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

Not Applicable

Recruiting

• Conditions: Oncologic Complications and Emergencies
• Interventions: Device: Introcan Safety IV Catheter

• Registration Number: NCT06217783
• Lead Sponsor: M.D. Anderson Cancer Center

Brief Summary

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

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:

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

Study Timeline

• Study First Submitted: 2024-01-10
• Study First Submitted QC: 2024-01-12
• Study First Posted: 2024-01-22
• Study Start: 2024-03-27
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-03
• Last Update Posted: 2025-04-06
• Primary Completion: 2025-06-30
• Study Completion: 2027-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	Introcan Safety IV Catheter	Participants will receive a catheter that is up to 1.75 inches long based on what the nurse thinks is best for you.
Group B	Introcan Safety IV Catheter	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.

Primary Outcome Measures

Name	Time	Method
Safety and adverse events (AEs)	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)

Trial Locations

Locations (1)

MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States