Point of Care UltraSound (POCUS) Use for Intravenous Cath... | NCT04875988

Studies
Point of Care UltraSound (POCUS) Use for Intravenous Catheter Placement During Pediatric Interfacility Transport

NCT04875988

Sponsor

Arkansas Children's Hospital Research Institute

Status

Unknown status

Last Update Posted

Oct 15, 2021Actual

Enrollment

66Estimated

Phase

Not Applicable

Conditions

Intravenous Access

Interventions

Butterfly iQ+ Ultrasound
Traditional

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2021Estimated

Primary Completion Date

Dec 2022Estimated

Completion Date

Dec 2022Estimated

First Submitted Date

May 3, 2021

First Submission Date that Met QC Criteria

May 5, 2021

First Posted Date

May 6, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 7, 2021

Last Update Posted Date

Oct 15, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

66Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Butterfly iQ+ Ultrasound	Procedure	ultrasound will be used in the intervention group for IV access	POCUS-assisted IV placement

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
First Attempt IV success rates		1 day of transfer

Secondary Outcomes

Measure	Description	Time Frame
Beside Times during transport	as reported (in minutes)	up to 24 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Adequate IV Access
NICU transports
Patients not needing IV access

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Weeks

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Michael H Stroud, MD	Contact	501-364-1861		StroudMichaelH@uams.edu

Overall Officials

Name	Affiliation	Role
Michael H Stroud, MD	University of Arkansas	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided