AnesthesiaNCT05298137
Passive Leg Raise for Pediatric Peripheral IV Placement
A study testing Passive Leg Raise in people with Anesthesia and Children, Only, run by University of Saskatchewan at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 3 months to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia, Children, Only
- What is being tested?
- Passive Leg Raise
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 234 participants
- Where
- 1 siteCanada
- Study dates
- 10 May 2022to 30 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 months to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children ages 3 months to 17 years.
- American Society of Anesthesiology (ASA) physical status 1-3 scheduled for elective surgical procedures under general anesthesia.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Anesthesia, Children, Only
- Being tested
- Passive Leg Raise
- Keywords
- Pediatrics, Anesthesiology, Cannula, Anesthesia, Intravenous, Catheterization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Passive Leg RaiseProcedure or surgery
A passive leg raise (PLR) is defined as raising a patient's legs to a 45-degree angle at the hip while supine.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Passive Leg Raise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During the intraoperative procedure.
Secondary outcomes (4)
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.
Measured: 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: 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.
Measured: 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.
Measured: Immediately following successful cannulation in the experimental group.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2022
- Study start10 May 2022
- Primary completion30 Jul 2022
- Study completion30 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The investigators propose a prospective, parallel group, open-label randomized controlled trial.
- Masking
- None (open label)
- Enrolment
- 234 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Saskatchewan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonathan Gamble, University of Saskatchewan
- Investigators
- Jonathan J Gamble, MD, Principal investigator, Department of Anesthesiology, University of Saskatchewan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05298137
- Sponsor's protocol ID
- Bio #3221
- Status last verified
- Nov 2022
- First submitted
- 6 Mar 2022
- Last updated
- 3 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Aggregate results will be presented in manuscript form but no individual participant data (IPD) will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Passive Leg Raise for Pediatric Peripheral IV Placement
- ClinicalTrials.gov ID
- NCT05298137
- Acronym / sponsor ID
- Bio #3221
- Conditions
- Anesthesia, Children, Only
- Keywords
- Pediatrics, Anesthesiology, Cannula, Anesthesia, Intravenous, Catheterization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 234 participants (actual)
- Lead sponsor
- University of SaskatchewanUniversity, hospital or other
- Study start
- 10 May 2022 (actual)
- Primary completion
- 30 Jul 2022 (actual)
- Study completion
- 30 Jul 2022 (actual)
- First posted
- 28 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The investigators propose a prospective, parallel group, open-label randomized controlled trial.
| Arm | Type | Receives |
|---|---|---|
| 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 | Procedure: Passive Leg RaisePatients 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. |
Who may qualify
- Ages
- 3 months to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children ages 3 months to 17 years.
- American Society of Anesthesiology (ASA) physical status 1-3 scheduled for elective surgical procedures under general anesthesia.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Passive Leg RaiseA passive leg raise (PLR) is defined as raising a patient's legs to a 45-degree angle at the hip while supine. | Procedure or surgery | IV Cannulation With Passive Leg Raise |
Primary outcome
The number of attempts to successful catheterization.
Time frame: During the intraoperative procedure.
The study's primary outcome (number of peripheral IV attempts) will be analyzed using a Chi-square test.
4 secondary outcomes
The mean change in peripheral vein diameter following passive leg raise, assessed on ultrasonography.
Time frame: During the intraoperative procedure.
Time from skin puncture to the confirmation of a functioning peripheral line.
Time frame: Measured intraoperatively, an expected estimated average of 2 minutes.
Provider perception of PLR on vein visualization.
Time frame: Immediately following successful cannulation in the experimental group.
Provider perception of PLR on vein palpation.
Time frame: Immediately following successful cannulation in the experimental group.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2022.
- Individual participant dataSharing planned: No. Aggregate results will be presented in manuscript form but no individual participant data (IPD) will be shared.
Related trials for Anesthesia
Recruiting
NOL Guided Analgesia During Elective Laparoscopic Surgery Under General Anesthesia
Intraoperative Analgesia
RecruitingObservational study
Prevalence of Pain During Cesarean Section
Cesarean Birth
RecruitingObservational study
Pulse Wave Transit Time After Infraclavicular Block
Infraclavicular Brachial Plexus Block
RecruitingPhase 4
Propofol-Ketamine Versus Sevoflurane for Laryngeal Mask Anesthesia in Pediatric Cardiac Catheterization
Propofol, Ketamine
Recruiting
Lateral QL Block vs Intrathecal Morphine for Cesarean Section
Anesthesia, Postoperative Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan J Gamble, MD principal investigator
Department of Anesthesiology, University of Saskatchewan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Passive Leg Raise in people with Anesthesia and Children, Only, run by University of Saskatchewan at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of attempts to successful catheterization. (time frame: During the intraoperative procedure.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2022.