NCT02556541

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:

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

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

September 1, 2015

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

September 15, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 22, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Last Updated

March 7, 2016

Status Verified

April 1, 2015

Enrollment Period

11 months

First QC Date

September 15, 2015

Last Update Submit

March 4, 2016

Conditions

UltrasonographyVascular Access DevicesPediatrics

Outcome Measures

Primary Outcomes (1)

  • First attempt success

    Succes rate of first attempt cannulation for ultrasound and traditional method will be compared.

    Intraoperative

Interventions

IV puncture guided by ultrasoundPROCEDURE

Eligibility Criteria

AgeUp to 3 Years
Sexall
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • Lack of consent
  • Emergency patients needing immediate operation or scan.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anaesthesiology and Intensive Care

Aarhus, 8200, Denmark

RECRUITING

Central Study Contacts

Nigopan Gopalasingam

CONTACT

+45 3153595020103907@post.au.dk

Study Design

Study Type
interventional
Phase
not applicable
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 15, 2015

First Posted

September 22, 2015

Study Start

September 1, 2015

Primary Completion

August 1, 2016

Last Updated

March 7, 2016

Record last verified: 2015-04

Locations

DK(1)