NCT02557828

Brief Summary

Invasive blood pressure monitoring is achieved by cannulating an artery and transducing the pressure. During arterial cannulation the artery can be located by palpation, but use of ultrasound has increased the success rate of cannulation. A new ultrasound technique for vascular cannulation (dynamic needle tip positioning) has been described. Investigators aim to compare this technique to the palpation technique for arterial cannulation. Investigators hypothesize that the use of this novel ultrasound technique will result in a higher first attempt success rate and overall success compared to palpation. Investigators plan to enroll 310 patients in this study. The participants in the study will have been deemed by the attending anesthesiologist to require a radial arterial line for the operation and thus the research protocol will not involve a deviation from the standard of care.

Trial Health

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Trial Health Score

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

Enrollment
260

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2015

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 22, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 23, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

June 2, 2017

Status Verified

June 1, 2017

Enrollment Period

11 months

First QC Date

September 22, 2015

Last Update Submit

June 1, 2017

Conditions

Radial Artery Cannulation

Outcome Measures

Primary Outcomes (1)

  • first pass success

    placement of arterial cannula in 5 minutes after touching the wrist

    5 minutes

Secondary Outcomes (1)

  • overall success

    5 minutes

Study Arms (2)

palpation

ACTIVE COMPARATOR

participants who are randomized to have radial arterial cannulation via palpation technique

Procedure: arterial line placement

ultrasound

ACTIVE COMPARATOR

participants who are randomized to have radial arterial cannulation via a new ultrasound technique

Procedure: arterial line placement

Interventions

arterial line placementPROCEDURE

radial arterial cannulation placed via palpation or ultrasound technique

palpationultrasound

Eligibility Criteria

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

You may qualify if:

  • needing radial arterial cannulation intraoperatively

You may not qualify if:

  • refusal to consent
  • minors
  • incarcerated individuals
  • radial cannulation within past month
  • negative modified Allen's test
  • shock
  • non-English speaking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate- Physician

Study Record Dates

First Submitted

September 22, 2015

First Posted

September 23, 2015

Study Start

May 1, 2015

Primary Completion

April 1, 2016

Study Completion

November 1, 2016

Last Updated

June 2, 2017

Record last verified: 2017-06

Locations

US(1)