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

Not Applicable

Completed

• Conditions: Catheterization, Peripheral; Electrocardiography
• Interventions: Device: IVECG; Device: Chest X-ray

• Registration Number: NCT03197246
• Lead Sponsor: Norwegian University of Science and Technology

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-06-15
• Study First Submitted QC: 2017-06-22
• Study First Posted: 2017-06-23
• Study Start: 2017-07-17
• Primary Completion: 2018-07-31
• Status Verified: 2018-08
• Study Completion: 2018-08-22
• Last Update Submitted: 2018-08-22
• Last Update Posted: 2018-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IVECG and chest X-ray	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.
IVECG and chest X-ray	IVECG	The patients in this group will be examined with perioperative IVECG for PICC tip placement, as well as standard postoperative chest X-ray.
Standard	Chest X-ray	Standard method, PICC tip placement confirmed by postoperative chest X-ray .

Primary Outcome Measures

Name	Time	Method
PICC-tip placement examined by chest X-ray	45 minutes	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

Trial Locations

Locations (1)

Innlandet Hospital Trust Lillehammer; 🇳🇴 Lillehammer, Oppland, Norway