UltrasonographyNCT02556541
Ultrasound-guided Peripheral Vascular Access in Children
A study testing IV puncture guided by ultrasound in people with Ultrasonography and Vascular Access Devices, run by University of Aarhus at 1 site in Denmark.
Trial summary
The purpose of this investigation is to conduct a randomized, patient-blinded prospective controlled trial comparing peripheral intravenous cannulation in children done by: 1. Conventional landmark cannulation where the intravenous cannulation is done by direct visual guidance or palpation or a combination thereof. 2. Read more about this study
- Who is it for?
- Ages Up to 3 years
- Conditions the study is for
- Ultrasonography, Vascular Access Devices, Pediatrics
- What is being tested?
- IV puncture guided by ultrasound
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2015to Aug 2016
- 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 Up to 3 years
- All sexes
- Child
Who may be able to join
- Requirement for anaesthesia before MRI or operation.
- Routine need of peripheral intravenous cannulation.
- Age 0- 3 years at the date of MR scan
Who cannot join
- Lack of consent
- Emergency patients needing immediate operation or scan.
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Department of Anaesthesiology and Intensive Care
Aarhus, 8200
Erik Sloth, professor, phd, MD, 78 45 10 28, sloth@dadlnet.dk
About this study
Official title: Ultrasound-guided Peripheral Vascular Access in Children - a Single- Blind, Randomized, Cross-over Trial
The purpose of this investigation is to conduct a randomized, patient-blinded prospective controlled trial comparing peripheral intravenous cannulation in children done by:
- Conventional landmark cannulation where the intravenous cannulation is done by direct visual guidance or palpation or a combination thereof.
- Ultrasound guided cannulation by means of DNTP.
The investigators hypothesize that with ultrasound-guided peripheral intravenous cannulation the first-attempt success rate will be significantly higher than by the conventional landmark cannulation technique.
- Conditions
- Ultrasonography, Vascular Access Devices, Pediatrics
- Being tested
- IV puncture guided by ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IV puncture guided by ultrasoundProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
First attempt success
Succes rate of first attempt cannulation for ultrasound and traditional method will be compared.
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionAug 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UltrasonographyStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- 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
- Intervention model
- Crossover
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02556541
- Sponsor's protocol ID
- 1-10-72-94-15
- Status last verified
- Apr 2015
- First submitted
- 15 Sep 2015
- Last updated
- 7 Mar 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-guided Peripheral Vascular Access in Children - a Single- Blind, Randomized, Cross-over Trial
- ClinicalTrials.gov ID
- NCT02556541
- Acronym / sponsor ID
- 1-10-72-94-15
- Conditions
- Ultrasonography, Vascular Access Devices, Pediatrics
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Aug 2016 (estimated)
- First posted
- 22 Sep 2015 (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 purpose of this investigation is to conduct a randomized, patient-blinded prospective controlled trial comparing peripheral intravenous cannulation in children done by:
- Conventional landmark cannulation where the intravenous cannulation is done by direct visual guidance or palpation or a combination thereof.
- Ultrasound guided cannulation by means of DNTP.
The investigators hypothesize that with ultrasound-guided peripheral intravenous cannulation the first-attempt success rate will be significantly higher than by the conventional landmark cannulation technique.
Study design
- Primary purpose
- Supportive care
- Intervention model
- Crossover
Who may qualify
- Ages
- Up to 3 years
- Sex
- All
- Age groups
- Child
Key inclusion criteria (3 listed)
- Requirement for anaesthesia before MRI or operation.
- Routine need of peripheral intravenous cannulation.
- Age 0- 3 years at the date of MR scan
Key exclusion criteria (2 listed)
- Lack of consent
- Emergency patients needing immediate operation or scan.
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 |
|---|---|---|
| IV puncture guided by ultrasound | Procedure or surgery | – |
Primary outcome
First attempt success
Time frame: Intraoperative
Succes rate of first attempt cannulation for ultrasound and traditional method will be compared.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2016.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IV puncture guided by ultrasound in people with Ultrasonography and Vascular Access Devices, run by University of Aarhus at 1 site in Denmark.
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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 7 Mar 2016. 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 Denmark. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nigopan Gopalasingam (+45 31535950, 20103907@post.au.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
First attempt success (time frame: Intraoperative). 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 7 Mar 2016.