Indication for PICC PlacementNCT02498821
Time and Motion Related to PICC Insertion Process and Catheter Tip Confirmation
A study testing Chest X-ray, Sherlock 3CG® TCS and Peripherally Inserted Central Catheter (PICC) in people with Indication for PICC Placement, run by C. R. Bard at 4 sites in United States.
Trial summary
The purpose of the study is to evaluate differences in the time and costs between Sherlock 3CG® TCS and Chest X-ray to confirm the location of a Peripherally Inserted Central Catheter (PICC). Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Indication for PICC Placement
- What is being tested?
- Chest X-ray, Sherlock 3CG® TCS and Peripherally Inserted Central Catheter (PICC)
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 4 sitesUnited States
- Study dates
- May 2015to May 2016
- 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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Indicated for a PICC based on institutional practices.
- Able to read and comprehend English and has signed the Informed Consent Form to participate in the study.
- PICC line is placed while a study observer is available and on the study site at the time of the placement.
Who cannot join
- Infection, bacteremia, or septicemia is known or suspected.
- Body size is insufficient to accommodate the size of the implanted device.
- Known or is suspected to be allergic to materials contained in the device. Materials in the device include polyurethane, stainless steel, polyimide, silicone, polytetrafluorine (PTFE), and nickle titanium.
- Past irradiation of prospective insertion site.
- Previous episodes of venous thrombosis or vascular surgical procedures at the prospective placement site.
- Local tissue factors will prevent proper device stabilization and/or access.
Show all 15Show fewer
- Under the age of 22.
- Receiving the PICC as a replacement with an over-the-wire exchange.
- Pregnant or lactating.
- Anatomical irregularities (structural and vascular of the central venous system) which may compromise catheter insertion in both the primary arm and contralateral arm.
- Previously enrolled in this clinical study or is participating in another clinical study that is contraindicative to the treatment or outcomes of this investigation.
- Artificial heart or heart transplant.
- Anatomical abnormalities of the central venous system.
- Atrial fibrillation or other atrial arrhythmia's in which a P wave was not consistently present on ECG.
- Clinician is unable to obtain accurate external measurement due to anatomical abnormalities or personal/medical equipment.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of Maryland - Baltimore
Baltimore, Maryland, 21201
Florida Hospital
Maitland, Florida, 32751
Unity Hospital
Rochester, New York, 14626
Peninsula Regional Medical Center
Salisbury, Maryland, 21801
About this study
Official title: Time and Motion Related to PICC Insertion Process and Catheter Tip Confirmation: A Comparison Between Standard of Care (Chest X-ray) and Sherlock 3CG® TCS
The purpose of the study is to evaluate differences in the time and costs between Sherlock 3CG® TCS and Chest X-ray to confirm the location of a Peripherally Inserted Central Catheter (PICC).
Read the detailed description
The study is a cross-sectional, observational design, characterized as a time and motion study. The study will observe subjects and specific outcomes from the time a PICC insertion procedure begins until the subject is cleared for administration of their prescribed therapy. It will compare two approaches for PICC line placement and confirmation of PICC tip placement.
The two methods for placing and confirming PICC lines to be examined in this study are: 1) Standard of Care, defined as PICC line placement with Chest X-ray tip confirmation, and 2) Sherlock 3CG® TCS magnetic tracking PICC placement and ECG-based tip confirmation. These two approaches are currently in use, and are not investigational.
The study will evaluate the time elapsed from the beginning of PICC line placement procedure through the catheter tip confirmation (subject released for IV therapy). A researcher will observe from the time the catheter kit is opened until your catheter is cleared for administration of treatment. Limited subject follow-up includes review of subject medical records related to the PICC line placement. Subjects will be followed only up to the point at which the PICC line tip has been confirmed and the subject has been released to receive IV therapy. For most subjects, all study data will be collected on Day 1.
The study is expected to include 120 subjects, 60 subjects will have confirmed PICC line placement using Chest X-ray, and 60 will have confirmed PICC line placement using Sherlock 3CG® TCS. Each group of subjects will be from two clinical sites using either tip confirmation method, for a total of 4 study sites.
- Conditions
- Indication for PICC Placement
- Being tested
- Chest X-ray, Sherlock 3CG® TCS, Peripherally Inserted Central Catheter (PICC)
- Keywords
- PICC, central catheter, vascular access
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chest X-rayDevice
A Chest X-ray will be taken after healthcare providers have inserted the PICC to make sure it is in the correct location. The X-ray can tell your healthcare providers where the PICC is and whether is has been inserted correctly.
Sherlock 3CG® TCSDevice
The Sherlock 3CG® TCS is a device that is placed on the subject during the PICC insertion procedure, which helps your healthcare providers know where the PICC is as the healthcare providers are inserting it. It uses magnets and measures electrical activity of the heart to determine the location of the catheter in your body.
