Insertion of PICC With Intracavitary ECG Navigation

Not Applicable

Completed

• Conditions: Long-term Venous Access
• Interventions: Other: ECG verification; Other: X-ray verification

• Registration Number: NCT04444479
• Lead Sponsor: University Hospital Ostrava

Brief Summary

The study subjects who are indicated for peripherally inserted central (PICC) catheter placement will undergo this procedure under the control of ECG, the correct position of the PICC catheter tip will be subsequently verified X-ray imaging.

Detailed Description

The study subjects who are indicated for PICC catheter placement will undergo this procedure under the control of electrocardiography (ECG), the correct position of the PICC catheter tip will be subsequently verified X-ray imaging.

Conducting this study should allow us to see the feasibility of using real-time ECG navigation, its accuracy comparing to the chest X-ray method. ´ The second goal is to eliminate chest X-ray as an obsolete method, Also the advantages and disadvantages of both methods will be assessed.

Study Timeline

• Study Start: 2020-06-10
• Study First Submitted: 2020-06-19
• Study First Submitted QC: 2020-06-19
• Study First Posted: 2020-06-23
• Primary Completion: 2023-01-31
• Study Completion: 2023-04-30
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-08
• Last Update Posted: 2023-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 450

Inclusion Criteria

• indication for establishing long-term venous access
• 18 years of age and over

Exclusion Criteria

• oncological patients
• non-signing the informed consent form

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PICC catheter placement	X-ray verification	Study subjects in whom placement of the PICC catheter is indicated
PICC catheter placement	ECG verification	Study subjects in whom placement of the PICC catheter is indicated

Primary Outcome Measures

Name	Time	Method
Time interval between ECG and X-ray	2 hours	The time elapsed between performing the ECG examination and the X-ray examination will be measured in minutes.

Secondary Outcome Measures

Name	Time	Method
Success-rate of correct PICC tip location	2 hours	The success-rate of correct PICC tip location will be determined using ECG navigation against the use of chest X-ray, and expressed as distance in centimetres from the target point.

Trial Locations

Locations (1)

University Hospital Ostrava; 🇨🇿 Ostrava, Moravian-Silesian Region, Czechia