Primary Focus: Adult Subjects Who Require PICC PlacementNCT00742053
Electrocardiogram (ECG) Guided Peripherally Inserted Central Catheter (PICC) Placement
A study testing ECG-guided PICC placement in people with Primary Focus: Adult Subjects Who Require PICC Placement, run by C. R. Bard at 1 site in United States.
Trial summary
This study is designed to obtain information for design purposes on use of an ECG guided monitoring system to aid in the correct placement of PICC lines. There is no formal study hypothesis. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Primary Focus: Adult Subjects Who Require PICC Placement
- What is being tested?
- ECG-guided PICC placement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2008to Mar 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Require Power PICC placement as standard care
- Signed informed consent
Who cannot join
- Has an intracardiac device
- Does not have normal sinus rhythm
- Has known abnormality of central venous system
- Plasma creatinine >=1.5 mg/dL
- Pregnancy
- Allergy or prior reaction to contrast material
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Utah Health Science Center
Salt Lake City, Utah, 84132
About this study
Official title: A Study of Electrocardiogram (ECG) Guidance for Placement of Peripherally Inserted Central Catheters (PICC)
This study is designed to obtain information for design purposes on use of an ECG guided monitoring system to aid in the correct placement of PICC lines.
There is no formal study hypothesis.
Read the detailed description
PICC line placement is a common procedure, made more difficult by the need to ensure that catheter tip placement is in an acceptable location, typically the superior vena cava (SVC), and ideally at the junction of the SVC and right atrium. Tip location is determined at present by chest X-ray, which is performed after the procedure. If the tip location is incorrect, additional procedures and/or X-rays are needed until proper placement is ensured.
Use of an electrode placed inside the catheter during insertion has been reported to provide identifiable changes in the p-wave sufficient to guide placement. This study is designed to collect ECG and catheter depth information during routine PICC placement procedures, and to correlate these ECG changes to tip location as determined by contrast enhanced fluoroscopy.
- Being tested
- ECG-guided PICC placement
- Keywords
- ECG PICC, Patients undergoing PICC placement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECG-guided PICC placementDevice
Patients undergoing PICC placement will have ECG data collected as a function of tip location.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Male or female inpatients, age ≥ 18 and ≤ 80 years, who are in normal sinus rhythm and do not have a pacemaker or other indwelling intracardiac device and require PICC insertion for their routine care will be studied. Intervention: ECG-guided Power PICC placement. Receives: Device: ECG-guided PICC placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distance of Maximum P-wave Amplitude in Relation to Superior Vena Cava (SVC)/Right Atrium(RA) Junction
In order to determine correlation of PICC tip location with the intracatheter ECG, the PICC was advanced at 1cm increments and the p-wave observed for amplitude changes.
Measured: during catheter insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2008 (estimated)
- Study startJun 2008
- Primary completionDec 2008
- Study completionMar 2009
Why it stopped: Enrollment rate was too slow.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary Focus: Adult Subjects Who Require PICC PlacementStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- C. R. Bard
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andrew D Michaels, MD, Principal investigator, University of Utah Health Science Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00742053
- Sponsor's protocol ID
- Bard 3001
- Status last verified
- Jul 2017
- First submitted
- 25 Aug 2008
- Last updated
- 10 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Smith B, Neuharth RM, Hendrix MA, McDonnall D, Michaels AD. Intravenous electrocardiographic guidance for placement of peripherally inserted central catheters. J Electrocardiol. 2010 May-Jun;43(3):274-8. doi: 10.1016/j.jelectrocard.2010.02.003. Epub 2010 Mar 6.
PubMed 20206940
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Electrocardiogram (ECG) Guidance for Placement of Peripherally Inserted Central Catheters (PICC)
- ClinicalTrials.gov ID
- NCT00742053
- Acronym / sponsor ID
- Bard 3001
- Keywords
- ECG PICC, Patients undergoing PICC placement
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrollment rate was too slow.
- Enrolment
- 7 participants (actual)
- Lead sponsor
- C. R. BardIndustry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 27 Aug 2008 (estimated)
- Results
- Posted 31 Aug 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to obtain information for design purposes on use of an ECG guided monitoring system to aid in the correct placement of PICC lines.
There is no formal study hypothesis.
Detailed description
PICC line placement is a common procedure, made more difficult by the need to ensure that catheter tip placement is in an acceptable location, typically the superior vena cava (SVC), and ideally at the junction of the SVC and right atrium. Tip location is determined at present by chest X-ray, which is performed after the procedure. If the tip location is incorrect, additional procedures and/or X-rays are needed until proper placement is ensured.
Use of an electrode placed inside the catheter during insertion has been reported to provide identifiable changes in the p-wave sufficient to guide placement. This study is designed to collect ECG and catheter depth information during routine PICC placement procedures, and to correlate these ECG changes to tip location as determined by contrast enhanced fluoroscopy.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: ECG-guided PICC placementMale or female inpatients, age ≥ 18 and ≤ 80 years, who are in normal sinus rhythm and do not have a pacemaker or other indwelling intracardiac device and require PICC insertion for their routine care will be studied. Intervention: ECG-guided Power PICC placement. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Require Power PICC placement as standard care
- Signed informed consent
Key exclusion criteria (6 listed)
- Has an intracardiac device
- Does not have normal sinus rhythm
- Has known abnormality of central venous system
- Plasma creatinine >=1.5 mg/dL
- Pregnancy
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 |
|---|---|---|
| ECG-guided PICC placementPatients undergoing PICC placement will have ECG data collected as a function of tip location. | Device | 1 |
Primary outcome
Distance of Maximum P-wave Amplitude in Relation to Superior Vena Cava (SVC)/Right Atrium(RA) Junction
Time frame: during catheter insertion
In order to determine correlation of PICC tip location with the intracatheter ECG, the PICC was advanced at 1cm increments and the p-wave observed for amplitude changes.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 20206940Smith B, Neuharth RM, Hendrix MA, McDonnall D, Michaels AD. Intravenous electrocardiographic guidance for placement of peripherally inserted central catheters. J Electrocardiol. 2010 May-Jun;43(3):274-8. doi: 10.1016/j.jelectrocard.2010.02.003. Epub 2010 Mar 6.
- Individual participant dataSharing planned: No
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.
Andrew D Michaels, MD principal investigator
University of Utah Health Science Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ECG-guided PICC placement in people with Primary Focus: Adult Subjects Who Require PICC Placement, run by C. R. Bard 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 2 inclusion and 6 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: stopped early, as of the sponsor's last update on 10 Aug 2017. 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?
Yes. Results are posted in the registry (first posted 31 Aug 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Distance of Maximum P-wave Amplitude in Relation to Superior Vena Cava (SVC)/Right Atrium(RA) Junction (time frame: during catheter insertion). 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 NCT00742053, 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 10 Aug 2017.