Central Venous AccessNCT04466332
Comparison of Two ECG Guided PICC Insertion Techniques
A study testing LifeCath-CT PICC easy™ (Vygon) and PowerPICC-SOLO® (C.R. Bard) in people with Central Venous Access and Long Term Antibiotics, run by University of Lausanne at 1 site in Switzerland.
Trial summary
The aim of our study is to compare two ECG techniques for guiding Peripherally Inserted Central Venous Cather (PICC) in terms of accuracy of the final position of the catheter tip. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Central Venous Access, Long Term Antibiotics, Chemotherapy
- What is being tested?
- LifeCath-CT PICC easy™ (Vygon) and PowerPICC-SOLO® (C.R. Bard)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Sep 2020to 20 Aug 2021
- 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
- Informed Consent as documented by signature (Appendix Informed Consent Form)
- Adult > 18 years
- Referred to the interventional radiology department for PICC insertion
Who cannot join
- Known or suspected non-compliance
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
- Previous enrolment into the current study
- Enrolment of the investigator, his/her family members, employees and other dependent persons
- Impairment of the heart rhythm changing the presentation of the P wave (atrial fibrillation, atrial flutter, severe tachycardia, pacemaker driven rhythm)
- Enrolled in conflicting research study
Show all 9Show fewer
- Weight> 150 kg, technical limit for the fluoroscopy table
- Impossibility of obtaining informed consent
- Refusal to be informed in the event of a chance discovery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Two ECG Guided PICC Insertion Techniques, a Randomized Controlled Trial
The aim of our study is to compare two ECG techniques for guiding Peripherally Inserted Central Venous Cather (PICC) in terms of accuracy of the final position of the catheter tip.
Read the detailed description
One technique uses ECG signal transmission with saline water and allows external catheter length adjustment while the other technique uses a guidewire for signal transmission thus requiring prior catheter length adjustment
- Being tested
- LifeCath-CT PICC easy™ (Vygon), PowerPICC-SOLO® (C.R. Bard)
- Keywords
- PICC, ECG guidance, Central Venous Catheter, Catheterization
- Medical subject headings
- Hyperphagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LifeCath-CT PICC easy™ (Vygon)Device
ECG electrodes are placed on patient's chest ensuring that there is a distinguishable P-wave.
Upper arm selection is based on vein diameter and dominance, ultrasound is used to identify a suitable vein.
The patient is prepared using a maximal sterile barrier approach. The catheter is inserted into one of the veins (75-90° arm abduction) using ultrasound and modified Seldinger technique.
The PICC is advanced into the central circulation and used as an intracavitary electrode (connection with Vygocard2™). Saline water instilled through the catheter ensures conductivity.
The ECG is then used until displayed intracavitary P-wave has a maximal height without negative deflexion. Catheter is left at this point (cavo atrial junction).
The PICC hub side is then trimmed and the catheter part connected. The PICC is caped with a neutral bidirectional valve.
The puncture site is dressed and catheter stabilized. Chest Xray is obtained immediately after insertion to assess the position.
PowerPICC-SOLO® (C.R. Bard)Device
ECG electrodes are placed on patients chest ensuring that there is a distinguishable P-wave.
Upper arm selection is based on vein diameter and dominance, ultrasound is used to identify suitable vein.
The patient is prepared using a maximal sterile barrier approach. The catheter is inserted into one of the veins (75-90° arm abduction) using ultrasound and modified Seldinger technique.
The catheter's free end is cut to the anticipated length using anthropometric measurements (insertion/axillary crease+axillary crease/sternal notch+13cm) and the preloaded magnetic-tipped stylet (serving as intracavitary electrode) is put inside.
The PICC is advanced into central veins until intravascular ECG displays a P-wave with maximal height without negative deflexion. Catheter is left at this point (cavo atrial junction).
The puncture site is dressed and catheter stabilized. Chest Xray is obtained immediately after insertion to assess position.
| Study group | Role | What they receive |
|---|---|---|
| Saline ECG with Pilot Tip Location System | Experimental | PICC insertion using electrocardiographic guidance Pilot Tip Location System (TLS), ECG signal transmission is with saline water Receives: Device: LifeCath-CT PICC easy™ (Vygon) |
| Guidewire ECG with Sherlock Tip Confirmation System | Experimental | PICC insertion using electrocardiographic guidance Sherlock 3CG Tip Confirmation System (TCS), ECG signal transmission is with guidewire Receives: Device: PowerPICC-SOLO® (C.R. Bard) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distance from catheter tip to cavo-atrial junction (CAJ)
At the end of intervention tip position is measured on chest fluoroscopic X-ray.
