Vascular Positioning System G4 Algorithm ECG Data Collection for Model Training Study, A Single Center Prospective Clinical Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Peripheral ICC
- Sponsor
- Teleflex
- Enrollment
- 27
- Locations
- 1
- Primary Endpoint
- VPS G4 System Digital Data vs GE MAC 5500 Ecg Machine Data
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
The objective of this study is to collect intravascular and extravascular echocardiogram (ECG) data from subjects receiving peripherally inserted central catheters (PICC) while using the Vascular Positioning System G4 and a 12 lead ECG machine. The data obtained will be used to update the G4 algorithm.
Detailed Description
This study seeks to collect synchronized digital data collected from the G4 and ECG machines during the PICC insertion procedure. A copy of the data will be downloaded from the G4 and ECG machines and submitted to the sponsor. Both the G4 and the ECG machine used for data collection in this study are FDA cleared/approved. Study Design: This is a single center prospective clinical study. All enrolled subjects will receive a 12-lead ECG during PICC insertion and a chest x-ray post insertion. ECG lead will be documented via photographic imaging. Duration of Subject Study Participation: Each subject's participation will start at the time of signing the informed consent and terminate upon completion of the x-ray.
Investigators
Eligibility Criteria
Inclusion Criteria
- •21 years of age or older
- •Scheduled for PICC insertion using the VPS G4 system
- •Willing to allow thoracic photos to be obtained after ECG lead placement
Exclusion Criteria
- •˂ 21 years of age
- •Patient has a pacemaker
- •Patient condition precluding ECG use and lead placement
- •Patient condition precluding radiographic imaging
- •Unwilling to allow thoracic photos to be obtained after ECG lead placement
Outcomes
Primary Outcomes
VPS G4 System Digital Data vs GE MAC 5500 Ecg Machine Data
Time Frame: From time of consent through completion of chest x-ray
All subjects for this study had their ECG recorded by the VPS G4 and GE MAC 5500 simultaneously. VPS G4 digital captured data recorded at 11.667 MHz measuring ISPTA.3 (mW/cm2) vs Digitally captured data from the GE MAC 5500 ECG Machine at a sample resolution of 4.88 μV/LSB @ 250 sps, 1.22 μV/LSB @ 500 sps and a frequency response of -3 dB @ 0.01 to 150 Hz vs time (s).