Ultrasound-guided Peripheral Intravenous Catheter Placement in an Oncologic Emergency Department - a Prospective, Randomized Controlled Trial of Catheter Lengths
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Primary Objectives:
- The rate of catheter failure, defined as removal of the catheter for any reason other than "Care Complete" (i.e. a composite of removal due to "infiltration," "leaking," "catheter damage," "occlusion"), by day 10.
Secondary Objectives:
- Time from catheter placement to removal (i.e. survival or dwell time).
- Per catheter length rate of failure analysis
- Rate of repeat catheterization
- Rate of infection
- Rate of thrombosis
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Jonathan Rowland, MD
- Phone Number: (832) 450-8954
- Email: jwrowland@mdanderson.org
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- Recruiting
- MD Anderson Cancer Center
-
Contact:
- Jonathan Rowland, MD
- Phone Number: 832-450-8954
- Email: jwrowland@mdanderson.org
-
Principal Investigator:
- Jonathan Rowland, MD
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age > 18 years old.
- Provision of signed and dated informed consent form.
- Predetermined to have difficult IV access necessitating USIV placement
- Expected admission to hospital with anticipated stay > 48 hours (per discussion with treating physician).
Exclusion Criteria:
- Expected/anticipated discharge disposition from the ACCC (per discussion with treating physician).
- Inability to give informed consent.
- Pregnant women.
- Non-English speaking participants.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Group A
Participants will receive a catheter that is up to 1.75 inches long based on what the nurse thinks is best for you.
|
Given by IV
|
|
Experimental: Group B
Participants will receive a catheter that is either 1.75 or 2.5 inches long based on what the nurse thinks is best for you.
|
Given by IV
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Safety and adverse events (AEs)
Time Frame: Through study completion; an average of 1 year.
|
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
|
Through study completion; an average of 1 year.
|
Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: Jonathan Rowland, MD, M.D. Anderson Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- 2023-0848
- NCI-2024-00503 (Other Identifier: NCI-CTRP Clinical Registry)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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