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

Catheterization, Peripheral Clinical Trial

— IVEKG  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03197246
• Other study ID #: SPL4911
• Status: Completed
• Phase: N/A
• Start date: July 17, 2017
• Est. completion date: August 22, 2018

Study information

• Verified date: August 2018
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 22, 2018
• Est. primary completion date: July 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Catheterization, Peripheral
• Electrocardiography

Intervention

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

Locations

Country	Name	City	State
Norway	Innlandet Hospital Trust Lillehammer	Lillehammer	Oppland

Sponsors (2)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	Sykehuset Innlandet HF

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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