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Completed

NCT Number: NCT03197246

Intravascular ECG During Insertion of Peripheral Inserted Central-venous Catheters: Replacement for 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.

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Key information

Conditions

Catheterization, Peripheral Electrocardiography

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Innlandet Hospital Trust Lillehammer

Lillehammer, Oppland, 2611, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IVECG

Device

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.

Other names: intravascular electrocardiography

Chest X-ray

Device

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

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Collaborators

  • Sykehuset Innlandet HF

Registry information

Official study title

May Intravascular Electrocardiography (IVECG) During Insertion of Peripheral Inserted Central-venous Catheters (PICC-line) Replace Chest X-ray?

Acronym: IVEKG

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jun 23, 2017
Registry last updated
Aug 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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