Goal-directed CPR Using Cerebral Oximetry

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.

Study Overview

• Status: Recruiting
• Conditions: Ischemia; Reperfusion Injury
• Intervention / Treatment: Other: Physiological Feedback CPR; Other: Non-Physiological Feedback CPR

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anelly Gonzalez; Phone Number: 646-501-6923; Email: Anelly.Gonzales@nyulangone.org
• Study Contact Backup: Name: Natalia Leontovich; Phone Number: 917-518-2529; Email: Natalia.leontovich@nyulangone.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • Recruiting
      • NYU Langone Health
      • Contact: Anelly Gonzalez; Email: Anelly.Gonzales@nyulangone.org
      • Contact: Tara Keshavarz; Email: Tara.Keshavarz@nyulangone.org
      • Principal Investigator: Sam Parnia, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Physiological Feedback CPR	Other: Physiological Feedback CPR; Physiological feedback CPR using an optimal regional O2 Saturation (rSO2), End-tidal CO2 (ETCO2) or combined (rSO2/ETCO2) target
Active Comparator: Non-Physiological (Audiovisual) Feedback CPR	Other: Non-Physiological Feedback CPR; Non-physiologically guided CPR using AV feedback (integrated into defibrillators)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rate of Return of Spontaneous Circulation (ROSC)	Day 0

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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
Release of Lactate		Day 0

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Sam Parnia, MD, PhD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): February 11, 2022
• Primary Completion (Estimated): July 31, 2025
• Study Completion (Estimated): July 31, 2025

Study Registration Dates

• First Submitted: June 10, 2021
• First Submitted That Met QC Criteria: June 11, 2021
• First Posted (Actual): June 14, 2021

Study Record Updates

• Last Update Posted (Actual): April 5, 2024
• Last Update Submitted That Met QC Criteria: April 3, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: CPR
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Postoperative Complications; Ischemia; Reperfusion Injury
• Other Study ID Numbers: 20-00354; 1R01HL151732-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.
• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No