Self-invented Intracavitary ECG Wire VS the Commercial System - Certodyn®

NCT03697291 | Unknown

• 1 other identifier: Si 548/2018
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Central Line Complication

Keywords

Self invented iECG wire; PS wire; Certodyn; intracavitary ECG; PICC line; giant P wave

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• The amplitude of giant P Wave

  5 minutes

Study Arms (2)

PS wire

EXPERIMENTAL

self-invented iECG wire

Device: PS wire

Certodyn

ACTIVE COMPARATOR

Commercially available iECG system - Certodyn

Device: PS wire

Interventions

PS wire DEVICE

The wiring connection used to convey ECG signal from inside the body

Also known as: Self-invented iECG wire

Certodyn; PS wire

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient age 18 years and above.
• Requires PICC line insertion from upper torso.

You may not qualify if:

• Children younger than 18 years.
• Patient with atrial fibrillation or other rhythms not generated from intrinsic SA node i.e. pacer, atrial fibrillation, etc.
• Unstable hemodynamic.
• Patient with history arrhythmias.
• Patient with HR \> 120 bpm.
• Patients with hypercoagulable state.
• Allergy to heparin.
• Patients with known heparin induced thrombocytopenia.
• Patients with known Creutzfeldt-Jakob Disease.

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (2)

Siriraj hospital, Mahidol university

Bangkok Noi, Bangkok, 10700, Thailand

RECRUITING

Department of Anesthesiology, Faculty of Medicine, Siriraj Hospital

Bangkok, 10700, Thailand

RECRUITING

Related Publications (1)

• 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.

  BACKGROUND

Study Officials

• Prasert Sawasdiwipachai, MD

  Anesthesiology department Siriraj hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Prasert Sawasdiwipachai, MD

CONTACT

66874147409; prasert.saw@mahidol.ac.th

Vithaya Chaithiraphan, MD

CONTACT

6687414708; vithayac@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: unlabeled ECG print
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Single center, prospective, cross over study

Study Record Dates

• First Submitted: October 1, 2018
• First Posted: October 5, 2018
• Study Start: August 1, 2018
• Primary Completion: June 30, 2019
• Study Completion: October 31, 2019
• Last Updated: October 9, 2018

Record last verified: 2018-10

Locations

TH (2)