ECG Versus Ultrasound-guided Positioning of the Peripherally Inserted Central Catheter (PICC) Tip

Study Overview
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Brief Summary
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In the prevention of thrombosis related to catheter placement it is important to have a right position of the catheter tip. Therefor we want to assess which technique is the most successful in the placing of a PICC.

Detailed Description
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This is a randomised prospective single blinded study. All adult patients with an indication for PICC placement can be included. Patients will be randomised into two groups, one with ECG-guided placement followed by ultrasound control and the other with only ultrasound guided placement. After placement, in both groups, control radiography of the chest will be done which will be interpreted by an independent radiologist. For the ECG-guided group the ultrasound control of the tip position will be done by an independent, blind operator, after placement. For the only ultrasound guided placement group, the ultrasound will be done by a second operator during placement.

Official Title
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ECG Versus Ultrasound-guided Positioning of the Peripherally Inserted Central Catheter (PICC) Tip

Conditions
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Cancer, Infection, Malnutrition

Intervention / Treatment
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* Device: ECG-guided insertion of PICC
* Device: ULTRASOUND-guided insertion of PICC


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All adults with indication for PICC Exclusion Criteria: Age <18y Pregnant women

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ECG-guided insertion of PICC<br>Placement of the PICC (Peripherally Inserted Central Catheter ) ECG-guided insertion. | Device: ECG-guided insertion of PICC<br>* Comparison of placement of a PICC (Peripherally Inserted Central Catheter) by ECG-guidance vs. ULTRASOUND-guidance<br>Device: ULTRASOUND-guided insertion of PICC<br>* Comparison of placement of a PICC (Peripherally Inserted Central Catheter) by ECG-guidance vs. ULTRASOUND-guidance<br>|
| Experimental: ULTRASOUND-guided insertion of PICC<br>Placement of the PICC (Peripherally Inserted Central Catheter ) ULTRASOUND-guided. | Device: ECG-guided insertion of PICC<br>* Comparison of placement of a PICC (Peripherally Inserted Central Catheter) by ECG-guidance vs. ULTRASOUND-guidance<br>Device: ULTRASOUND-guided insertion of PICC<br>* Comparison of placement of a PICC (Peripherally Inserted Central Catheter) by ECG-guidance vs. ULTRASOUND-guidance<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with correct placement in the superior caval vein during PICC insertion, after either ECG or ultrasound guided insertion | The aim of the study is a comparison between two techniques to control correct positioning of the PICC | Whitin 5 minutes after catheter-placement | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of PICC-placement by ECG-guidance versus ultrasound-guidance |  | within 5 minutes | 
| frequency of necessity of replacement after chest-x-ray control | PICC tip should be located in the superior caval vein, close to the entrance of the right atrium. Other locations lead to repositioning. | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ECG, Ultrasound, Peripherally Inserted Central Catheters, PICC