NCT04924985CompletedNot Applicable
Goal-Directed Cardiopulmonary Resuscitation in Cardiac Arrest Using a Novel Physiological Target
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- NYU Langone Health
- Enrollment
- 106
- Locations
- 2
- Primary Endpoint
- Rate of Return of Spontaneous Circulation (ROSC)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Arms & Interventions
Non-Physiological (Audiovisual) Feedback CPR
Active Comparator
Intervention: Non-Physiological Feedback CPR (Other)
Physiological Feedback CPR
Experimental
Intervention: Physiological Feedback CPR (Other)
Outcomes
Primary Outcomes
Rate of Return of Spontaneous Circulation (ROSC)
Time Frame: Day 0
Secondary Outcomes
- Release of Lactate(Day 0)
- Release of interleukin (IL)-6(Day 0)
- Cerebral Performance Category (CPC) Score(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)
Investigators
Study Sites (2)
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