- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03290573
Site Selection of Short Peripheral Venous Catheters (SPECIAL)
January 7, 2019 updated by: Chuanjie Wu, The First Affiliated Hospital of Zhengzhou University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
1517
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Anhui
-
Suzhou, Anhui, China
- Suzhou Municipal Hospital
-
-
Beijing
-
Beijing, Beijing, China
- Xuanwu Hospital Captial Medical University
-
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Guizhou
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Guiyang, Guizhou, China
- Guizhou Provincial People's Hospital
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Henan
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Zhengzhou, Henan, China, 450000
- The First Affiliated hospital of Zhengzhou University
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Zhengzhou, Henan, China
- The fifth Affiliated Hospital of Zhengzhou University
-
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Hunan
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Xiangtan, Hunan, China
- Xiangtan Central Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age >18 years
- Expected duration of infusion therapy by short peripheral intravenous catheters >7 days
- Give written informed consent
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Dorsum of hand group
short peripheral venous catheter place in the dorsum of the hand
|
short peripheral venous catheter for infusion therapy in adult patients
|
Experimental: Forearm group
short peripheral venous catheter place in the forearm
|
short peripheral venous catheter for infusion therapy in adult patients
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Indwelling time
Time Frame: from the cannulae insertion until its removal, usually within 2 weeks
|
from the cannulae insertion until its removal, usually within 2 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Phlebitis
Time Frame: from the cannulae insertion until its removal, usually within 2 weeks
|
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
|
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
|
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
|
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
|
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
|
from the cannulae insertion until its removal, usually within 2 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Chuanjie Wu, MD, The First Affiliated hospital of Zhengzhou University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 29, 2017
Primary Completion (Actual)
December 26, 2018
Study Completion (Actual)
January 6, 2019
Study Registration Dates
First Submitted
September 17, 2017
First Submitted That Met QC Criteria
September 20, 2017
First Posted (Actual)
September 25, 2017
Study Record Updates
Last Update Posted (Actual)
January 8, 2019
Last Update Submitted That Met QC Criteria
January 7, 2019
Last Verified
January 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- FAHZU-2017-016
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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