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Intravascular ECG During Insertion of Peripheral Inserted Central-venous Catheters: Replacement for Chest X-ray? (IVEKG)

N

Norwegian University of Science and Technology

Status

Completed

Conditions

Catheterization, Peripheral
Electrocardiography

Treatments

Device: Chest X-ray
Device: IVECG

Study type

Interventional

Funder types

Other

Identifiers

NCT03197246
SPL4911

Details and patient eligibility

About

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.

Enrollment

100 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

100 participants in 2 patient groups

IVECG and chest X-ray
Experimental group
Description:
The patients in this group will be examined with perioperative IVECG for PICC tip placement, as well as standard postoperative chest X-ray.
Treatment:
Device: Chest X-ray
Device: IVECG
Standard
Active Comparator group
Description:
Standard method, PICC tip placement confirmed by postoperative chest X-ray .
Treatment:
Device: Chest X-ray

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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