Clinical trial NCT05298137: Passive Leg Raise for Pediatric Peripheral IV Placement
Official title: Passive Leg Raise for Pediatric Peripheral IV Placement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia
Children, Only
Keywords: Pediatrics
Anesthesiology
Cannula
Anesthesia, Intravenous
Catheterization
Lead sponsor: University of Saskatchewan
Sponsor class: OTHER
First posted: 2022-03-28
Enrollment: 234
Sex: ALL
Minimum age (years): 3
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The investigators propose a prospective, parallel group, open-label randomized controlled trial.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The number of attempts to successful catheterization.
timeFrame: During the intraoperative procedure.
Secondary outcomes:
measure: The mean change in peripheral vein diameter following passive leg raise, assessed on ultrasonography.
timeFrame: During the intraoperative procedure.
measure: Time from skin puncture to the confirmation of a functioning peripheral line.
timeFrame: Measured intraoperatively, an expected estimated average of 2 minutes.
measure: Provider perception of PLR on vein visualization.
timeFrame: Immediately following successful cannulation in the experimental group.
measure: Provider perception of PLR on vein palpation.
timeFrame: Immediately following successful cannulation in the experimental group.
Other outcomes:
Locations:
city: Saskatoon
country: Canada
facility: Jim Pattison Children's Hospital
state: Saskatchewan
Study officials:
affiliation: Department of Anesthesiology, University of Saskatchewan
name: Jonathan J Gamble, MD
role: PRINCIPAL_INVESTIGATOR
References: