Cardiovascular InfectionsNCT01279642
Placement of Peripherally Inserted Central Venous Catheters (PICC) in Children Guided by Ultrasound
A study testing ultrasound and traditional puncture in people with Cardiovascular Infections and Peripheral Vascular Disease, run by Federal University of São Paulo at 1 site in Brazil.
Trial summary
Aimed to compare the success in the peripheral intravenous puncture (PIP), progression and placement of PICC in children, according to the use of Doppler vascular ultrasound (DVUS) or traditional method; to identify the influence of the DUVS in the time expended to PICC placement. Read more about this study
- Who is it for?
- Ages 1 month to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Infections, Peripheral Vascular Disease
- What is being tested?
- ultrasound and traditional puncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2008to Aug 2009
- 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 month to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Children in IV Therapy for 7 days or more;
- Peripheral venous vessels indicated to PICC
Who cannot join
- Patient or family refuse to consent in PICC insertion.
- Patient or family refuse to participate in the research.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Use of Doppler Vascular Ultrasound by Nurses During the Placement of Peripherally Inserted Central Venous Catheters in Children: Clinical, Randomized and Controlled Trial.
Aimed to compare the success in the peripheral intravenous puncture (PIP), progression and placement of PICC in children, according to the use of Doppler vascular ultrasound (DVUS) or traditional method; to identify the influence of the DUVS in the time expended to PICC placement. Methods: Clinical, randomized and controlled trial conducted after ethical merits of research endorsement and the obtaining of consent for those responsible for the children. The sample, calculated in 42 PICC to obtain a power of 0,85, was distributed randomly into two groups, experimental group (EG) and controlled group (CG). To the statistical analyzes Pearson Chi-square, Fisher's Exact Tests, Generalization of Fischer's Exact and Mann-Whitney tests was applied (5%). Of the 42 catheters, 21 (50.0%) were implemented in EG and 21 (50.0%) in CG. The PIP was obtained in the first attempt in 90.5% of the punctures of the EG and in 47.6% of the GC, (p=0.003). PICC were implanted successfully in 18 (85.7%) children of GE and 11 (61.1%) of CG (p = 0.019). The median of the time spent to the procedure was significantly higher (p=0.001) in CG (50 minutes) when compared to EG (median 20 minutes).
Read the detailed description
Introduction: Peripherally inserted central venous catheters (PICC) are increasingly being used to intravenous therapy in a wide variety of adults and pediatrics patients. Children may have characteristics that could compromise the assertiveness during the catheter placement, even for the more experienced and qualified professionals. In order to search for methods that could lead to the nursing practice innovation seeking for better results in the placement of PICC, this study was designed to analyze the use of Doppler vascular ultrasound (DVUS) to PICC insertion performed by nurses. Objective: To compare the success in the peripheral intravenous puncture (PIP), progression and placement of PICC in children, according to the use of DVUS or traditional method; to identify the influence of the DUVS in the time expended to the placement of PICC in children. Methods: Clinical, randomized and controlled trial conducted in a pediatric surgery ward of a university hospital, from August 17th, 2007 to August 19th, 2008, after ethical merits of research endorsement and the obtaining of consent for those responsible for the children. The sample, calculated in 42 PICC to obtain a power of 0,85, was distributed randomly into two groups, experimental group (EG) and controlled group (CG). The dependent variables were: the success in the PIP, catheter progression and placement. Variables related to children and IV therapy was investigated. To the statistical analyzes Pearson Chi-square, Fisher's Exact Tests, Generalization of Fischer's Exact and Mann-Whitney tests was applied (significance level of 5%). Results: Of the 42 catheters, 21 (50.0%) were implemented in EG and 21 (50.0%) in CG. The PIP was obtained in the first attempt in 90.5% of the punctures of the EG and in 47.6% of the GC, (p=0.003)and the punctures were accomplished to catheter insertion, despite the number of attempts in 76.5% of EG and 41.7% in GC (p = 0.001). The successful to PICC progression was marginally significant result (p=0.069), 69.2% in EG and 44.0% in CG. PICC were implanted successfully in 18 (85.7%) children of GE and 11 (61.1%) of CG (p = 0.019). The median of the time spent to the procedure was significantly higher (p=0.001) in CG (50 minutes) when compared to EG (median 20 minutes). Conclusion: The results obtained lead to the conclusion that the use of USVD to the implementation of the PICC in children promoted greater success in the PIP and in PICC placement, reducing of the time spent to the procedure, but no significant influence was observed regarding the catheter progression.
