Effect of Passive Leg Raise for Pediatric Peripheral IV Placement

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.

Study Overview

• Status: Completed
• Conditions: Intravenous Access
• Intervention / Treatment: Procedure: Passive leg raise

• Study Type: Interventional
• Enrollment (Actual): 87
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada, S7N 0W8
      • Royal University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 months to 14 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• pediatric participants undergoing dental procedures under general anesthesia

Exclusion Criteria:

• Children who already have adequate IV access

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Passive leg raise; Participant's legs will be raised with a bolster prior to IV insertion.	Procedure: Passive leg raise; 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.
No Intervention: No leg raise; Participants will lie flat prior to IV insertion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean change in peripheral vein diameter	Change between vein diameter at baseline and following group allocation.	at 5 minutes

Collaborators and Investigators

• Sponsor: University of Saskatchewan

Study record dates

Study Major Dates

• Study Start (Actual): May 17, 2017
• Primary Completion (Actual): December 14, 2017
• Study Completion (Actual): December 14, 2017

Study Registration Dates

• First Submitted: January 19, 2017
• First Submitted That Met QC Criteria: January 20, 2017
• First Posted (Estimate): January 24, 2017

Study Record Updates

• Last Update Posted (Actual): January 9, 2019
• Last Update Submitted That Met QC Criteria: January 8, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: Bio 16-331

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No