Peripheral ICC
Conditions
Keywords
VPS, VPS G4, Vascular Positioning System G4, PICC navigation and tip confirmation
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.
Interventions
OTHERDigital ECG Data Collection
synchronized digital data collected from the G4 and ECG machines during the PICC insertion procedure
Sponsors
Duke University
Teleflex
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
21 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Male * 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
* Female * ˂ 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| VPS G4 System Digital Data vs GE MAC 5500 Ecg Machine Data | 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). |
Countries
United States
Participant flow
Recruitment details
Willing adult patients scheduled to receive a PICC insertion using the G4 tip navigation system were screened and enrolled in the study.
Participants by arm
| Arm | Count |
|---|---|
| Adult Patients Scheduled to Receive a PICC Insertion Adult patients scheduled to receive a PICC insertion using the Vascular Positioning System G4 tip navigation system
Digital ECG Data Collection: synchronized digital data collected from the G4 and ECG machines during the PICC insertion procedure | 20 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | 7 patients were excluded due to the inability to complete a chest radiograph. | 7 |
Baseline characteristics
| Characteristic | Adult Patients Scheduled to Receive a PICC Insertion |
|---|---|
| Age, Customized Subject 22 years old or older scheduled to receive a PICC using the VPS G4 and completion of xray | 20 participants who completed chest xray |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 15 Participants |
| Region of Enrollment United States | 20 participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
VPS G4 System Digital Data vs GE MAC 5500 Ecg Machine Data
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).
Time frame: From time of consent through completion of chest x-ray
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adult Patients Scheduled to Receive a PICC Insertion | VPS G4 System Digital Data vs GE MAC 5500 Ecg Machine Data | 20 subjects who digital data was captured |