- Being tested
- ultrasound, traditional puncture
- Keywords
- Catheterization, Peripheral, Ultrasonography, Interventional, Nursing, Pediatric
- Medical subject headings
- Cardiovascular Infections, Peripheral Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasoundDevice
Also called vascular doppler ultrasound, interventional ultrasound, vascualr access
Doppler vascular ultrasound guidance to PICC insertion in children -
traditional punctureOther
Also called vascular access
traditional approach of PICC insertion by visualization and inspection of insertion site
| Study group | Role | What they receive |
|---|---|---|
| ultrasound | Experimental | Use of ultrasound to PICC placement Receives: Device: ultrasound |
| Control group | Active comparator | PICC placement by inspection and visualization of site Receives: Other: traditional puncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success in PICC placement.
The PICC was placed in the first attempt in 90.5% of the punctures of the ultrasound group and in 47.6% of the control group (p=0.003
Measured: 1 year
Secondary outcomes (1)
Time spent to PICC placement
The median time spent to the procedure was significantly higher (p=0.001) in control group (50 minutes) when compared to ultrasound group (median 20 minutes).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2011 (estimated)
- Study startAug 2008
- Primary completionAug 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular InfectionsStudies 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
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Investigators
- Mavilde LG Pedreira, PhD, Principal investigator, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01279642
- Sponsor's protocol ID
- 1967/06
- Other IDs
- CNPq Grant nº. 476295/2004-1.
- Status last verified
- Jul 2010
- First submitted
- 18 Jan 2011
- Last updated
- 19 Jan 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Doppler Vascular Ultrasound by Nurses During the Placement of Peripherally Inserted Central Venous Catheters in Children: Clinical, Randomized and Controlled Trial.
- ClinicalTrials.gov ID
- NCT01279642
- Acronym / sponsor ID
- 1967/06
- Keywords
- Catheterization, Peripheral, Ultrasonography, Interventional, Nursing, Pediatric
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 19 Jan 2011 (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.
Aimed to compare the success in the peripheral intravenous puncture (PIP), progression and placement of PICC in children, according to the use of Doppler vascular ultrasound (DVUS) or traditional method; to identify the influence of the DUVS in the time expended to PICC placement. Methods: Clinical, randomized and controlled trial conducted after ethical merits of research endorsement and the obtaining of consent for those responsible for the children. The sample, calculated in 42 PICC to obtain a power of 0,85, was distributed randomly into two groups, experimental group (EG) and controlled group (CG). To the statistical analyzes Pearson Chi-square, Fisher's Exact Tests, Generalization of Fischer's Exact and Mann-Whitney tests was applied (5%). Of the 42 catheters, 21 (50.0%) were implemented in EG and 21 (50.0%) in CG. The PIP was obtained in the first attempt in 90.5% of the punctures of the EG and in 47.6% of the GC, (p=0.003). PICC were implanted successfully in 18 (85.7%) children of GE and 11 (61.1%) of CG (p = 0.019). The median of the time spent to the procedure was significantly higher (p=0.001) in CG (50 minutes) when compared to EG (median 20 minutes).
