Comparison of Ultrasound Guided Peripheral IV Placement With and Without Use of a Guidewire

• Sponsor: Brigham and Women's Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02422472
• Collaborator: (none)
• Enrollment: 70
• Location: 1
• Arms: 2
• Duration (Months): 36
• Patients Per Site Per Month: 1.9

Study Details

Study Description

Brief Summary

The purpose of this study is to compare ultrasound guided peripheral IV placement with and without the use of a guidewire. Patients in the Emergency Department with difficult peripheral IV access (as defined by 2 failed attempts by nursing staff) will be consented and randomized to standard ultrasound guided peripheral IV placement or ultrasound guided peripheral IV placement with modified seldinger technique using a guidewire.

Condition or Disease	Intervention/Treatment	Phase
Difficult Peripheral IV Access	Device: Ultrasound guided peripheral IV placement	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 70 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Comparison of Ultrasound Guided Peripheral IV Placement With and Without Use of a Guidewire
• Study Start Date: Jun 1, 2015
• Actual Primary Completion Date: Jun 1, 2018
• Actual Study Completion Date: Jun 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Standard Standard of care ultrasound guided peripheral IV placement
Experimental: Experimental Ultrasound guided peripheral IV placement with the use of a guidewire	Device: Ultrasound guided peripheral IV placement; Accucath™ 20 Gax 5.7cm catheter

Outcome Measures

Primary Outcome Measures

1. First attempt success rate [60 minutes]

   First attempt success is defined as ability to place and use the catheter after only one attempt and will be reported by study staff.

Secondary Outcome Measures

1. Overall success rate [60 minutes]

   Overall success is defined as ability to place and use the catheter (after 2 or fewer attempts) and will be reported by study staff.

2. Number of skin punctures [60 minutes]

   Number of skin punctures will be recorded by study staff.

3. Complications including hematoma, IV infiltration, catheter dislodge [3 days]

   Patients will be monitored for complications of IV placement by study staff

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Difficult peripheral IV access (2 failed attempts by nursing staff)

• Prior history of difficult IV access and patient request for ultrasound guided IV

Exclusion Criteria:

• Need for emergent access or central venous access

• Inability to provide informed consent

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Brigham and Women's Hospital	Boston	Massachusetts	United States	02115

Sponsors and Collaborators

• Brigham and Women's Hospital

Investigators

• Principal Investigator: Heidi Kimberly, MD, Brigham and Women's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Heidi Kimberly, Associate Physician Emergency Medicine Brigham and Women's Hospital, Instructor in Emergency Medicine Harvard Medical School, Brigham and Women's Hospital
• ClinicalTrials.gov Identifier: NCT02422472
• Other Study ID Numbers: 2015P000073
• First Posted: Apr 21, 2015
• Last Update Posted: Jan 16, 2019
• Last Verified: Jan 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No

Study Results

No Results Posted as of Jan 16, 2019