Intravenous AccessNCT03029754
Effect of Passive Leg Raise for Pediatric Peripheral IV Placement
A study testing Passive leg raise in people with Intravenous Access, run by University of Saskatchewan at 1 site in Canada.
Trial summary
The investigators wish to determine whether passive leg raise allows for easier peripheral vascular access in the pediatric population. The investigators hypothesize that pediatric anesthesiologists will have higher rates of successful intravenous catheterization in children where a passive leg raise is employed. Read more about this study
- Who is it for?
- Ages 3 months to 14 years
- Conditions the study is for
- Intravenous Access
- 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
- 87 participants
- Where
- 1 siteCanada
- Study dates
- 17 May 2017to 14 Dec 2017
- 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 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- pediatric participants undergoing dental procedures under general anesthesia
Who cannot join
- Children who already have adequate IV access
Trial locations and contacts
1 site in 1 country.
About this study
The investigators wish to determine whether passive leg raise allows for easier peripheral vascular access in the pediatric population. The investigators hypothesize that pediatric anesthesiologists will have higher rates of successful intravenous catheterization in children where a passive leg raise is employed.
- Conditions
- Intravenous Access
- Being tested
- Passive leg raise
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 baseline vein diameter will be obtained using ultrasound by the sub-investigator. Then a nurse will raise the child's legs using a bolster while a second measurement of the child's vein diameter is recorded by the sub-investigator. The anesthesiologist will then place the IV and rate the degree of difficulty encountered.
| Study group | Role | What they receive |
|---|---|---|
| Passive leg raise | Experimental | Participant's legs will be raised with a bolster prior to IV insertion. Receives: Procedure: Passive leg raise |
| No leg raise | No intervention | Participants will lie flat prior to IV insertion. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in peripheral vein diameter
Change between vein diameter at baseline and following group allocation.
Measured: at 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2017 (estimated)
- Study start17 May 2017
- Primary completion14 Dec 2017
- Study completion14 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intravenous AccessStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 87 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 Gamble, MD, Principal investigator, University of Saskatchewan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03029754
- Sponsor's protocol ID
- Bio 16-331
- Status last verified
- Jan 2019
- First submitted
- 19 Jan 2017
- Last updated
- 9 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Passive Leg Raise for Pediatric Peripheral IV Placement
- ClinicalTrials.gov ID
- NCT03029754
- Acronym / sponsor ID
- Bio 16-331
- Conditions
- Intravenous Access
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- University of SaskatchewanUniversity, hospital or other
- Study start
- 17 May 2017 (actual)
- Primary completion
- 14 Dec 2017 (actual)
- Study completion
- 14 Dec 2017 (actual)
- First posted
- 24 Jan 2017 (estimated)
- 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 wish to determine whether passive leg raise allows for easier peripheral vascular access in the pediatric population. The investigators hypothesize that pediatric anesthesiologists will have higher rates of successful intravenous catheterization in children where a passive leg raise is employed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Passive leg raise | Experimental | Procedure: Passive leg raiseParticipant's legs will be raised with a bolster prior to IV insertion. |
| No leg raise | No intervention | –Participants will lie flat prior to IV insertion. |
Who may qualify
- Ages
- 3 months to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- pediatric participants undergoing dental procedures under general anesthesia
Key exclusion criteria (1 listed)
- Children who already have adequate IV access
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 baseline vein diameter will be obtained using ultrasound by the sub-investigator. Then a nurse will raise the child's legs using a bolster while a second measurement of the child's vein diameter is recorded by the sub-investigator. The anesthesiologist will then place the IV and rate the degree of difficulty encountered. | Procedure or surgery | Passive leg raise |
Primary outcome
Mean change in peripheral vein diameter
Time frame: at 5 minutes
Change between vein diameter at baseline and following group allocation.
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 9 Jan 2019.
- Individual participant dataSharing planned: No
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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 Gamble, MD principal investigator
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 Intravenous Access, 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 1 inclusion and 1 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 9 Jan 2019. 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?
Mean change in peripheral vein diameter (time frame: at 5 minutes). 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 9 Jan 2019.