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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date August 2018
Source Norwegian University of Science and Technology
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
IVECG
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-ray
Standard method; PICC confirmed by chest X-ray after the insertion (postoperatively)

Locations

Country Name City State
Norway Innlandet Hospital Trust Lillehammer Lillehammer Oppland

Sponsors (2)

Lead Sponsor Collaborator
Norwegian University of Science and Technology Sykehuset Innlandet HF

Country where clinical trial is conducted

Norway, 

Outcome

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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