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| ID | Type | Description | Link |
|---|---|---|---|
| 2R44HL082022-02 | U.S. NIH Grant/Contract | View source |
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Site PI left position and lack of a suitable replacement PI.
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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Cardiac output, the amount of blood pumped by the heart in one minute, will be measured in pediatric patients undergoing surgery involving cardiopulmonary bypass (CPB). Cardiac output will be measured after cardiopulmonary bypass using a device that employs ultrasound dilution technology. At times, cardiac output will be measured during a procedure called modified ultrafiltration (MUF). The ultrasound dilution cardiac output measurements will be validated or compared with cardiac output measurements made using other FDA approved techniques and devices.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pediatric cardiac output (CO) after CPB | Cardiac output measurements made in pediatric patients after cardiopulmonary bypass. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HCE101 Cardiopulmonary Support Monitor | Device | Measurement of cardiac output using ultrasound dilution technology. The ultrasound dilution technology is in the HCE101 Cardiopulmonary Support Monitor. |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiac output after cardiopulmonary bypass | Cardiac output will be measured in pediatric patients after undergoing surgery involving cardiopulmonary bypass | Less than 10 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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Cardiac output measurements made in pediatric patients after cardiopulmonary bypass.
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| Name | Affiliation | Role |
|---|---|---|
| Nikolai Krivitski, PhD, DSc | Transonic Systems Inc. | Principal Investigator |
| Alistair Phillips, MD | Nationwide Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | United States |
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