Ultrasound-guided Peripheral Vascular Access in Children | NCT02556541

Studies
Ultrasound-guided Peripheral Vascular Access in Children

NCT02556541

Sponsor

University of Aarhus

Status

Unknown status

Last Update Posted

Mar 7, 2016Estimated

Enrollment

50Estimated

Phase

Not Applicable

Conditions

Ultrasonography
Vascular Access Devices
Pediatrics

Interventions

IV puncture guided by ultrasound

Countries

Denmark

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

Apr 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2015

Primary Completion Date

Aug 2016Estimated

Completion Date

Not provided

First Submitted Date

Sep 15, 2015

First Submission Date that Met QC Criteria

Sep 18, 2015

First Posted Date

Sep 22, 2015Estimated

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

Mar 4, 2016

Last Update Posted Date

Mar 7, 2016Estimated

Description Module

Brief Summary

The purpose of this investigation is to conduct a randomized, patient-blinded prospective controlled trial comparing peripheral intravenous cannulation in children done by:

Conventional landmark cannulation where the intravenous cannulation is done by direct visual guidance or palpation or a combination thereof.
Ultrasound guided cannulation by means of DNTP.

The investigators hypothesize that with ultrasound-guided peripheral intravenous cannulation the first-attempt success rate will be significantly higher than by the conventional landmark cannulation technique.

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

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Name	Type	Description	Arm Group Labels	Other Names
IV puncture guided by ultrasound	Procedure

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
First attempt success	Succes rate of first attempt cannulation for ultrasound and traditional method will be compared.	Intraoperative

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Requirement for anaesthesia before MRI or operation.
Routine need of peripheral intravenous cannulation.
Age 0- 3 years at the date of MR scan

Exclusion Criteria:

Lack of consent
Emergency patients needing immediate operation or scan.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

3 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Nigopan Gopalasingam	Contact	+45 31535950		20103907@post.au.dk

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Anaesthesiology and Intensive Care	Recruiting	Aarhus		8200	Denmark