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Peripherally Inserted Central Catheter (PICC) is considered a central venous line placement (CVL) which mandates the confirmation of the tip's location. At present, most CVL's position are confirmed by radiographic method either by in-procedure fluoroscopy or post-insertion x-ray. For CVLs placed from upper body (from internal jugular vein, subclavian veins or upper arm veins), the intracavitary electrocardiogram (iECG) can also be used.
Intracavitary ECG are proven effective for tip confirmation and provide some benefits i.e. lower cost, decrease exposure to harmful radiation for care providers and also the patients, require less personals and equipments, provide real-time confirmation as comparable to fluoroscopy, etc. There are several devices and makes of iECG apparatus but B.Braun-Certodyn® remains the only available system in our institution. The limitation is the availability of the Certodyn devices on each locations where CVL will be placed i.e. operating theater, intensive care unit, bedside placement, radiology suite, etc. Since the connecting wire is only supplied in the certain CVL kits under B.Braun brand, this has rendered iECG for other types or makes of CVL or PICC line become even more difficult.
Self-invented connector wire for iECG (PS wire) has been made and used effectively in the past few years at Siriraj hospital. The patent registration is underway and the author seek to compare this PS wire against the commercial Certodyn system.
Objective
Materials, participants and study method
Equipments required:
1) Self-invented iECG wire (PS wire) 2) Commercial iECG system which consists of the Certodyn and the wire. 3) Standard ECG monitoring system which can display and printout the ECG tracing. 4) A digital ECG caliper which can measure P wave amplitude and noise segment in millimeter up to 2 decimal points. Study method
Data analysis
Demographic data, type of catheter, depth of catheter where giant P wave obtained and final position of catheter will be recorded.
Each study patient produce 3 ECG print outs which are -baseline surface lead II ECG
All 3 ECG print outs will be compared for quality and the length noisy ECG segment (determined as the ECG with interference artifact of baseline > 1 mm) will also be measured in mm.
6) All measurement will be analyzed statistically to determine the differences between the 2 systems.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PS wire | Experimental | self-invented iECG wire |
|
| Certodyn | Active Comparator | Commercially available iECG system - Certodyn |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PS wire | Device | The wiring connection used to convey ECG signal from inside the body |
|
| Measure | Description | Time Frame |
|---|---|---|
| Signal noise ratio | Measuring the segment of ECG noise (if exists) in millimeters compare to the total ECG segment. Compare this signal noise ratio between the baseline surface ECG, the self-invented wire derived iECG and the Certodyn derived iECG. | 10 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| The amplitude of giant P Wave | Measure the amplitude of each giant P wave obtained from ECG print out from iECG derived from both certodyn and self-invented iECG wire. | 5 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Prasert Sawasdiwipachai, MD | Contact | 66874147409 | prasert.saw@mahidol.ac.th | |
| Vithaya Chaithiraphan, MD | Contact | 6687414708 | vithayac@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Prasert Sawasdiwipachai, MD | Anesthesiology department Siriraj hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Siriraj hospital, Mahidol university | Recruiting | Bangkok Noi | Bangkok | 10700 | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 1. Oster, D.D. "Improving ECG trace quality." Biomedical Instrumentation & Technology, 2000; 34: 219-222. 2. Corsten SA, van Dijk B, Bakker NC, de Lange JJ, Scheffer GJ. Central venous catheter placement using the ECG-guided Cavafix-Certodyn SD catheter. J Clin Anesth. 1994; 6(6): 469-72. 3. Pittiruti M, La Greca A, Scoppettuolo G. The electrocardiographic method for positioning the tip of central venous catheters. J Vasc Access. 2011; 12(4): 280-91. 4. Pittiruti M, Bertollo D, Briglia E, Buononato M, Capozzoli G, De Simone L, La Greca A, Pelagatti C, Sette P. The intracavitory ECG method for positioning the tip of central venous catheters: results of an italian multicenter study. J Vasc Access. 2012; 13(3):357-65. 5. Wang G, Guo L, Jiang B, Huang M, Zhang J, Qin Y. Factors Influencing Intracavitory Electrocardiographic P-Wave Changes during Central Venous Catheter Placement. PLoS One. 201510(4):e0124846. 6. Yuan L, Li R, Meng A, Feng Y, Wu X, Yang Y, et al. Superior success rate of intracavitory electrocardiogram guidance for peripherally inserted central catheter placement in patients with cancer: A randomized open-label controlled multi center study. PLoO One. 2017; 12(3):e0171630. |
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Single center, prospective, cross over study
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unlabeled ECG print
| Department of Anesthesiology, Faculty of Medicine, Siriraj Hospital | Recruiting | Bangkok | 10700 | Thailand |
|