Goal-directed CPR Using Cerebral Oximetry

Study Overview
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Brief Summary
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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.

Official Title
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Goal-Directed Cardiopulmonary Resuscitation in Cardiac Arrest Using a Novel Physiological Target

Conditions
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Ischemia, Reperfusion Injury

Intervention / Treatment
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* Other: Non-Physiological Feedback CPR
* Other: Physiological Feedback CPR


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: In-hospital cardiac arrest patient Age ≥18 years Age <80 years CPR lasting ≥5 minutes Exclusion Criteria: Patients < 18 years of age or > 80 years of age Out of hospital cardiac arrest patients ≥3 acute organ failures (defined as acute renal failure requiring dialysis, fulminant liver failure i.e. liver failure with INR≥1.5, respiratory failure requiring mechanical ventilation) Repeat in-hospital cardiac arrest event within 14 days of a prior cardiac arrest Presence of known raised intracranial pressure Presence of known traumatic brain injury or subarachnoid hemorrhage <14 days old, frontal lobe brain tumors or subdural hemorrhage Hyperbilirubinemia >1.0 mg/dl (based on the absorption of near-infrared light by bilirubin) Resuscitation using extra-corporeal membrane oxygenation (ECMO)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Physiological Feedback CPR<br> | Other: Physiological Feedback CPR<br>* Physiological feedback CPR using an optimal regional O2 Saturation (rSO2), End-tidal CO2 (ETCO2) or combined (rSO2/ETCO2) target<br>|
| Active Comparator: Non-Physiological (Audiovisual) Feedback CPR<br> | Other: Non-Physiological Feedback CPR<br>* Non-physiologically guided CPR using AV feedback (integrated into defibrillators)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Return of Spontaneous Circulation (ROSC) |  | Day 0 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CPR