Absolute distance in centimeters from tip to CAJ is measured on the image
Measured: At the end of intervention
Secondary outcomes (2)
Length of the outgoing catheter
Length of the outgoing catheter at the entry point near the bend of the elbow in centimeters
Measured: At the end of intervention
Haemostasis time
Haemostasis time at the puncture site entry point (0, 1, 3, 5, >5 minutes)
Measured: At the end of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2020
- Study start1 Sep 2020
- Primary completion1 Sep 2020
- Study completion20 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Venous AccessStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lausanne
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier Universitaire Vaudois
- Responsible party
- Principal investigator, Salah D. Qanadli, MD, PhD, University of Lausanne
- Investigators
- Salah Dine Qanadli, Prof. MD PhD, Study director, UNIL-CHUV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04466332
- Sponsor's protocol ID
- 2020-00583
- Status last verified
- Sep 2022
- First submitted
- 7 Jul 2020
- Last updated
- 28 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two ECG Guided PICC Insertion Techniques, a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04466332
- Acronym / sponsor ID
- 2020-00583
- Keywords
- PICC, ECG guidance, Central Venous Catheter, Catheterization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- University of LausanneUniversity, hospital or other
- Collaborators
- Centre Hospitalier Universitaire Vaudois
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Sep 2020 (actual)
- Study completion
- 20 Aug 2021 (actual)
- First posted
- 10 Jul 2020 (actual)
- 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.
The aim of our study is to compare two ECG techniques for guiding Peripherally Inserted Central Venous Cather (PICC) in terms of accuracy of the final position of the catheter tip.
Detailed description
One technique uses ECG signal transmission with saline water and allows external catheter length adjustment while the other technique uses a guidewire for signal transmission thus requiring prior catheter length adjustment
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Saline ECG with Pilot Tip Location System | Experimental | Device: LifeCath-CT PICC easy™ (Vygon)PICC insertion using electrocardiographic guidance Pilot Tip Location System (TLS), ECG signal transmission is with saline water |
| Guidewire ECG with Sherlock Tip Confirmation System | Experimental | Device: PowerPICC-SOLO® (C.R. Bard)PICC insertion using electrocardiographic guidance Sherlock 3CG Tip Confirmation System (TCS), ECG signal transmission is with guidewire |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Informed Consent as documented by signature (Appendix Informed Consent Form)
- Adult > 18 years
- Referred to the interventional radiology department for PICC insertion
Key exclusion criteria (9 listed)
- Known or suspected non-compliance
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
- Previous enrolment into the current study
- Enrolment of the investigator, his/her family members, employees and other dependent persons
- Impairment of the heart rhythm changing the presentation of the P wave (atrial fibrillation, atrial flutter, severe tachycardia, pacemaker driven rhythm)
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 |
|---|---|---|
| LifeCath-CT PICC easy™ (Vygon)ECG electrodes are placed on patient's chest ensuring that there is a distinguishable P-wave. Upper arm selection is based on vein diameter and dominance, ultrasound is used to identify a suitable vein. The patient is prepared using a maximal sterile barrier approach. The catheter is inserted into one of the veins (75-90° arm abduction) using ultrasound and modified Seldinger technique. The PICC is advanced into the central circulation and used as an intracavitary electrode (connection with Vygocard2™). Saline water instilled through the catheter ensures conductivity. The ECG is then used until displayed intracavitary P-wave has a maximal height without negative deflexion. Catheter is left at this point (cavo atrial junction). The PICC hub side is then trimmed and the catheter part connected. The PICC is caped with a neutral bidirectional valve. The puncture site is dressed and catheter stabilized. Chest Xray is obtained immediately after insertion to assess the position. | Device | Saline ECG with Pilot Tip Location System |
| PowerPICC-SOLO® (C.R. Bard)ECG electrodes are placed on patients chest ensuring that there is a distinguishable P-wave. Upper arm selection is based on vein diameter and dominance, ultrasound is used to identify suitable vein. The patient is prepared using a maximal sterile barrier approach. The catheter is inserted into one of the veins (75-90° arm abduction) using ultrasound and modified Seldinger technique. The catheter's free end is cut to the anticipated length using anthropometric measurements (insertion/axillary crease+axillary crease/sternal notch+13cm) and the preloaded magnetic-tipped stylet (serving as intracavitary electrode) is put inside. The PICC is advanced into central veins until intravascular ECG displays a P-wave with maximal height without negative deflexion. Catheter is left at this point (cavo atrial junction). The puncture site is dressed and catheter stabilized. Chest Xray is obtained immediately after insertion to assess position. | Device | Guidewire ECG with Sherlock Tip Confirmation System |
Primary outcome
Distance from catheter tip to cavo-atrial junction (CAJ)
Time frame: At the end of intervention
At the end of intervention tip position is measured on chest fluoroscopic X-ray. Absolute distance in centimeters from tip to CAJ is measured on the image
2 secondary outcomes
Length of the outgoing catheter
Time frame: At the end of intervention
Haemostasis time
Time frame: At the end of intervention
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 28 Sep 2022.
- Individual participant dataSharing planned: No
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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.
Salah Dine Qanadli, Prof. MD PhD study director
UNIL-CHUV
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LifeCath-CT PICC easy™ (Vygon) and PowerPICC-SOLO® (C.R. Bard) in people with Central Venous Access and Long Term Antibiotics, run by University of Lausanne at 1 site in Switzerland.
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 9 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 28 Sep 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 Switzerland. 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?
Distance from catheter tip to cavo-atrial junction (CAJ) (time frame: At the end of intervention). 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 28 Sep 2022.