IschemiaNCT04924985
Goal-directed CPR Using Cerebral Oximetry
A study testing Non-Physiological Feedback CPR and Physiological Feedback CPR in people with Ischemia and Reperfusion Injury, run by NYU Langone Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ischemia, Reperfusion Injury
- What is being tested?
- Non-Physiological Feedback CPR and Physiological Feedback CPR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Feb 2022to 14 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- In-hospital cardiac arrest patient
- Age ≥18 years
- Age <80 years
- CPR lasting ≥5 minutes
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Goal-Directed Cardiopulmonary Resuscitation in Cardiac Arrest Using a Novel Physiological Target
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.
- Conditions
- Ischemia, Reperfusion Injury
- Being tested
- Non-Physiological Feedback CPR, Physiological Feedback CPR
- Keywords
- CPR
- Medical subject headings
- Ischemia, Reperfusion Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Physiological Feedback CPROther
Non-physiologically guided CPR using AV feedback (integrated into defibrillators)
Physiological Feedback CPROther
Physiological feedback CPR using an optimal regional O2 Saturation (rSO2), End-tidal CO2 (ETCO2) or combined (rSO2/ETCO2) target
| Study group | Role | What they receive |
|---|---|---|
| Physiological Feedback CPR | Experimental | Not described Receives: Other: Physiological Feedback CPR |
| Non-Physiological (Audiovisual) Feedback CPR | Active comparator | Not described Receives: Other: Non-Physiological Feedback CPR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Return of Spontaneous Circulation (ROSC)
Measured: Day 0
Secondary outcomes (6)
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.
Measured: 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.
Measured: Day 30
Change in mean rSO2 during CPR as markers of the quality of resuscitation
Measured: Day 0
Change in mean ETCO2 during CPR as markers of the quality of resuscitation
Measured: Day 0
Release of interleukin (IL)-6
Measured: Day 0
Release of Lactate
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2021
- Study start11 Feb 2022
- Primary completion16 Nov 2024
- Study completion14 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IschemiaStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Sam Parnia, MD, PhD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04924985
- Sponsor's protocol ID
- 20-00354
- Other IDs
- 1R01HL151732-01
- Status last verified
- Jul 2026
- First submitted
- 10 Jun 2021
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Goal-Directed Cardiopulmonary Resuscitation in Cardiac Arrest Using a Novel Physiological Target
- ClinicalTrials.gov ID
- NCT04924985
- Acronym / sponsor ID
- 20-00354
- Conditions
- Ischemia, Reperfusion Injury
- Keywords
- CPR
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 11 Feb 2022 (actual)
- Primary completion
- 16 Nov 2024 (actual)
- Study completion
- 14 Feb 2025 (actual)
- First posted
- 14 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physiological Feedback CPR | Experimental | Other: Physiological Feedback CPR |
| Non-Physiological (Audiovisual) Feedback CPR | Active comparator | Other: Non-Physiological Feedback CPR |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- In-hospital cardiac arrest patient
- Age ≥18 years
- Age <80 years
- CPR lasting ≥5 minutes
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-Physiological Feedback CPRNon-physiologically guided CPR using AV feedback (integrated into defibrillators) | Other | Non-Physiological (Audiovisual) Feedback CPR |
| Physiological Feedback CPRPhysiological feedback CPR using an optimal regional O2 Saturation (rSO2), End-tidal CO2 (ETCO2) or combined (rSO2/ETCO2) target | Other | Physiological Feedback CPR |
Primary outcome
Rate of Return of Spontaneous Circulation (ROSC)
Time frame: Day 0
6 secondary outcomes
Cerebral Performance Category (CPC) Score
Time frame: Day 1-2
Cerebral Performance Category (CPC) Score
Time frame: Day 30
Change in mean rSO2 during CPR as markers of the quality of resuscitation
Time frame: Day 0
Change in mean ETCO2 during CPR as markers of the quality of resuscitation
Time frame: Day 0
Release of interleukin (IL)-6
Time frame: Day 0
Release of Lactate
Time frame: Day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sam Parnia, MD, PhD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-Physiological Feedback CPR and Physiological Feedback CPR in people with Ischemia and Reperfusion Injury, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Return of Spontaneous Circulation (ROSC) (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.