Pediatric AnesthesiaNCT02483507
Ultrasound-guided Peripheral Vascular Access: What Approaches in Paediatrics?
A study testing Ultrasound-guided approach to peripheral vascular access in people with Pediatric Anesthesia and Comparison of 3 Peripheral Vascular Access, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Landmarks used to make a vascular puncture has long been based on the only knowledge of anatomy. This method assumes that the target vessel is in its expected position, permeable (non-thrombosed), and heavy enough to be catheterized. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Pediatric Anesthesia, Comparison of 3 Peripheral Vascular Access
- What is being tested?
- Ultrasound-guided approach to peripheral vascular access
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- May 2014to Jun 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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Child requiring the implementation of a peripherally inserted central catheter or an arterial catheter.
- Child whose general state corresponds to the Physical status score I - IV
- Child whose weight is lower to 30 kg
- Child whose parents will have given their informed consent.
- Child affiliated to a national insurance scheme
Who cannot join
- Child presenting a contraindication to the general anesthesia
- Child whose weight is upper to 30 kg
- Child whose parents did not give their informed consent
Trial locations and contacts
1 site in 1 country.
France1 site
Hôpital Lapeyronie - Département Anesthésie Réanimation A
Montpellier, 34295
About this study
Landmarks used to make a vascular puncture has long been based on the only knowledge of anatomy. This method assumes that the target vessel is in its expected position, permeable (non-thrombosed), and heavy enough to be catheterized. Any variations from these assumptions is likely to cause failures of puncture and complications. The development of ultrasound allowed to "see" the structures to achieve, whether before a puncture or in live for guiding the procedure. Visualization of vessels and adjacent structures has logically resulted in larger cases to a greater security of catheterization, improving the success rate, and decreasing complications. Several positions of the probe can be used to guide a puncture under ultrasound: the transversal approach in short axis, the long axis longitudinal approach and the oblique view approach.The aim of the study was to compare these three different ultrasound-guided approaches to peripheral vascular access in children. All children weighing less than 30 kg that should benefit from the introduction of an arterial catheter or central venous catheter introduced through a peripheral vein are eligible. Patients will be included after parent's and children's information and consent. The choice of the technique used (transverse, longitudinal or oblique approach) is determined by a randomization table.The puncture procedure is performed according to the usual protocols of the paediatric anesthesia unit of the investigators, under ultrasound guidance in a sterile manner. No time limit is required for the identification and implementation of the catheter. The position of the probe is dictated by the result of randomization and the Seldinger technique is used for the establishment of the catheter. Beyond two unsuccessful attempts, the procedure is considered as a failure. The anesthetist then uses the alternative technique of his choice. All anesthetists participating in this study exercised their main activity in the Montpellier University Hospital pediatric anesthesia unit. The laying of ultrasound-guided peripherally inserted central catheter and arterial catheter is part of the current activity of the unit.
- Being tested
- Ultrasound-guided approach to peripheral vascular access
- Keywords
- Ultrasound guidance, Vascular access, Pediatric anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-guided approach to peripheral vascular accessOther
the transversal approach is in short axis with an out of plane puncture, the longitudinal approach is in transversal axis with an in plane puncture, the oblique view approach is in obliques axis with an in plane puncture
| Study group | Role | What they receive |
|---|---|---|
| Group T: transversal | Active comparator | Implementation of the vascular catheter with transversal approach under ultrasound guidance Receives: Other: Ultrasound-guided approach to peripheral vascular access |
| Group L: longitudinal | Active comparator | Implementation of the vascular catheter with longitudinal approach under ultrasound guidance Receives: Other: Ultrasound-guided approach to peripheral vascular access |
| Group O: oblique | Active comparator | Implementation of the vascular catheter with oblique approach under ultrasound guidance Receives: Other: Ultrasound-guided approach to peripheral vascular access |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate
The success of the procedure is defined by the success of the puncture to the first or the second attempt.
Measured: one hour
Secondary outcomes (3)
The number of attempts
the number of attempts is defined by the number of puncture performed
Measured: one hour
The duration of the puncture procedure
the duration of the puncture procedure is defined for the puncture until objectivization of a blood reflux.
