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

NCT03197246 | Completed

• 1 other identifier: SPL4911
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Catheterization, Peripheral; Electrocardiography

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

IVECG and chest X-ray

EXPERIMENTAL

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

Device: IVECG; Device: Chest X-ray

Standard

ACTIVE COMPARATOR

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

Device: Chest X-ray

Interventions

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.

Also known as: intravascular electrocardiography

IVECG and chest X-ray

Chest X-ray DEVICE

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

IVECG and chest X-ray; Standard

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• In need for PICC
• \>18 years old
• Competent to give consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Norwegian University of Science and Technology: lead
• Sykehuset Innlandet HF: collaborator

Study Sites (1)

Innlandet Hospital Trust Lillehammer

Lillehammer, Oppland, 2611, Norway

Location

MeSH Terms

Interventions

Diagnostic Imaging

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Baard Olav Jensen, MD,PhD

  Sykehuset Innlandet HF

  STUDY CHAIR

• Jon Magnussen, prof

  NTNU, MH, Masterutdanning

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The radiologist is masked/blinded in this clinical trial.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: RCT, two groups

Study Record Dates

• First Submitted: June 15, 2017
• First Posted: June 23, 2017
• Study Start: July 17, 2017
• Primary Completion: July 31, 2018
• Study Completion: August 22, 2018
• Last Updated: August 23, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)