An interventional study of Passive Leg Raise in Anesthesia and Children, Only, sponsored by University of Saskatchewan. Completed at 1 site in Canada. Open to participants aged 3 Months to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-11-03.
Sponsored by University of Saskatchewan · Not applicable, Interventional, and Supportive care
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.
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.
University of Saskatchewan is the lead sponsor of 237 studies on the registry; 33 are open to participants now.
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Exclusion Criteria:
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.
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.
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.
Time frame: During the intraoperative procedure.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Immediately following successful cannulation in the experimental group.
Plan to share: No — Aggregate results will be presented in manuscript form but no individual participant data (IPD) will be shared.
No publications or documents are linked to this record.
This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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University of Saskatchewan