Measured: on hour
The operator satisfaction
Level of satisfaction of the operators according to the technique used
Measured: one hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2015 (estimated)
- Study startMay 2014
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric AnesthesiaStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chrystelle CS SOLA, MD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02483507
- Sponsor's protocol ID
- 9420
- Other IDs
- 2013-A01587-38
- Status last verified
- Jun 2015
- First submitted
- 15 Jun 2015
- Last updated
- 20 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-guided Peripheral Vascular Access: What Approaches in Paediatrics?
- ClinicalTrials.gov ID
- NCT02483507
- Acronym / sponsor ID
- 9420
- Keywords
- Ultrasound guidance, Vascular access, Pediatric anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 29 Jun 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.
Landmarks used to make a vascular puncture has long been based on the only knowledge of anatomy. This method assumes that the target vessel is in its expected position, permeable (non-thrombosed), and heavy enough to be catheterized. Any variations from these assumptions is likely to cause failures of puncture and complications. The development of ultrasound allowed to "see" the structures to achieve, whether before a puncture or in live for guiding the procedure. Visualization of vessels and adjacent structures has logically resulted in larger cases to a greater security of catheterization, improving the success rate, and decreasing complications. Several positions of the probe can be used to guide a puncture under ultrasound: the transversal approach in short axis, the long axis longitudinal approach and the oblique view approach.The aim of the study was to compare these three different ultrasound-guided approaches to peripheral vascular access in children. All children weighing less than 30 kg that should benefit from the introduction of an arterial catheter or central venous catheter introduced through a peripheral vein are eligible. Patients will be included after parent's and children's information and consent. The choice of the technique used (transverse, longitudinal or oblique approach) is determined by a randomization table.The puncture procedure is performed according to the usual protocols of the paediatric anesthesia unit of the investigators, under ultrasound guidance in a sterile manner. No time limit is required for the identification and implementation of the catheter. The position of the probe is dictated by the result of randomization and the Seldinger technique is used for the establishment of the catheter. Beyond two unsuccessful attempts, the procedure is considered as a failure. The anesthetist then uses the alternative technique of his choice. All anesthetists participating in this study exercised their main activity in the Montpellier University Hospital pediatric anesthesia unit. The laying of ultrasound-guided peripherally inserted central catheter and arterial catheter is part of the current activity of the unit.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group T: transversal | Active comparator | Other: Ultrasound-guided approach to peripheral vascular accessImplementation of the vascular catheter with transversal approach under ultrasound guidance |
| Group L: longitudinal | Active comparator | Other: Ultrasound-guided approach to peripheral vascular accessImplementation of the vascular catheter with longitudinal approach under ultrasound guidance |
| Group O: oblique | Active comparator | Other: Ultrasound-guided approach to peripheral vascular accessImplementation of the vascular catheter with oblique approach under ultrasound guidance |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Child requiring the implementation of a peripherally inserted central catheter or an arterial catheter.
- Child whose general state corresponds to the Physical status score I - IV
- Child whose weight is lower to 30 kg
- Child whose parents will have given their informed consent.
- Child affiliated to a national insurance scheme
Key exclusion criteria (3 listed)
- Child presenting a contraindication to the general anesthesia
- Child whose weight is upper to 30 kg
- Child whose parents did not give their informed consent
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 |
|---|---|---|
| Ultrasound-guided approach to peripheral vascular accessthe transversal approach is in short axis with an out of plane puncture, the longitudinal approach is in transversal axis with an in plane puncture, the oblique view approach is in obliques axis with an in plane puncture | Other | Group L: longitudinal, Group O: oblique, Group T: transversal |
Primary outcome
Success rate
Time frame: one hour
The success of the procedure is defined by the success of the puncture to the first or the second attempt.
3 secondary outcomes
The number of attempts
Time frame: one hour
The duration of the puncture procedure
Time frame: on hour
The operator satisfaction
Time frame: one hour
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 20 Feb 2018.
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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.
Chrystelle CS SOLA, MD principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound-guided approach to peripheral vascular access in people with Pediatric Anesthesia and Comparison of 3 Peripheral Vascular Access, run by University Hospital, Montpellier at 1 site in France.
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 5 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 20 Feb 2018. 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 France. 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?
Success rate (time frame: one hour). 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 20 Feb 2018.