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.

Study Overview

• Status: Completed
• Conditions: Anesthesia; Children, Only
• Intervention / Treatment: Procedure: Passive Leg Raise

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 Type: Interventional
• Enrollment (Actual): 234
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada, S7N 0W8
      • Jim Pattison Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 months to 17 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: IV Cannulation Without Passive Leg Raise; Patients will be randomized to either the passive leg raise (PLR) group or standard care (control group). In both groups baseline measurements of a peripheral vein diameter using ultrasound will be undertaken at the level of the left antecubital fossa with and without a proximally placed venous tourniquet. Those in the control group will then have a peripheral IV (PIV) placed in the ipsilateral arm as the baseline measurements, the number of attempts to successful PIV placement will be recorded. A repeat diameter assessment of the previously assessed vein, number of PIV attempts, and time to successful IV cannulation (measured as the time from skin puncture to successful IV cannulation) will be recorded.
EXPERIMENTAL: IV Cannulation With Passive Leg Raise; Patients will be randomized to either the passive leg raise (PLR) group or standard care (control group). In both groups baseline measurements of a peripheral vein diameter using ultrasound will be undertaken at the level of the left antecubital fossa with and without a proximally placed venous tourniquet. Those in the passive leg raise (PLR) group will have their legs elevated to 45 degrees until successful peripheral IV (PIV) placement. A repeat diameter assessment of the previously assessed vein, number of PIV attempts, and time to successful IV cannulation (measured as the time from skin puncture to successful IV cannulation) will be recorded.	Procedure: Passive Leg Raise; A passive leg raise (PLR) is defined as raising a patient's legs to a 45-degree angle at the hip while supine.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Saskatchewan
• Investigators: Principal Investigator: Jonathan J Gamble, MD, Department of Anesthesiology, University of Saskatchewan

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 10, 2022
• Primary Completion (ACTUAL): July 30, 2022
• Study Completion (ACTUAL): July 30, 2022

Study Registration Dates

• First Submitted: March 6, 2022
• First Submitted That Met QC Criteria: March 16, 2022
• First Posted (ACTUAL): March 28, 2022

Study Record Updates

• Last Update Posted (ACTUAL): November 3, 2022
• Last Update Submitted That Met QC Criteria: November 1, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Pediatrics; Cannula; Anesthesiology; Catheterization; Anesthesia, Intravenous
• Other Study ID Numbers: Bio #3221

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Aggregate results will be presented in manuscript form but no individual participant data (IPD) will be shared.

Drug and device information, study documents

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