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| Name | Class |
|---|---|
| Retia Medical | UNKNOWN |
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The overall goal of this collaborative study is to advance the novel "pulse contour analysis" to the point at which it can be incorporated into a real-time device. The specific objective is to establish an auto-calibration algorithm that conveniently yields cardiac output (CO) in units of liters-per-minute. To achieve this objective, the waveforms for analysis and reference pulmonary artery catheter CO measurements will be recorded from critically ill patients and then analyzed off-line at Retia Medical. Successful completion of this study may ultimately help lead to improved outcomes of critically ill patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Retia Non-Invasive Sensors | Other | Sensors will be placed on the patient and connected to an amplifier that produces a waveform for 8 hours post cardiac surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Retia Non-Invasive Sensors | Device | Three adhesive sensor patches (similar to ECG patches) will be placed on the chest and a sensor similar to a pulse oximeter will be placed on the toe. The sensors will be connected to an electrical amplifier that produces a waveform. |
| Measure | Description | Time Frame |
|---|---|---|
| Establishment of a Dataset to Create an Algorithm to Measure Cardiac Output | The primary outcome of this work is to establish a dataset that would enable the calculation of a predicted cardiac output using waveform analysis from multiple sensors. The primary outcome of this work is the number of subjects that successfully contributed data. | 8 hours post cardiac surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James M Blum, MD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Retia Non-Invasive Sensors | Sensors will be placed on the patient and connected to an amplifier that produces a waveform for 8 hours post cardiac surgery. Retia Non-Invasive Sensors: Three adhesive sensor patches (similar to ECG patches) will be placed on the chest and a sensor similar to a pulse oximeter will be placed on the toe. The sensors will be connected to an electrical amplifier that produces a waveform. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Retia Non-Invasive Sensors | Sensors will be placed on the patient and connected to an amplifier that produces a waveform for 8 hours post cardiac surgery. Retia Non-Invasive Sensors: Three adhesive sensor patches (similar to ECG patches) will be placed on the chest and a sensor similar to a pulse oximeter will be placed on the toe. The sensors will be connected to an electrical amplifier that produces a waveform. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Establishment of a Dataset to Create an Algorithm to Measure Cardiac Output | The primary outcome of this work is to establish a dataset that would enable the calculation of a predicted cardiac output using waveform analysis from multiple sensors. The primary outcome of this work is the number of subjects that successfully contributed data. | patients had undergone routine cardiac surgery. some patients did not have PA catheters placed and subsequently data was not obtained on cardiac output. | Posted | Count of Participants | Participants | 8 hours post cardiac surgery |
|
2 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Retia Non-Invasive Sensors | Sensors will be placed on the patient and connected to an amplifier that produces a waveform for 8 hours post cardiac surgery. Retia Non-Invasive Sensors: Three adhesive sensor patches (similar to ECG patches) will be placed on the chest and a sensor similar to a pulse oximeter will be placed on the toe. The sensors will be connected to an electrical amplifier that produces a waveform. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| James Blum | Emory University | 404-778-3482 | jmblum@emory.edu |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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| Participants |
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| Age, Continuous | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 0 |
| 77 |
| 0 |
| 77 |
The PI is not involved with the ultimate analysis of the data which is to be used for proprietary algorithm development. The PI was engaged with his opinion on algorithm development and review of waveform data.