NCT03029754

Brief Summary

The investigators wish to determine whether passive leg raise allows for easier peripheral vascular access in the pediatric population. The investigators hypothesize that pediatric anesthesiologists will have higher rates of successful intravenous catheterization in children where a passive leg raise is employed.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
87

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2017

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 19, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 24, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

May 17, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 14, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 14, 2017

Completed
Last Updated

January 9, 2019

Status Verified

January 1, 2019

Enrollment Period

7 months

First QC Date

January 19, 2017

Last Update Submit

January 8, 2019

Conditions

Intravenous Access

Outcome Measures

Primary Outcomes (1)

  • Mean change in peripheral vein diameter

    Change between vein diameter at baseline and following group allocation.

    at 5 minutes

Study Arms (2)

Passive leg raise

EXPERIMENTAL

Participant's legs will be raised with a bolster prior to IV insertion.

Procedure: Passive leg raise

No leg raise

NO INTERVENTION

Participants will lie flat prior to IV insertion.

Interventions

Passive leg raisePROCEDURE

A baseline vein diameter will be obtained using ultrasound by the sub-investigator. Then a nurse will raise the child's legs using a bolster while a second measurement of the child's vein diameter is recorded by the sub-investigator. The anesthesiologist will then place the IV and rate the degree of difficulty encountered.

Passive leg raise

Eligibility Criteria

Age3 Months - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • pediatric participants undergoing dental procedures under general anesthesia

You may not qualify if:

  • Children who already have adequate IV access

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal University Hospital

Saskatoon, Saskatchewan, S7N 0W8, Canada

Location

Study Officials

  • Jonathan Gamble, MD

    University of Saskatchewan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

January 19, 2017

First Posted

January 24, 2017

Study Start

May 17, 2017

Primary Completion

December 14, 2017

Study Completion

December 14, 2017

Last Updated

January 9, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)