NCT03326739

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 17, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 31, 2017

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

January 22, 2020

Status Verified

January 1, 2020

Enrollment Period

3 years

First QC Date

October 17, 2017

Last Update Submit

January 20, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Superiority of Method of arterial line placement

    Number of attempts until successful cannulation.

    1 day

Secondary Outcomes (1)

  • Success of method

    1 day

Study Arms (2)

Ultrasound Guided A-Line Placement

ACTIVE COMPARATOR

Patients in this group will have ultrasound guided arterial line placement.

Procedure: Arterial Line Placement

Landmark Guided A-line Placement

ACTIVE COMPARATOR

Patients in this group will have landmark guided arterial line placement.

Procedure: Arterial Line Placement

Interventions

arterial line placement

Landmark Guided A-line PlacementUltrasound Guided A-Line Placement

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients requiring arterial line placement.

You may not qualify if:

  • Adults Unable to Consent
  • Members of Vulnerable Populations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lewis Katz School of Medicine at Temple University

Philadelphia, Pennsylvania, 19140, United States

Location

Study Officials

  • Ryan C Gibbons, MD

    Lewis Katz School of Medicine at Temple University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 17, 2017

First Posted

October 31, 2017

Study Start

January 1, 2017

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

January 22, 2020

Record last verified: 2020-01

Locations