Catheterization, PeripheralIVEKGNCT03197246
Intravascular ECG During Insertion of Peripheral Inserted Central-venous Catheters: Replacement for Chest X-ray?
A study testing IVECG and Chest X-ray in people with Catheterization, Peripheral and Electrocardiography, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
This study will provide further knowledge concerning the use of electrocardiography (ECG) signals for verification of peripherally inserted central catheter (PICC) tip placement. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Catheterization, Peripheral, Electrocardiography
- What is being tested?
- IVECG and Chest X-ray
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteNorway
- Study dates
- 17 Jul 2017to 22 Aug 2018
- 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
- In need for PICC
- >18 years old
- Competent to give consent
Who cannot join
- Not visible p-wave on surface ECG (electrocardiograph)
- Patients with known Atrial fibrillation or atrial flutter
- Implanted pacemaker (PM) and/or implanted Implantable Cardioverter Defibrillator (ICD)
- Not signed written informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: May Intravascular Electrocardiography (IVECG) During Insertion of Peripheral Inserted Central-venous Catheters (PICC-line) Replace Chest X-ray?
This study will provide further knowledge concerning the use of electrocardiography (ECG) signals for verification of peripherally inserted central catheter (PICC) tip placement. Furthermore, it will be investigating whether use of Intravascular ECG (IVECG) for this verification is just as good as or even better than the current standard method with chest X-ray. This can help promote a method that involves less radiation and increased safety for patients, while at the same time saving resources. If use of ECG signals from the PICC tip is an equally exact method for verification of correct PICC tip placement as chest X-ray verification, the IVECG could replace chest X-ray control.
- Conditions
- Catheterization, Peripheral, Electrocardiography
- Being tested
- IVECG, Chest X-ray
- Keywords
- PICC line, ECG, chest x-ray, IVECG, ICECG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IVECGDevice
Also called intravascular electrocardiography
Monitoring IVECG signals for verification for exact tip placement during the actual insertion of the PICC. When the p-wave amplitude increases the PICC-tip is in the superior vena cava. When max positive amplitude, the PICC-tip is by definition at the cavo atriale junction, and thereby in correct position.
Chest X-rayDevice
Standard method; PICC confirmed by chest X-ray after the insertion (postoperatively)
| Study group | Role | What they receive |
|---|---|---|
| IVECG and chest X-ray | Experimental | The patients in this group will be examined with perioperative IVECG for PICC tip placement, as well as standard postoperative chest X-ray. Receives: Device: IVECG; Device: Chest X-ray |
| Standard | Active comparator | Standard method, PICC tip placement confirmed by postoperative chest X-ray . Receives: Device: Chest X-ray |
What is being measured
The primary outcome is the main question the study is designed to answer.
PICC-tip placement examined by chest X-ray
Placement of PICC-tip examined by chest X-ray both in observation group and in control group. A radiologist will examine the distance from the tracheal carina to the PICC-tip, and this measure will be registered in mm in both groups. Further the radiologist will be answering a questionnaire regarding "correct placement of PICC-tip", YES or NO, which is defined as in the lower 1/3 of the superior vena cava or at the cavo atrial junction. Last also the anesthesiologist will be answering following question: Is the PICC-tip placement acceptable? YES or NO
Measured: 45 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2017
- Study start17 Jul 2017
- Primary completion31 Jul 2018
- Study completion22 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Catheterization, PeripheralStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- RCT, two groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Sykehuset Innlandet HF
- Responsible party
- Sponsor
- Investigators
- Baard Olav Jensen, MD,PhD, Study chair, Sykehuset Innlandet HFJon Magnussen, prof, Study director, NTNU, MH, Masterutdanning
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03197246
- Sponsor's protocol ID
- SPL4911
- Acronym
- IVEKG
- Status last verified
- Aug 2018
- First submitted
- 15 Jun 2017
- Last updated
- 23 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is a small project that will not produce any large amount of data. Thus, sharing data for other projects than described to the ethical committee is not relevant. So this is not the plan at this moment.
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- May Intravascular Electrocardiography (IVECG) During Insertion of Peripheral Inserted Central-venous Catheters (PICC-line) Replace Chest X-ray?
