NCT04875988

Brief Summary

This study will determine the efficacy of POCUS (Point of Care UltraSound) for intravenous (IV) access during pediatric interfacility transport. The Butterfly iQ+ (Lightning) device will be used. Children requiring IV access for transport will be randomized to POCUS-Assisted IV placement or traditional IV placement. We will examine and compare first attempt success rates with each method.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2021

Status
unknown

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

May 3, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 6, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

October 1, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

October 15, 2021

Status Verified

October 1, 2021

Enrollment Period

1.2 years

First QC Date

May 3, 2021

Last Update Submit

October 7, 2021

Conditions

Intravenous Access

Keywords

pediatricsinterfacility transportintravenous accessultrasoundPOCUS

Outcome Measures

Primary Outcomes (1)

  • First Attempt IV success rates

    1 day of transfer

Secondary Outcomes (1)

  • Beside Times during transport

    up to 24 hours

Study Arms (2)

POCUS-assisted IV placement

ACTIVE COMPARATOR

using ultrasound to help with placement

Procedure: Butterfly iQ+ Ultrasound

Traditional IV placement

ACTIVE COMPARATOR

Standard of care

Procedure: Traditional

Interventions

Butterfly iQ+ UltrasoundPROCEDURE

ultrasound will be used in the intervention group for IV access

POCUS-assisted IV placement
TraditionalPROCEDURE

ultrasound will not be used in the traditional IV placement group

Traditional IV placement

Eligibility Criteria

Age2 Weeks - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Pediatric patients requiring IV access prior to transport by the Angel One Transport Team back to Arkansas Children's Hospital
  • Age group: 2 weeks - 18 years

You may not qualify if:

  • Adequate IV Access
  • NICU transports
  • Patients not needing IV access

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Michael H Stroud, MD

    University of Arkansas

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael H Stroud, MD

CONTACT

501-364-1861StroudMichaelH@uams.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 3, 2021

First Posted

May 6, 2021

Study Start

October 1, 2021

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

October 15, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share