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| Name | Class |
|---|---|
| General Electric | INDUSTRY |
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The purpose of the Oxy-CAHN study is to improve the monitoring capabilities of newborn infants recovering from congenital heart surgery. Currently, we utilize important but unsophisticated measures, such as vital signs and lactate measurements, to monitor these patients. Although they are useful in categorizing patients as well or unwell, these signs currently lack the power quantify a patient's risk for cardiac arrest. More to the point, they are mostly indirect measures of what we really are assessing, which is tissue oxygen delivery.
Our group has significant expertise with devices which quantify the amount of oxygen that a baby consumes every minute. Historically, these values are more commonly used in combination with other measures to assess nutritional and metabolism status. In critically ill patients, however, the volume of oxygen consumed by a patient may be limited by the amount of oxygen their circulation delivers. This may represent a critical relationship, which has been previously described, but not exploited for the purpose of identifying patients with critically low oxygen delivery.
The aims of this study are therefore (1) to demonstrate that oxygen consumption can be safely and precisely measured continuously in newborns undergoing one of two common congenital heart surgeries, (2) to determine whether postoperative circulatory failure is associated with a precedent change in oxygen consumption, and (3) to determine whether the addition of the oxygen-based measurements (including oxygen consumption and venous oxygen saturations) to standardly measured parameters will add power in predicting which patients will experience postoperative circulatory failure.
If successful, this study may improve our capacity to non-invasively and continuously monitor patients following the highest risk congenital heart surgeries, and in the future,to create an algorithm which quantifies a patients risk for having a cardiac arrest. This may permit providers to intervene on these patients earlier, improving the morbidity and mortality associated with congenital heart disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HLHS | Experimental | Patients undergoing palliative repair. |
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| TGA | Active Comparator | Surgical repair of TGA. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| General Electric Healthcare E-COVX Gas Monitoring Module for VO2 Measurments | Device | Breath to breath VO2 measurements |
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| Measure | Description | Time Frame |
|---|---|---|
| Oxygen Consumption | Oxygen consumption is the mass of oxygen gas consumed per minute, measured as the difference between oxygen mass inspired versus exhaled per minute. | While mechanically ventilated, up to 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Computed Cardiac Index | A calculated estimate of cardiac index/systemic blood flow based on the Fick principle. | While mechanically ventilated, up to 14 days |
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Inclusion Criteria:
Exclusion Criteria:
Weight < 2 kg
Disease specific A. HLHS patients: Infants whose surgical plan includes a neonatal biventricularrepair will be excluded.
B. d-TGA/IVS patients: Newborns with any additional cardiac defect other than an atrial septal defect will be excluded.
Patients on ECMO preoperatively
Clinically significant tracheo-esophageal fistula or known preoperative air leak
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| Name | Affiliation | Role |
|---|---|---|
| John Kheir, MD | Boston Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston Children's Hospital | Boston | Massachusetts | 02115 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27806964 | Result | Mills KI, Kaza AK, Walsh BK, Bond HC, Ford M, Wypij D, Thiagarajan RR, Almodovar MC, Quinonez LG, Baird CW, Emani SE, Pigula FA, DiNardo JA, Kheir JN. Phosphodiesterase Inhibitor-Based Vasodilation Improves Oxygen Delivery and Clinical Outcomes Following Stage 1 Palliation. J Am Heart Assoc. 2016 Nov 2;5(11):e003554. doi: 10.1161/JAHA.116.003554. |
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| ID | Title | Description |
|---|---|---|
| FG000 | HLHS | Patients undergoing palliative repair. General Electric Healthcare E-COVX Gas Monitoring Module for VO2 Measurments: Breath to breath VO2 measurements Edwards Continuous SVO2 Catheter and Monitoring System - 4.5 fr: Edwards continuous SVO2 measurement system |
| FG001 | TGA With/Without VSD |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 1, 2013 |
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| Edwards Continuous SVO2 Catheter and Monitoring System - 4.5 fr | Device | Edwards continuous SVO2 measurement system |
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Surgical repair of TGA. General Electric Healthcare E-COVX Gas Monitoring Module for VO2 Measurments: Breath to breath VO2 measurements Edwards Continuous SVO2 Catheter and Monitoring System - 4.5 fr: Edwards continuous SVO2 measurement system |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | HLHS | Patients undergoing palliative repair. General Electric Healthcare E-COVX Gas Monitoring Module for VO2 Measurments: Breath to breath VO2 measurements Edwards Continuous SVO2 Catheter and Monitoring System - 4.5 fr: Edwards continuous SVO2 measurement system |
| BG001 | TGA/IVS | Surgical repair of TGA. General Electric Healthcare E-COVX Gas Monitoring Module for VO2 Measurments: Breath to breath VO2 measurements Edwards Continuous SVO2 Catheter and Monitoring System - 4.5 fr: Edwards continuous SVO2 measurement system |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| |||||||||||||||
| Region of Enrollment | Region of surgery | Count of Participants | 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 | Oxygen Consumption | Oxygen consumption is the mass of oxygen gas consumed per minute, measured as the difference between oxygen mass inspired versus exhaled per minute. | Posted | Mean | Standard Deviation | mL oxygen/min/m^2 | While mechanically ventilated, up to 14 days |
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| Secondary | Computed Cardiac Index | A calculated estimate of cardiac index/systemic blood flow based on the Fick principle. | The average cardiac index was measured for each patient twice per day | Posted | Mean | Standard Deviation | L/min/m2 | While mechanically ventilated, up to 14 days |
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14 days
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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 | HLHS | Patients undergoing palliative repair. General Electric Healthcare E-COVX Gas Monitoring Module for VO2 Measurments: Breath to breath VO2 measurements Edwards Continuous SVO2 Catheter and Monitoring System - 4.5 fr: Edwards continuous SVO2 measurement system | 0 | 21 | 0 | 21 | 0 | 21 |
| EG001 | TGA/IVS | Surgical repair of TGA. General Electric Healthcare E-COVX Gas Monitoring Module for VO2 Measurments: Breath to breath VO2 measurements Edwards Continuous SVO2 Catheter and Monitoring System - 4.5 fr: Edwards continuous SVO2 measurement system | 0 | 6 | 0 | 6 | 0 | 6 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John Kheir | Boston Childrens Hospital | 6173556000 | john.kheir@childrens.harvard.edu |
| May 8, 2020 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D014188 | Transposition of Great Vessels |
| D018636 | Hypoplastic Left Heart Syndrome |
| D006331 | Heart Diseases |
| D006330 | Heart Defects, Congenital |
| ID | Term |
|---|---|
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| Between 18 and 65 years |
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| >=65 years |
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