Passive Leg Raise for Pediatric Peripheral IV Placement

Anesthesia Clinical Trial

Official title:

Passive Leg Raise for Pediatric Peripheral IV Placement

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05298137
• Other study ID #: Bio #3221
• Status: Completed
• Phase: N/A
• Start date: May 10, 2022
• Est. completion date: July 30, 2022

Study information

• Verified date: November 2022
• Source: University of Saskatchewan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 234
• Est. completion date: July 30, 2022
• Est. primary completion date: July 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Months to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anesthesia
• Children, Only

Intervention

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.

Locations

Country	Name	City	State
Canada	Jim Pattison Children's Hospital	Saskatoon	Saskatchewan

Sponsors (1)

Lead Sponsor	Collaborator
University of Saskatchewan

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.