Venous InsufficiencyECG-PICCNCT02324504
Evaluation of Electrocardiographic Guidance in Accurate Peripherally Inserted Central Catheter Placement in Children.
A study testing C3 Wave ECG-based PICC Tip Confirmation System in people with Venous Insufficiency, run by Boston Children's Hospital at 1 site in United States.
Trial summary
This study will enroll up to 192 children less than 18 years of age, who will receive electrocardiographic guidance for placement of a PICC in addition to radiography done as standard care. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Venous Insufficiency
- What is being tested?
- C3 Wave ECG-based PICC Tip Confirmation System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to Dec 2017
- 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 Up to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age from birth to 17 years in need of a PICC as part of the medical treatment plan
- Suitable for an upper extremity PICC placement
- Hemodynamically stable, including patients stable on vasopressors
Who cannot join
- Hemodynamic instability
- Cardiac abnormality which leads to abnormal p-wave on ECG
- Arrhythmia at baseline, documented duirng the current hospital admission
- Presence of pacemaker or pacing wires which are currently actively pacing
- Patients who have undergone reconstructive cardiac surgery and/or have anatomic variance that would affect the location of the sinoatrial node in relation to the superior vena cava
- Premature neonate (<37 weeks estimated gestational age)
- Placement of PICC in lower extremity
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston Children's Hospital
Boston, Massachusetts, 02115
About this study
This study will enroll up to 192 children less than 18 years of age, who will receive electrocardiographic guidance for placement of a PICC in addition to radiography done as standard care. The investigators will determine the location of the PICC tip from both ECG and radiograph, and then measure the degree of correlation between the two methods.
Read the detailed description
The placement of peripherally inserted central catheters (PICCs) is an important component of medical care for a variety of patients. Current practice requires radiographic confirmation of catheter tip placement prior to use of the line for administration of medications. Often the final catheter tip position may be uncertain based on radiographic imaging. Other times, the catheter is malpositioned and requires adjustment and repeat radiographic imaging. In adult patients, a system of confirmation that is based on electrocardiographic activity has been implemented and is FDA approved. This study will enroll up to 192 children less than 18 years of age who will receive electrocardiographic guidance for placement of a PICC, in addition to radiography done as standard care. The investigators will determine the location of the PICC tip from both ECG and radiograph, and then measure the degree of correlation between the two methods.
- Conditions
- Venous Insufficiency
- Being tested
- C3 Wave ECG-based PICC Tip Confirmation System
- Keywords
- Peripherally Inserted Central Catheter (PICC), Electrocardiographic guidance, Reposition
- Medical subject headings
- Venous Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C3 Wave ECG-based PICC Tip Confirmation SystemDevice
The C3 Wave PICC tip detection system will be used to identify catheter tip location during the procedural placement of the catheter. This system includes an ECG monitor that will be connected to the guidewire used for catheter placement. The changes in the ECG tracing will guide correct catheter placement.
| Study group | Role | What they receive |
|---|---|---|
| Placement with C3 Wave Tip System | Experimental | Subjects will have their central catheters placed with the addition of the FDA approved C3 Wave ECG-Based PICC Tip Confirmation System to the standard institution protocol. The system will assist with location of the catheter tip in real-time, during the procedure. Receives: Device: C3 Wave ECG-based PICC Tip Confirmation System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Successful Placement of Peripherally Inserted Central Catheter (PICC)
Successful placement (based upon review of chest radiograph) of the PICC as determined by the tip location of:
- RA SVC junction (right atrium/superior vena cava) or
- Distal or lower SVC
Measured: Less than 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2014 (estimated)
- Study startJan 2016
- Primary completionDec 2016
- Study completionDec 2017
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 Venous InsufficiencyStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Agus, Boston Children's Hospital
- Investigators
- Michael SD Agus, MD, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02324504
- Sponsor's protocol ID
- IRB-P00015242
- Acronym
- ECG-PICC
- Status last verified
- Jul 2022
- First submitted
- 20 Nov 2014
- Last updated
- 25 Jul 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: Will share with investigators based upon specific requests.
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Electrocardiographic Guidance in Accurate Peripherally Inserted Central Catheter Placement in Children.
- ClinicalTrials.gov ID
- NCT02324504
- Acronym / sponsor ID
- ECG-PICC / IRB-P00015242
- Conditions
- Venous Insufficiency
- Keywords
- Peripherally Inserted Central Catheter (PICC), Electrocardiographic guidance, Reposition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 24 Dec 2014 (estimated)
- Results
- Posted 23 Feb 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will enroll up to 192 children less than 18 years of age, who will receive electrocardiographic guidance for placement of a PICC in addition to radiography done as standard care. The investigators will determine the location of the PICC tip from both ECG and radiograph, and then measure the degree of correlation between the two methods.
Detailed description
The placement of peripherally inserted central catheters (PICCs) is an important component of medical care for a variety of patients. Current practice requires radiographic confirmation of catheter tip placement prior to use of the line for administration of medications. Often the final catheter tip position may be uncertain based on radiographic imaging. Other times, the catheter is malpositioned and requires adjustment and repeat radiographic imaging. In adult patients, a system of confirmation that is based on electrocardiographic activity has been implemented and is FDA approved. This study will enroll up to 192 children less than 18 years of age who will receive electrocardiographic guidance for placement of a PICC, in addition to radiography done as standard care. The investigators will determine the location of the PICC tip from both ECG and radiograph, and then measure the degree of correlation between the two methods.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Placement with C3 Wave Tip System | Experimental | Device: C3 Wave ECG-based PICC Tip Confirmation SystemSubjects will have their central catheters placed with the addition of the FDA approved C3 Wave ECG-Based PICC Tip Confirmation System to the standard institution protocol. The system will assist with location of the catheter tip in real-time, during the procedure. |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age from birth to 17 years in need of a PICC as part of the medical treatment plan
- Suitable for an upper extremity PICC placement
- Hemodynamically stable, including patients stable on vasopressors
Key exclusion criteria (7 listed)
- Hemodynamic instability
- Cardiac abnormality which leads to abnormal p-wave on ECG
- Arrhythmia at baseline, documented duirng the current hospital admission
- Presence of pacemaker or pacing wires which are currently actively pacing
- Patients who have undergone reconstructive cardiac surgery and/or have anatomic variance that would affect the location of the sinoatrial node in relation to the superior vena cava
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 |
|---|---|---|
| C3 Wave ECG-based PICC Tip Confirmation SystemThe C3 Wave PICC tip detection system will be used to identify catheter tip location during the procedural placement of the catheter. This system includes an ECG monitor that will be connected to the guidewire used for catheter placement. The changes in the ECG tracing will guide correct catheter placement. | Device | Placement with C3 Wave Tip System |
Primary outcome
Number of Participants With Successful Placement of Peripherally Inserted Central Catheter (PICC)
Time frame: Less than 24 hours
Successful placement (based upon review of chest radiograph) of the PICC as determined by the tip location of: * RA SVC junction (right atrium/superior vena cava) or * Distal or lower SVC
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Will share with investigators based upon specific requests.
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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.
Michael SD Agus, MD principal investigator
Boston Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing C3 Wave ECG-based PICC Tip Confirmation System in people with Venous Insufficiency, run by Boston Children's Hospital 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 3 inclusion and 7 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 25 Jul 2022. 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 23 Feb 2018). 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?
Number of Participants With Successful Placement of Peripherally Inserted Central Catheter (PICC) (time frame: Less than 24 hours). 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 25 Jul 2022.