Ultrasound-guided Peripheral Intravenous Catheter Placement in an Oncologic Emergency Department - a Prospective, Randomized Controlled Trial of Catheter Lengths

Oncologic Complications and Emergencies Clinical Trial

Official title:

Ultrasound-guided Peripheral Intravenous Catheter Placement in an Oncologic Emergency Department - a Prospective, Randomized Controlled Trial of Catheter Lengths

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06217783
• Other study ID #: 2023-0848
• Secondary ID: NCI-2024-00503
• Status: Recruiting
• Phase: N/A
• Start date: March 27, 2024
• Est. completion date: June 30, 2027

Study information

• Verified date: March 2024
• Source: M.D. Anderson Cancer Center
• Contact: Jonathan Rowland, MD
• Phone: (832) 450-8954
• Email: jwrowland[@]mdanderson.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To learn about the effects of the length of the catheter on the failure and success rate of USIV placement.

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:

1. Time from catheter placement to removal (i.e. survival or dwell time).

2. Per catheter length rate of failure analysis

3. Rate of repeat catheterization

4. Rate of infection

5. Rate of thrombosis

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: June 30, 2027
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age > 18 years old.

2. Provision of signed and dated informed consent form.

3. Predetermined to have difficult IV access necessitating USIV placement

4. Expected admission to hospital with anticipated stay > 48 hours (per discussion with treating physician).

Exclusion Criteria:

1. Expected/anticipated discharge disposition from the ACCC (per discussion with treating physician).

2. Inability to give informed consent.

3. Pregnant women.

4. Non-English speaking participants.

Related Conditions & MeSH terms

• Emergencies
• Oncologic Complications and Emergencies

Intervention

Device:
• Introcan Safety IV Catheter
Given by IV

Locations

Country	Name	City	State
United States	MD Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and adverse events (AEs)	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.

External Links

•   MD Anderson Cancer Center