Peripherally Inserted Central Catheter Insertion TechniqueNCT00565877
The Application of Neck Ultrasound in the Assessment of Peripherally Inserted Central Catheter (PICC) Tip Position
A study testing Ultrasound inspection in people with Peripherally Inserted Central Catheter Insertion Technique, run by University of Chicago at 1 site in United States.
Trial summary
Insertion of peripherally inserted central catheters (PICCs) at the bedside may result in tip malposition. This study was designed to evaluate whether the addition of ultrasound (US) inspection of the ipsilateral neck provides immediate recognition of PICCs in aberrant position facilitating catheter reposition prior… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripherally Inserted Central Catheter Insertion Technique
- What is being tested?
- Ultrasound inspection
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2004to Mar 2006
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (> 18 years old) ordered for a peripherally inserted central catheter insertion
Who cannot join
- patients unable to provide informed consent
- previous peripheral inserted central catheter placement at the institution
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Chicago Medical Center
Chicago, Illinois, 60637
About this study
Official title: A Randomized, Controlled Trial Evaluating Post-Insertion Neck Ultrasound in Peripherally Inserted Central Catheter Procedures
Insertion of peripherally inserted central catheters (PICCs) at the bedside may result in tip malposition. This study was designed to evaluate whether the addition of ultrasound (US) inspection of the ipsilateral neck provides immediate recognition of PICCs in aberrant position facilitating catheter reposition prior to completion of the procedure.
- Being tested
- Ultrasound inspection
- Keywords
- Catheter, Peripherally inserted central catheter, ultrasound, malposition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound inspectionOther
post-PICC insertion Ultrasound inspection of the ipsilateral neck for PICC in a malposition (ipsilateral internal jugular vein)
| Study group | Role | What they receive |
|---|---|---|
| 1 - Neck Ultrasound | Experimental | post-PICC insertion ultrasound inspection of the ipsilateral neck Receives: Other: Ultrasound inspection |
| 2 - Control | No intervention | No post-PICC insertion ultrasound inspection of the ipsilateral neck |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of PICCs in the ipsilateral internal jugular vein malposition as detected by post-procedure chest x-ray
Measured: Same day
Secondary outcomes (1)
Duration of PICC procedure.
Measured: Same day.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2007 (estimated)
- Study startOct 2004
- Primary completionMar 2006
- Study completionMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripherally Inserted Central Catheter Insertion TechniqueStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John P Kress, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00565877
- Sponsor's protocol ID
- 13466A
- Status last verified
- Mar 2014
- First submitted
- 29 Nov 2007
- Last updated
- 18 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled Trial Evaluating Post-Insertion Neck Ultrasound in Peripherally Inserted Central Catheter Procedures
- ClinicalTrials.gov ID
- NCT00565877
- Acronym / sponsor ID
- 13466A
- Keywords
- Catheter, Peripherally inserted central catheter, ultrasound, malposition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- Oct 2004
- Primary completion
- Mar 2006 (actual)
- Study completion
- Mar 2006 (actual)
- First posted
- 30 Nov 2007 (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.
Insertion of peripherally inserted central catheters (PICCs) at the bedside may result in tip malposition. This study was designed to evaluate whether the addition of ultrasound (US) inspection of the ipsilateral neck provides immediate recognition of PICCs in aberrant position facilitating catheter reposition prior to completion of the procedure.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 - Neck Ultrasound | Experimental | Other: Ultrasound inspectionpost-PICC insertion ultrasound inspection of the ipsilateral neck |
| 2 - Control | No intervention | –No post-PICC insertion ultrasound inspection of the ipsilateral neck |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients (> 18 years old) ordered for a peripherally inserted central catheter insertion
Key exclusion criteria (2 listed)
- patients unable to provide informed consent
- previous peripheral inserted central catheter placement at the institution
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 inspectionpost-PICC insertion Ultrasound inspection of the ipsilateral neck for PICC in a malposition (ipsilateral internal jugular vein) | Other | 1 - Neck Ultrasound |
Primary outcome
Rate of PICCs in the ipsilateral internal jugular vein malposition as detected by post-procedure chest x-ray
Time frame: Same day
1 secondary outcome
Duration of PICC procedure.
Time frame: Same day.
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 18 Mar 2014.
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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.
John P Kress, MD principal investigator
University of Chicago
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 inspection in people with Peripherally Inserted Central Catheter Insertion Technique, run by University of Chicago at 1 site in United States.
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 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 18 Mar 2014. 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 United States. 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?
Rate of PICCs in the ipsilateral internal jugular vein malposition as detected by post-procedure chest x-ray (time frame: Same day). 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 18 Mar 2014.