Peripherally Inserted Central Catheter (PICC)Procedure or surgery
A peripherally inserted central catheter (PICC) is a form of intravenous access that can be used for a prolonged period of time (e.g., for chemotherapy, antibiotics, total parenteral nutrition)
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care (Chest X-ray) | Other | Correct placement of the Peripherally Inserted Central Catheter (PICC) will be confirmed using standard of care (Chest X-ray). Receives: Device: Chest X-ray; Procedure: Peripherally Inserted Central Catheter (PICC) |
| Sherlock 3CG® TCS | Other | Correct placement of the Peripherally Inserted Central Catheter (PICC) will be confirmed using Sherlock 3CG® TCS magnetic tracking PICC placement and ECG-based tip confirmation. Receives: Device: Sherlock 3CG® TCS; Procedure: Peripherally Inserted Central Catheter (PICC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time From Initiation of Procedure (Opening of PICC Kit) to Catheter Tip Confirmation (Release for IV Therapy).
Measured: Usually ranges from 0 to 300 minutes from initiation of procedure
Secondary outcomes (8)
Total Number of Chest X-rays Performed Per Subject
Measured: Measured from initiation to completion of procedure (usually from 0 to 300 minutes)
Number of Participants With Malpositions
Measured: Measured from initiation to completion of procedure (usually from 0 to 300 minutes)
Number of Subsequent Malposition Attempts
This is the number of remaining malpositions following the first malposition adjustment attempt. All PICCs were inserted properly after the second malposition adjustment attempt.
Measured: Measured from initiation to completion of procedure (usually from 0 to 300 minutes)
Health Care Professional (HCP) Procedural Satisfaction (Overall)
HCPs were asked to rate satisfaction with the procedure (overall) on a scale from 0 to 10 with 0 meaning "not at all satisfied" and 10 meaning "extremely satisfied".
Measured: Measured immediately after the procedure completion (usually ranges from 0 to 300 minutes following procedure initiation).
Number of Additional Venous Access Devices (VADs) Required Due to PICC Not Being Ready for Use
Measured: Measured from initiation to completion of procedure (usually from 0 to 300 minutes)
Number of Medication Doses Missed Due to PICC Not Being Ready for Use
Measured: Measured from initiation to completion of procedure (usually from 0 to 300 minutes)
Number of Lab Draws Missed Due to PICC Not Being Ready for Use
Measured: Measured from initiation to completion of procedure (usually from 0 to 300 minutes)
Number of Overtime Hours Worked Per PICC Placement Procedure
Measured: Measured from initiation to completion of procedure (usually from 0 to 5 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2015 (estimated)
- Study startMay 2015
- Primary completionMay 2016
- Study completionMay 2016
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.
- Other trials for Indication for PICC PlacementStudies of the same condition, open and under way.
- More trials run by C. R. BardThe 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- C. R. Bard
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- KJT Group, Inc.
- Responsible party
- Sponsor
- Investigators
- Kenneth J Tomaszewski, PhD, Principal investigator, KJT Group, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02498821
- Sponsor's protocol ID
- BAS-14-004
- Status last verified
- Mar 2017
- First submitted
- 1 Jul 2015
- Last updated
- 31 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Time and Motion Related to PICC Insertion Process and Catheter Tip Confirmation: A Comparison Between Standard of Care (Chest X-ray) and Sherlock 3CG® TCS
- ClinicalTrials.gov ID
- NCT02498821
- Acronym / sponsor ID
- BAS-14-004
- Conditions
- Indication for PICC Placement
- Keywords
- PICC, central catheter, vascular access
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- C. R. BardIndustry (pharma, biotech, devices)
- Collaborators
- KJT Group, Inc.
- Study start
- May 2015
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 15 Jul 2015 (estimated)
- Results
- Posted 3 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to evaluate differences in the time and costs between Sherlock 3CG® TCS and Chest X-ray to confirm the location of a Peripherally Inserted Central Catheter (PICC).
Detailed description
The study is a cross-sectional, observational design, characterized as a time and motion study. The study will observe subjects and specific outcomes from the time a PICC insertion procedure begins until the subject is cleared for administration of their prescribed therapy. It will compare two approaches for PICC line placement and confirmation of PICC tip placement.
The two methods for placing and confirming PICC lines to be examined in this study are: 1) Standard of Care, defined as PICC line placement with Chest X-ray tip confirmation, and 2) Sherlock 3CG® TCS magnetic tracking PICC placement and ECG-based tip confirmation. These two approaches are currently in use, and are not investigational.
