Passive Leg Raise for Pediatric Peripheral IV Placement

NCT05298137 | Completed

• 1 other identifier: Bio #3221
• Study Type: interventional
• Target: 234
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia; Children, Only

Keywords

Pediatrics; Anesthesiology; Cannula; Anesthesia, Intravenous; Catheterization

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

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

  During the intraoperative procedure.

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

  Measured intraoperatively, an expected estimated average of 2 minutes.

• Provider perception of PLR on vein visualization.

  Immediately following successful cannulation in the experimental group.

• Provider perception of PLR on vein palpation.

  Immediately following successful cannulation in the experimental group.

Study Arms (2)

IV Cannulation Without Passive Leg Raise

NO INTERVENTION

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.

IV Cannulation With Passive Leg Raise

EXPERIMENTAL

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

Interventions

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.

IV Cannulation With Passive Leg Raise

Eligibility Criteria

• Age: 3 Months - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Saskatchewan: lead

Study Sites (1)

Jim Pattison Children's Hospital

Saskatoon, Saskatchewan, S7N 0W8, Canada

Location

Study Officials

• Jonathan J Gamble, MD

  Department of Anesthesiology, University of Saskatchewan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Executive Director of Research for the Department of Anesthesiology, College of Medicine, University of Saskatchewan

Model Details: The investigators propose a prospective, parallel group, open-label randomized controlled trial.

Study Record Dates

• First Submitted: March 6, 2022
• First Posted: March 28, 2022
• Study Start: May 10, 2022
• Primary Completion: July 30, 2022
• Study Completion: July 30, 2022
• Last Updated: November 3, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)