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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03197246
Acronym
IVEKG
Enrollment
100
Registered
2017-06-23
Start date
2017-07-17
Completion date
2018-08-22
Last updated
2018-08-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Catheterization, Peripheral, Electrocardiography

Keywords

PICC line, ECG, chest x-ray, IVECG, ICECG

Brief 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.

Interventions

DEVICEIVECG

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.

DEVICEChest X-ray

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

Sponsors

Sykehuset Innlandet HF
CollaboratorOTHER
Norwegian University of Science and Technology
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)

Masking description

The radiologist is masked/blinded in this clinical trial.

Intervention model description

RCT, two groups

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
PICC-tip placement examined by chest X-ray45 minutesPlacement 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

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026