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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-17

Study Completion Date

2018-08-22

Brief Summary

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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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Detailed Description

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Conditions

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Catheterization, Peripheral Electrocardiography

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

RCT, two groups

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

The radiologist is masked/blinded in this clinical trial.

Study Groups

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IVECG and chest X-ray

The patients in this group will be examined with perioperative IVECG for PICC tip placement, as well as standard postoperative chest X-ray.

Group Type EXPERIMENTAL

IVECG

Intervention Type 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.

Chest X-ray

Intervention Type DEVICE

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

Standard

Standard method, PICC tip placement confirmed by postoperative chest X-ray .

Group Type ACTIVE_COMPARATOR

Chest X-ray

Intervention Type DEVICE

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

Interventions

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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.

Intervention Type DEVICE

Chest X-ray

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

Intervention Type DEVICE

Other Intervention Names

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intravascular electrocardiography

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No