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Completed

NCT Number: NCT05298137

Passive Leg Raise for Pediatric Peripheral IV Placement

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.

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Key information

Conditions

Anesthesia Children, Only

Age range

3 month–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jim Pattison Children's Hospital

Saskatoon, Saskatchewan, S7N 0W8, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Passive Leg Raise

Procedure

A passive leg raise (PLR) is defined as raising a patient's legs to a 45-degree angle at the hip while supine.

Primary outcomes

  1. The number of attempts to successful catheterization.

    Time frame: During the intraoperative procedure.

    The study's primary outcome (number of peripheral IV attempts) will be analyzed using a Chi-square test.

Secondary outcomes

  1. The mean change in peripheral vein diameter following passive leg raise, assessed on ultrasonography.

    Time frame: 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.

  2. Time from skin puncture to the confirmation of a functioning peripheral line.

    Time frame: Measured intraoperatively, an expected estimated average of 2 minutes.

    Time to vein cannulation will be compared using the student's t test.

  3. Provider perception of PLR on vein visualization.

    Time frame: 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.

  4. Provider perception of PLR on vein palpation.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Saskatchewan

Other

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Mar 28, 2022
Registry last updated
Nov 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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