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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01HL151732-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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The proposed study is a single-center, randomized controlled pilot trial of adults who suffer in-hospital cardiac arrests. Using cerebral oxygenation and end-tidal carbon dioxide physiological targets to predict survival and neurological outcome, the impact of physiological-feedback CPR will be assessed. 150 adult patients who have a cardiac arrest event at NYU Tisch Hospital will be randomized to one of two treatment groups: (1) Physiological-Feedback CPR or (2) Non-Physiological (Audiovisual) Feedback CPR.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Physiological Feedback CPR | Experimental |
| |
| Non-Physiological (Audiovisual) Feedback CPR | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-Physiological Feedback CPR | Other | Non-physiologically guided CPR using AV feedback (integrated into defibrillators) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Return of Spontaneous Circulation (ROSC) | Day 0 |
| Measure | Description | Time Frame |
|---|---|---|
| Cerebral Performance Category (CPC) Score | Total range of score is 1 (Good cerebral performance) to 5 (Brain death). The higher the score, the worse the clinical condition. | Day 1-2 |
| Cerebral Performance Category (CPC) Score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sam Parnia, MD, PhD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | New York | New York | 10016 | United States |
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
The investigator who proposed to use the data will have access to the data upon reasonable request. Requests should be directed to Sam.Parnia@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Mar 22, 2022 | Mar 24, 2025 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D007511 | Ischemia |
| D015427 | Reperfusion Injury |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Physiological Feedback CPR | Other | Physiological feedback CPR using an optimal regional O2 Saturation (rSO2), End-tidal CO2 (ETCO2) or combined (rSO2/ETCO2) target |
|
Total range of score is 1 (Good cerebral performance) to 5 (Brain death). The higher the score, the worse the clinical condition.
| Day 30 |
| Change in mean rSO2 during CPR as markers of the quality of resuscitation | Day 0 |
| Change in mean ETCO2 during CPR as markers of the quality of resuscitation | Day 0 |
| Release of interleukin (IL)-6 | Day 0 |
| Release of Lactate | Day 0 |
| D011183 | Postoperative Complications |