Detailed description
Introduction: Peripherally inserted central venous catheters (PICC) are increasingly being used to intravenous therapy in a wide variety of adults and pediatrics patients. Children may have characteristics that could compromise the assertiveness during the catheter placement, even for the more experienced and qualified professionals. In order to search for methods that could lead to the nursing practice innovation seeking for better results in the placement of PICC, this study was designed to analyze the use of Doppler vascular ultrasound (DVUS) to PICC insertion performed by nurses. Objective: To compare the success in the peripheral intravenous puncture (PIP), progression and placement of PICC in children, according to the use of DVUS or traditional method; to identify the influence of the DUVS in the time expended to the placement of PICC in children. Methods: Clinical, randomized and controlled trial conducted in a pediatric surgery ward of a university hospital, from August 17th, 2007 to August 19th, 2008, after ethical merits of research endorsement and the obtaining of consent for those responsible for the children. The sample, calculated in 42 PICC to obtain a power of 0,85, was distributed randomly into two groups, experimental group (EG) and controlled group (CG). The dependent variables were: the success in the PIP, catheter progression and placement. Variables related to children and IV therapy was investigated. To the statistical analyzes Pearson Chi-square, Fisher's Exact Tests, Generalization of Fischer's Exact and Mann-Whitney tests was applied (significance level of 5%). Results: Of the 42 catheters, 21 (50.0%) were implemented in EG and 21 (50.0%) in CG. The PIP was obtained in the first attempt in 90.5% of the punctures of the EG and in 47.6% of the GC, (p=0.003)and the punctures were accomplished to catheter insertion, despite the number of attempts in 76.5% of EG and 41.7% in GC (p = 0.001). The successful to PICC progression was marginally significant result (p=0.069), 69.2% in EG and 44.0% in CG. PICC were implanted successfully in 18 (85.7%) children of GE and 11 (61.1%) of CG (p = 0.019). The median of the time spent to the procedure was significantly higher (p=0.001) in CG (50 minutes) when compared to EG (median 20 minutes). Conclusion: The results obtained lead to the conclusion that the use of USVD to the implementation of the PICC in children promoted greater success in the PIP and in PICC placement, reducing of the time spent to the procedure, but no significant influence was observed regarding the catheter progression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ultrasound | Experimental | Device: ultrasoundUse of ultrasound to PICC placement |
| Control group | Active comparator | Other: traditional puncturePICC placement by inspection and visualization of site |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Children in IV Therapy for 7 days or more;
- Peripheral venous vessels indicated to PICC
Key exclusion criteria (2 listed)
- Patient or family refuse to consent in PICC insertion.
- Patient or family refuse to participate in the research.
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 |
|---|---|---|
| ultrasoundAlso: vascular doppler ultrasound, interventional ultrasound, vascualr accessDoppler vascular ultrasound guidance to PICC insertion in children - | Device | ultrasound |
| traditional punctureAlso: vascular accesstraditional approach of PICC insertion by visualization and inspection of insertion site | Other | Control group |
Primary outcome
Success in PICC placement.
Time frame: 1 year
The PICC was placed in the first attempt in 90.5% of the punctures of the ultrasound group and in 47.6% of the control group (p=0.003
1 secondary outcome
Time spent to PICC placement
Time frame: 1 year
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 19 Jan 2011.
Related trials for Cardiovascular Infections
Not yet recruitingObservational study
Pilot Study on the Effectiveness and Safety of OPTILENE® SILVER MESH ELASTIC in Prevention of Surgical Site Infection (SSI) and Incisional Hernia (IH)
Abdominal Aortic Aneurysm, Morbid Obesity
RecruitingObservational study
Cardiovascular Disease Progression in Survivors of Community Acquired Pneumonia and Lung Infection by Covid-19.
Pneumonia, Community-Acquired, COVID-19 Pneumonia
RecruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
Active, not recruitingObservational study
The CoPenHagen PREeClampsia and cardIOvascUlar diSease Study
Pre-Eclampsia, Atherosclerosis
Not yet recruitingObservational study
Ultrasound-Calibrated Pulse Contour Cardiac Output Monitoring: Value and Accuracy in Hemodynamic Care
Sepsis, Circulatory Instability
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.
Mavilde LG Pedreira, PhD 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 ultrasound and traditional puncture in people with Cardiovascular Infections and Peripheral Vascular Disease, 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 2 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: finished, as of the sponsor's last update on 19 Jan 2011. 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?
Success in PICC placement. (time frame: 1 year). 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 19 Jan 2011.