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OpenTrials
Completed

NCT Number: NCT04924985

Goal-directed CPR Using Cerebral Oximetry

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone Health

New York, 10016, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Non-Physiological Feedback CPR

Other

Non-physiologically guided CPR using AV feedback (integrated into defibrillators)

Physiological Feedback CPR

Other

Physiological feedback CPR using an optimal regional O2 Saturation (rSO2), End-tidal CO2 (ETCO2) or combined (rSO2/ETCO2) target

Primary outcomes

  1. Rate of Return of Spontaneous Circulation (ROSC)

    Time frame: Day 0

Secondary outcomes

  1. Cerebral Performance Category (CPC) Score

    Time frame: 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.

  2. Cerebral Performance Category (CPC) Score

    Time frame: Day 30

    Total range of score is 1 (Good cerebral performance) to 5 (Brain death). The higher the score, the worse the clinical condition.

  3. Change in mean rSO2 during CPR as markers of the quality of resuscitation

    Time frame: Day 0

  4. Change in mean ETCO2 during CPR as markers of the quality of resuscitation

    Time frame: Day 0

  5. Release of interleukin (IL)-6

    Time frame: Day 0

  6. Release of Lactate

    Time frame: Day 0

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Jun 14, 2021
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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