- ClinicalTrials.gov ID
- NCT03197246
- Acronym / sponsor ID
- IVEKG / SPL4911
- Conditions
- Catheterization, Peripheral, Electrocardiography
- Keywords
- PICC line, ECG, chest x-ray, IVECG, ICECG
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- Sykehuset Innlandet HF
- Study start
- 17 Jul 2017 (actual)
- Primary completion
- 31 Jul 2018 (actual)
- Study completion
- 22 Aug 2018 (actual)
- First posted
- 23 Jun 2017 (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.
This study will provide further knowledge concerning the use of electrocardiography (ECG) signals for verification of peripherally inserted central catheter (PICC) tip placement. Furthermore, it will be investigating whether use of Intravascular ECG (IVECG) for this verification is just as good as or even better than the current standard method with chest X-ray. This can help promote a method that involves less radiation and increased safety for patients, while at the same time saving resources. If use of ECG signals from the PICC tip is an equally exact method for verification of correct PICC tip placement as chest X-ray verification, the IVECG could replace chest X-ray control.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- RCT, two groups
| Arm | Type | Receives |
|---|---|---|
| IVECG and chest X-ray | Experimental | Device: IVECG, Device: Chest X-rayThe patients in this group will be examined with perioperative IVECG for PICC tip placement, as well as standard postoperative chest X-ray. |
| Standard | Active comparator | Device: Chest X-rayStandard method, PICC tip placement confirmed by postoperative chest X-ray . |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- In need for PICC
- >18 years old
- Competent to give consent
Key exclusion criteria (4 listed)
- Not visible p-wave on surface ECG (electrocardiograph)
- Patients with known Atrial fibrillation or atrial flutter
- Implanted pacemaker (PM) and/or implanted Implantable Cardioverter Defibrillator (ICD)
- Not signed written informed consent
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 |
|---|---|---|
| IVECGAlso: intravascular electrocardiographyMonitoring IVECG signals for verification for exact tip placement during the actual insertion of the PICC. When the p-wave amplitude increases the PICC-tip is in the superior vena cava. When max positive amplitude, the PICC-tip is by definition at the cavo atriale junction, and thereby in correct position. | Device | IVECG and chest X-ray |
| Chest X-rayStandard method; PICC confirmed by chest X-ray after the insertion (postoperatively) | Device | IVECG and chest X-ray, Standard |
Primary outcome
PICC-tip placement examined by chest X-ray
Time frame: 45 minutes
Placement of PICC-tip examined by chest X-ray both in observation group and in control group. A radiologist will examine the distance from the tracheal carina to the PICC-tip, and this measure will be registered in mm in both groups. Further the radiologist will be answering a questionnaire regarding "correct placement of PICC-tip", YES or NO, which is defined as in the lower 1/3 of the superior vena cava or at the cavo atrial junction. Last also the anesthesiologist will be answering following question: Is the PICC-tip placement acceptable? YES or NO
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 23 Aug 2018.
- Individual participant dataSharing planned: No. This is a small project that will not produce any large amount of data. Thus, sharing data for other projects than described to the ethical committee is not relevant. So this is not the plan at this moment.
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Near-Infrared Light for Peripheral Venous Catheterization in Adults With Difficult Venous Access
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Comparison of the Effectiveness of Ultrasound-guided Techniques and Infrared Illumination, Compared With the Standard Approach to Peripheral Venous Line Placement in People With Difficult Venous Access
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Single Lumen Midline Catheter vs Ultrasound Guided Peripheral IV as Performed by Bedside Emergency Department Registered Nurses
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Enrolling by invitation
Use of Hand Extension Rubber During Intravenous Catheter Placement
Pain, Anxiety
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.
Baard Olav Jensen, MD,PhD study chair
Sykehuset Innlandet HF
Jon Magnussen, prof study director
NTNU, MH, Masterutdanning
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IVECG and Chest X-ray in people with Catheterization, Peripheral and Electrocardiography, run by Norwegian University of Science and Technology at 1 site in Norway.
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 4 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 23 Aug 2018. 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 Norway. 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?
PICC-tip placement examined by chest X-ray (time frame: 45 minutes). 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 23 Aug 2018.