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

May Intravascular Electrocardiography (IVECG) During Insertion of Peripheral Inserted Central-venous Catheters (PICC-line) Replace 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.

Study Overview

• Status: Completed
• Conditions: Electrocardiography; Catheterization, Peripheral
• Intervention / Treatment: Device: IVECG; Device: Chest X-ray

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Oppland
    • Lillehammer, Oppland, Norway, 2611
      • Innlandet Hospital Trust Lillehammer

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: 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.; Other Names: intravascular electrocardiography; Device: Chest X-ray; Standard method; PICC confirmed by chest X-ray after the insertion (postoperatively)
Active Comparator: Standard; Standard method, PICC tip placement confirmed by postoperative chest X-ray .	Device: Chest X-ray; Standard method; PICC confirmed by chest X-ray after the insertion (postoperatively)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Norwegian University of Science and Technology
• Collaborators: Sykehuset Innlandet HF
• Investigators: Study Chair: Baard Olav Jensen, MD,PhD, Sykehuset Innlandet HF; Study Director: Jon Magnussen, prof, NTNU, MH, Masterutdanning

Study record dates

Study Major Dates

• Study Start (Actual): July 17, 2017
• Primary Completion (Actual): July 31, 2018
• Study Completion (Actual): August 22, 2018

Study Registration Dates

• First Submitted: June 15, 2017
• First Submitted That Met QC Criteria: June 22, 2017
• First Posted (Actual): June 23, 2017

Study Record Updates

• Last Update Posted (Actual): August 23, 2018
• Last Update Submitted That Met QC Criteria: August 22, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: chest x-ray; ECG; PICC line; IVECG; ICECG
• Other Study ID Numbers: SPL4911

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This is a small project that will not produce any large amount of data. Thus, sharing data for other projects than described to the ethical committee is not relevant. So this is not the plan at this moment.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No