NCT01276158

Brief Summary

This prospective randomized study was designed to compare ultrasound guided technique with Doppler assisted technique for radial arterial cannulation in infant and small children.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
104

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2011

Shorter than P25 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

First Submitted

Initial submission to the registry

January 11, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 13, 2011

Completed
4 months until next milestone

Study Start

First participant enrolled

May 1, 2011

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

March 13, 2017

Status Verified

March 1, 2017

Enrollment Period

7 months

First QC Date

January 11, 2011

Last Update Submit

March 9, 2017

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (1)

  • The primary object is to compare the first attempt success rate between each group.

    10 minutes

Secondary Outcomes (1)

  • As a secondary object, a comparison will be made between groups for overall Success rate within a 10 minute time period.

    10 minutes

Study Arms (2)

Ultrasound

ACTIVE COMPARATOR

Arterial line placed with Ultrasound guidance.

Procedure: Ultrasound

Doppler

ACTIVE COMPARATOR

Arterial line placed with doppler guidance

Procedure: Doppler

Interventions

UltrasoundPROCEDURE

Ultrasound used to place arterial line

Ultrasound
DopplerPROCEDURE

Doppler used to place arterial line

Doppler

Eligibility Criteria

AgeUp to 48 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Pediatric patient undergoing scheduled major surgery which require continuous arterial pressure monitoring
  • Term neonates and children \< 4 years old weighing \>/= 3 kg and \< 12 kg

You may not qualify if:

  • Patients with a skin wound or infection around puncture site
  • Abnormal circulation in the hand (known vascular compromise, mottling, cool skin temp relative to other hand, poor capillary refill)
  • Recent radial arterial puncture (less than 1 month)
  • Any emergency surgery or profound hemodynamic instability requiring urgent arterial cannulation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Interventions

High-Energy Shock Waves

Intervention Hierarchy (Ancestors)

Ultrasonic WavesSoundRadiation, NonionizingRadiationPhysical Phenomena

Study Officials

  • Kenichi Ueda, MD

    University of Iowa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Associate Professor

Study Record Dates

First Submitted

January 11, 2011

First Posted

January 13, 2011

Study Start

May 1, 2011

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

March 13, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)