Intravenous Puncture AssertivityNCT00930254
Peripheral Intravenous Puncture Guided by Vascular Ultrasound
A study testing IV puncture guided by ultrasound in people with Intravenous Puncture Assertivity and Intravenous Puncture Guided by Vascular Ultrasound, run by Federal University of São Paulo at 1 site in Brazil.
Trial summary
This research, aimed to verify whether the use of vascular ultrasonography (VUS) could lead to better results in the peripheral venous access implementation in children. Objectives: To compare, regardless of the number of venous puncture attempts, peripheral venous access obtained in children, according to VUS use or… Read more about this study
- Who is it for?
- Ages 1 day to 18 years
- Conditions the study is for
- Intravenous Puncture Assertivity, Intravenous Puncture Guided by Vascular Ultrasound, Intravenous Therapy Complications
- What is being tested?
- IV puncture guided by ultrasound
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 335 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2007to Jul 2008
- 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 1 day to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- children submitted to intravenous therapy
Who cannot join
- adults
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Vascular Ultrasound During the Use of Peripheral Intravenous Catheters in Children: A Clinical, Randomized and Controlled Trial.
This research, aimed to verify whether the use of vascular ultrasonography (VUS) could lead to better results in the peripheral venous access implementation in children.
Objectives: To compare, regardless of the number of venous puncture attempts, peripheral venous access obtained in children, according to VUS use or traditional method for peripheral intravenous catheter (PIC) insertion; assertiveness in the use of PIC in children, defined as success in the first attempt of puncture and PIC withdrawal according to release of treatment, related to VUS or traditional method and to describe the influence of VUS on PIC dwell time and development of local complications related to the use of intravenous therapy in children.
Read the detailed description
Clinical, randomized and controlled trial, conducted in a pediatric surgery ward of a university hospital in São Paulo. Data collection occurred from February 26th, 2007 to July 07th, 2008, after ethical merits of research approval. The sample comprised 382 venous puncture randomly allocated in the experimental group (EG), venous puncture guided by VUS, or in the control group (CG), traditional method of venous puncture. Variables related to children, intravenous therapy and professional characterization were collected. The dependent variables included the obtainment of peripheral venous access, the assertiveness, the catheter dwell time and the occurrence of local complications. For the statistical analysis were applied the Pearson Chi-square, Fisher's Exact, Generalization of Fisher's exact, Mann-Whitney, Likelihood Ratio and Prevalence Ratio (significance level of 5%).
- Conditions
- Intravenous Puncture Assertivity, Intravenous Puncture Guided by Vascular Ultrasound, Intravenous Therapy Complications
- Being tested
- IV puncture guided by ultrasound
- Keywords
- pediatric nursing, peripheral catheterization, ultrasonics, intravenous infusions
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
Also called vascular ultrasound
Comparisons between traditional and ultrasound group
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound | Experimental | Vascular puncture guided by vascular ultrasound Receives: Procedure: IV puncture guided by ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Venous access obtainment occurred in the two studied groups, with marginally significant statistical difference. The success in the first attempt of puncture was statistically similar.
Measured: 1 year and 5 months
Secondary outcomes (1)
The median of catheters dwell time was similar in the control group and experimental group. Infiltration had a different distribution between groups, been more frequent in the Experimental group.
Measured: 1 year and 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2009 (estimated)
- Study startFeb 2007
- Primary completionNov 2007
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intravenous Puncture AssertivityStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 335 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Investigators
- Ariane FM Avelar, Master, Principal investigator, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00930254
- Sponsor's protocol ID
- USV01
- Other IDs
- 0402/06
- Status last verified
- Jun 2009
- First submitted
- 25 Jun 2009
- Last updated
- 30 Jun 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Avelar AF, Peterlini MA, da Pedreira ML. [Assertiveness and peripheral intravenous catheters dwell time with ultrasonography-guided insertion in children and adolescents]. Rev Esc Enferm USP. 2013 Jun;47(3):539-46. doi: 10.1590/s0080-623420130000300003. Portuguese.
PubMed 24601127
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vascular Ultrasound During the Use of Peripheral Intravenous Catheters in Children: A Clinical, Randomized and Controlled Trial.
- ClinicalTrials.gov ID
- NCT00930254
- Acronym / sponsor ID
- USV01
- Conditions
- Intravenous Puncture Assertivity, Intravenous Puncture Guided by Vascular Ultrasound, Intravenous Therapy Complications
- Keywords
- pediatric nursing, peripheral catheterization, ultrasonics, intravenous infusions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 335 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Study start
- Feb 2007
- Primary completion
- Nov 2007 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 30 Jun 2009 (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.
This research, aimed to verify whether the use of vascular ultrasonography (VUS) could lead to better results in the peripheral venous access implementation in children.
Objectives: To compare, regardless of the number of venous puncture attempts, peripheral venous access obtained in children, according to VUS use or traditional method for peripheral intravenous catheter (PIC) insertion; assertiveness in the use of PIC in children, defined as success in the first attempt of puncture and PIC withdrawal according to release of treatment, related to VUS or traditional method and to describe the influence of VUS on PIC dwell time and development of local complications related to the use of intravenous therapy in children.
Detailed description
Clinical, randomized and controlled trial, conducted in a pediatric surgery ward of a university hospital in São Paulo. Data collection occurred from February 26th, 2007 to July 07th, 2008, after ethical merits of research approval. The sample comprised 382 venous puncture randomly allocated in the experimental group (EG), venous puncture guided by VUS, or in the control group (CG), traditional method of venous puncture. Variables related to children, intravenous therapy and professional characterization were collected. The dependent variables included the obtainment of peripheral venous access, the assertiveness, the catheter dwell time and the occurrence of local complications. For the statistical analysis were applied the Pearson Chi-square, Fisher's Exact, Generalization of Fisher's exact, Mann-Whitney, Likelihood Ratio and Prevalence Ratio (significance level of 5%).
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ultrasound | Experimental | Procedure: IV puncture guided by ultrasoundVascular puncture guided by vascular ultrasound |
Who may qualify
- Ages
- 1 day to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- children submitted to intravenous therapy
Key exclusion criteria (1 listed)
- adults
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 ultrasoundAlso: vascular ultrasoundComparisons between traditional and ultrasound group | Procedure or surgery | Ultrasound |
Primary outcome
Venous access obtainment occurred in the two studied groups, with marginally significant statistical difference. The success in the first attempt of puncture was statistically similar.
Time frame: 1 year and 5 months
1 secondary outcome
The median of catheters dwell time was similar in the control group and experimental group. Infiltration had a different distribution between groups, been more frequent in the Experimental group.
Time frame: 1 year and 5 months
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 30 Jun 2009.
- Derived from this study: PubMed 24601127Avelar AF, Peterlini MA, da Pedreira ML. [Assertiveness and peripheral intravenous catheters dwell time with ultrasonography-guided insertion in children and adolescents]. Rev Esc Enferm USP. 2013 Jun;47(3):539-46. doi: 10.1590/s0080-623420130000300003. Portuguese.
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.
Ariane FM Avelar, Master principal investigator
Federal University of São Paulo
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 Intravenous Puncture Assertivity and Intravenous Puncture Guided by Vascular Ultrasound, run by Federal University of São Paulo at 1 site in Brazil.
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 30 Jun 2009. 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 Brazil. 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?
Venous access obtainment occurred in the two studied groups, with marginally significant statistical difference. The success in the first attempt of puncture was statistically similar. (time frame: 1 year and 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00930254, which also lists 1 linked publication.
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 30 Jun 2009.