Catheterization, Peripheral Clinical Trial
— IVEKGOfficial title:
May Intravascular Electrocardiography (IVECG) During Insertion of Peripheral Inserted Central-venous Catheters (PICC-line) Replace Chest X-ray?
NCT number | NCT03197246 |
Other study ID # | SPL4911 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 17, 2017 |
Est. completion date | August 22, 2018 |
Verified date | August 2018 |
Source | Norwegian University of Science and Technology |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 100 |
Est. completion date | August 22, 2018 |
Est. primary completion date | July 31, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - In need for PICC - >18 years old - Competent to give consent Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Norway | Innlandet Hospital Trust Lillehammer | Lillehammer | Oppland |
Lead Sponsor | Collaborator |
---|---|
Norwegian University of Science and Technology | Sykehuset Innlandet HF |
Norway,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 45 minutes |
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