Insertion of PICC With Intracavitary ECG Navigation

Study Overview
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Brief Summary
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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
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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.

Official Title
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PICC Insertion With the Use of IC ECG Navigation to Confirm the PICC Tip Location Compare to Chest X-ray

Conditions
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Long-term Venous Access

Intervention / Treatment
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* Other: ECG verification
* Other: X-ray verification


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: The study subjects enrolled in the study will be assigned to one study group. No randomization is performed.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PICC catheter placement<br>Study subjects in whom placement of the PICC catheter is indicated | Other: ECG verification<br>* The correct positioning of the PICC catheter tip will be verified using ECG.<br>Other: X-ray verification<br>* The correct positioning of the PICC catheter tip will be verified using X-ray imaging.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time interval between ECG and X-ray | The time elapsed between performing the ECG examination and the X-ray examination will be measured in minutes. | 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success-rate of correct PICC tip location | 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. | 2 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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peripherally inserted central catheter, ECG navigation, chest x-ray, PICC tip navigation, catheter tip location, intracavitary ECG