Ultrasound Guided Versus Landmark Guided Arterial Line Placement by Emergency Medicine Interns

• Sponsor: Temple University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03326739
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Actual Duration (Months): 35.9
• Patients Per Site Per Month: 1.1

Study Details

Study Description

Brief Summary

Critically ill patients in the emergency department commonly require arterial line placement for continuous direct blood pressure monitoring, frequent arterial blood gas sampling, and frequent blood sampling. Trans-radial catheterization has been shown to reduce access site complications and increase patient comfort compared to trans-femoral access. Radial artery access on the first attempt is optimal; attempts at reentry delay care and increase the risk of vascular spasm, hematoma, infection, neurovascular injury, and pain. The traditional pulse palpation method of radial artery cannulation can be challenging, especially in patients with weak pulses (i.e. morbidly obese or hypotensive individuals).

A review of literature suggests that ultrasound guided trans-radial catheterization compared to standard pulse palpation reduces access time and increases rate of first-entry success when performed by physicians trained in ultrasound. Thus, complications ascribed to reentry are prevented and timely care is provided.

To the investigator's knowledge, only one other prospective study has been conducted to assess the utility of ultrasound guided radial artery cannulation in the emergency department. Due to the paucity of literature to support the use of ultrasound guided trans-radial catheterization in critically ill patients, the study will aim to provide further data on the topic. Both techniques are considered standard of care.

Condition or Disease	Intervention/Treatment	Phase
Vascular Access Complication	Procedure: Arterial Line Placement	N/A

Detailed Description

Patients presenting to the Emergency Department 18 years old or greater, who do not belong to a vulnerable group, requiring arterial line placement will be included in this trial. The investigators will randomize each patient into LM vs US. Data collected will include number of attempts, success rate, and time for procedure to be completed. PGY-1 residents will perform the arterial line placement.

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Care Provider)
• Primary Purpose: Diagnostic
• Official Title: Ultrasound Guided Versus Landmark Guided Arterial Line Placement by Emergency Medicine Interns
• Actual Study Start Date: Jan 1, 2017
• Actual Primary Completion Date: Dec 31, 2019
• Actual Study Completion Date: Dec 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Ultrasound Guided A-Line Placement Patients in this group will have ultrasound guided arterial line placement.	Procedure: Arterial Line Placement; arterial line placement
Active Comparator: Landmark Guided A-line Placement Patients in this group will have landmark guided arterial line placement.	Procedure: Arterial Line Placement; arterial line placement

Outcome Measures

Primary Outcome Measures

1. Superiority of Method of arterial line placement [1 day]

   Number of attempts until successful cannulation.

Secondary Outcome Measures

1. Success of method [1 day]

   Completion of arterial line placement after three attempts

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 99 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Patients requiring arterial line placement.

Exclusion Criteria:

• Adults Unable to Consent

• Members of Vulnerable Populations

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Lewis Katz School of Medicine at Temple University	Philadelphia	Pennsylvania	United States	19140

Sponsors and Collaborators

• Temple University

Investigators

• Principal Investigator: Ryan C Gibbons, MD, Lewis Katz School of Medicine at Temple University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Temple University
• ClinicalTrials.gov Identifier: NCT03326739
• Other Study ID Numbers: 24642
• First Posted: Oct 31, 2017
• Last Update Posted: Jan 22, 2020
• Last Verified: Jan 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Emergencies

Study Results

No Results Posted as of Jan 22, 2020