheral venous catheter in people with Short Peripheral Venous Catheter, run by The First Affiliated Hospital of Zhengzhou University at 6 sites 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 4 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 8 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
Indwelling time (time frame: from the cannulae insertion until its removal, usually within 2 weeks). 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 8 Jan 2019.