The study will evaluate the time elapsed from the beginning of PICC line placement procedure through the catheter tip confirmation (subject released for IV therapy). A researcher will observe from the time the catheter kit is opened until your catheter is cleared for administration of treatment. Limited subject follow-up includes review of subject medical records related to the PICC line placement. Subjects will be followed only up to the point at which the PICC line tip has been confirmed and the subject has been released to receive IV therapy. For most subjects, all study data will be collected on Day 1.
The study is expected to include 120 subjects, 60 subjects will have confirmed PICC line placement using Chest X-ray, and 60 will have confirmed PICC line placement using Sherlock 3CG® TCS. Each group of subjects will be from two clinical sites using either tip confirmation method, for a total of 4 study sites.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care (Chest X-ray) | Other | Device: Chest X-ray, Procedure: Peripherally Inserted Central Catheter (PICC)Correct placement of the Peripherally Inserted Central Catheter (PICC) will be confirmed using standard of care (Chest X-ray). |
| Sherlock 3CG® TCS | Other | Device: Sherlock 3CG® TCS, Procedure: Peripherally Inserted Central Catheter (PICC)Correct placement of the Peripherally Inserted Central Catheter (PICC) will be confirmed using Sherlock 3CG® TCS magnetic tracking PICC placement and ECG-based tip confirmation. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Indicated for a PICC based on institutional practices.
- Able to read and comprehend English and has signed the Informed Consent Form to participate in the study.
- PICC line is placed while a study observer is available and on the study site at the time of the placement.
Key exclusion criteria (15 listed)
- Infection, bacteremia, or septicemia is known or suspected.
- Body size is insufficient to accommodate the size of the implanted device.
- Known or is suspected to be allergic to materials contained in the device. Materials in the device include polyurethane, stainless steel, polyimide, silicone, polytetrafluorine (PTFE), and nickle titanium.
- Past irradiation of prospective insertion site.
- Previous episodes of venous thrombosis or vascular surgical procedures at the prospective placement site.
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 |
|---|---|---|
| Chest X-rayA Chest X-ray will be taken after healthcare providers have inserted the PICC to make sure it is in the correct location. The X-ray can tell your healthcare providers where the PICC is and whether is has been inserted correctly. | Device | Standard of Care (Chest X-ray) |
| Sherlock 3CG® TCSThe Sherlock 3CG® TCS is a device that is placed on the subject during the PICC insertion procedure, which helps your healthcare providers know where the PICC is as the healthcare providers are inserting it. It uses magnets and measures electrical activity of the heart to determine the location of the catheter in your body. | Device | Sherlock 3CG® TCS |
| Peripherally Inserted Central Catheter (PICC)A peripherally inserted central catheter (PICC) is a form of intravenous access that can be used for a prolonged period of time (e.g., for chemotherapy, antibiotics, total parenteral nutrition) | Procedure or surgery | Sherlock 3CG® TCS, Standard of Care (Chest X-ray) |
Primary outcome
Time From Initiation of Procedure (Opening of PICC Kit) to Catheter Tip Confirmation (Release for IV Therapy).
Time frame: Usually ranges from 0 to 300 minutes from initiation of procedure
8 secondary outcomes
Total Number of Chest X-rays Performed Per Subject
Time frame: Measured from initiation to completion of procedure (usually from 0 to 300 minutes)
Number of Participants With Malpositions
Time frame: Measured from initiation to completion of procedure (usually from 0 to 300 minutes)
Number of Subsequent Malposition Attempts
Time frame: Measured from initiation to completion of procedure (usually from 0 to 300 minutes)
Health Care Professional (HCP) Procedural Satisfaction (Overall)
Time frame: Measured immediately after the procedure completion (usually ranges from 0 to 300 minutes following procedure initiation).
Number of Additional Venous Access Devices (VADs) Required Due to PICC Not Being Ready for Use
Time frame: Measured from initiation to completion of procedure (usually from 0 to 300 minutes)
Number of Medication Doses Missed Due to PICC Not Being Ready for Use
Time frame: Measured from initiation to completion of procedure (usually from 0 to 300 minutes)
Number of Lab Draws Missed Due to PICC Not Being Ready for Use
Time frame: Measured from initiation to completion of procedure (usually from 0 to 300 minutes)
Number of Overtime Hours Worked Per PICC Placement Procedure
Time frame: Measured from initiation to completion of procedure (usually from 0 to 5 hours)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Kenneth J Tomaszewski, PhD principal investigator
KJT Group, Inc.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chest X-ray, Sherlock 3CG® TCS and Peripherally Inserted Central Catheter (PICC) in people with Indication for PICC Placement, run by C. R. Bard at 4 sites 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 3 inclusion and 15 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 31 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 3 Mar 2017). 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?
Time From Initiation of Procedure (Opening of PICC Kit) to Catheter Tip Confirmation (Release for IV Therapy). (time frame: Usually ranges from 0 to 300 minutes from initiation of procedure). 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 31 Mar 2017.