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

Study Overview
=================
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.

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

Conditions
-----------------
Catheterization, Peripheral, Electrocardiography

Intervention / Treatment
-----------------
* Device: IVECG
* Device: Chest X-ray


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: RCT, two groups
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IVECG and chest X-ray<br>The patients in this group will be examined with perioperative IVECG for PICC tip placement, as well as standard postoperative chest X-ray. | Device: IVECG<br>* 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.<br>* Other names: intravascular electrocardiography;Device: Chest X-ray<br>* Standard method; PICC confirmed by chest X-ray after the insertion (postoperatively)<br>|
| Active Comparator: Standard<br>Standard method, PICC tip placement confirmed by postoperative chest X-ray . | Device: Chest X-ray<br>* Standard method; PICC confirmed by chest X-ray after the insertion (postoperatively)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PICC line, ECG, chest x-ray, IVECG, ICECG