Passive Leg Raise for Pediatric Peripheral IV Placement

Not Applicable

Completed

• Conditions: Anesthesia; Children, Only

• Registration Number: NCT05298137
• Lead Sponsor: University of Saskatchewan

Brief Summary

The investigators hypothesize peripheral intravenous cannulation (insertion of tube into vein) will be facilitated (decreases the number of attempts) by a passive leg raise (raising the legs at the hip to 45 degree in a child laying on their back) in children.

Detailed Description

Establishing peripheral intravenous (PIV) access in the pediatric population is challenging even in the hands of skilled practitioners.

A passive leg raise (PLR), raising a patient's legs to a 45 degree angle while supine, auto-transfuses the blood volume within the patient's lower extremities into the central venous compartment. Increasing the blood volume in the central venous compartment may also increase the volume and caliber of upper extremity peripheral veins. It remains to be studied whether a PLR increases peripheral vein diameter and if this would facilitate the placement of PIVs in the pediatric population.

Study Timeline

• Study First Submitted: 2022-03-06
• Study First Submitted QC: 2022-03-16
• Study First Posted: 2022-03-28
• Study Start: 2022-05-10
• Primary Completion: 2022-07-30
• Study Completion: 2022-07-30
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-01
• Last Update Posted: 2022-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 234

Inclusion Criteria

• Children ages 3 months to 17 years.
• American Society of Anesthesiology (ASA) physical status 1-3 scheduled for elective surgical procedures under general anesthesia.

Exclusion Criteria

• Children undergoing procedures who already have adequate IV access (ie pre-established central or peripheral access).
• Those greater than the age of 17, as this is the age limit for care at the Jim Pattison Children's Hospital.
• Those with any lower limb pathology that limits range of motion.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The number of attempts to successful catheterization.	During the intraoperative procedure.	The study's primary outcome (number of peripheral IV attempts) will be analyzed using a Chi-square test.

Secondary Outcome Measures

Name	Time	Method
Provider perception of PLR on vein palpation.	Immediately following successful cannulation in the experimental group.	Chi-square testing will be used to evaluate provider perception of passive leg raise on vein visualization and palpation.
Provider perception of PLR on vein visualization.	Immediately following successful cannulation in the experimental group.	Chi-square testing will be used to evaluate provider perception of passive leg raise on vein visualization and palpation.
Time from skin puncture to the confirmation of a functioning peripheral line.	Measured intraoperatively, an expected estimated average of 2 minutes.	Time to vein cannulation will be compared using the student's t test.
The mean change in peripheral vein diameter following passive leg raise, assessed on ultrasonography.	During the intraoperative procedure.	The change, if any, in peripheral vein diameter will be measured by comparing the diameter assessed by ultrasound at baseline and following leg raise. Results will be compared using the student's t test.

Trial Locations

Locations (1)

Jim Pattison Children's Hospital; 🇨🇦 Saskatoon, Saskatchewan, Canada