Ischemia, Reperfusion Injury
Conditions
Keywords
CPR
Brief summary
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.
Interventions
OTHERNon-Physiological Feedback CPR
Non-physiologically guided CPR using AV feedback (integrated into defibrillators)
OTHERPhysiological Feedback CPR
Physiological feedback CPR using an optimal regional O2 Saturation (rSO2), End-tidal CO2 (ETCO2) or combined (rSO2/ETCO2) target
Sponsors
NYU Langone Health
National Heart, Lung, and Blood Institute (NHLBI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. In-hospital cardiac arrest patient 2. Age ≥18 years 3. Age \<80 years 4. CPR lasting ≥5 minutes
Exclusion criteria
1. Patients \< 18 years of age or \> 80 years of age 2. Out of hospital cardiac arrest patients 3. ≥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) 4. Repeat in-hospital cardiac arrest event within 14 days of a prior cardiac arrest 5. Presence of known raised intracranial pressure 6. Presence of known traumatic brain injury or subarachnoid hemorrhage \<14 days old, frontal lobe brain tumors or subdural hemorrhage 7. Hyperbilirubinemia \>1.0 mg/dl (based on the absorption of near-infrared light by bilirubin) 8. Resuscitation using extra-corporeal membrane oxygenation (ECMO)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of Return of Spontaneous Circulation (ROSC) | Day 0 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cerebral Performance Category (CPC) Score | Day 1-2 | Total range of score is 1 (Good cerebral performance) to 5 (Brain death). The higher the score, the worse the clinical condition. |
| 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 | — |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORSam Parnia, MD, PhD
NYU Langone Health
Outcome results
None listed