Goal-directed CPR Using Cerebral Oximetry
Goal-Directed Cardiopulmonary Resuscitation in Cardiac Arrest Using a Novel Physiological Target
2 other identifiers
interventional
150
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2022
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 10, 2021
CompletedFirst Posted
Study publicly available on registry
June 14, 2021
CompletedStudy Start
First participant enrolled
February 11, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2025
CompletedMarch 27, 2025
March 1, 2025
3.5 years
June 10, 2021
March 24, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rate of Return of Spontaneous Circulation (ROSC)
Day 0
Secondary Outcomes (6)
Cerebral Performance Category (CPC) Score
Day 1-2
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
Release of interleukin (IL)-6
Day 0
- +1 more secondary outcomes
Study Arms (2)
Physiological Feedback CPR
EXPERIMENTALNon-Physiological (Audiovisual) Feedback CPR
ACTIVE COMPARATORInterventions
Non-physiologically guided CPR using AV feedback (integrated into defibrillators)
Physiological feedback CPR using an optimal regional O2 Saturation (rSO2), End-tidal CO2 (ETCO2) or combined (rSO2/ETCO2) target
Eligibility Criteria
You may qualify if:
- In-hospital cardiac arrest patient
- Age ≥18 years
- Age \<80 years
- CPR lasting ≥5 minutes
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
NYU Langone Health
New York, New York, 10016, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sam Parnia, MD, PhD
NYU Langone Health
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 10, 2021
First Posted
June 14, 2021
Study Start
February 11, 2022
Primary Completion
July 31, 2025
Study Completion
July 31, 2025
Last Updated
March 27, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
- Access Criteria
- 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.
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.