Back to resultsGoal-directed CPR Using Cerebral Oximetry
Primary Purpose
Ischemia, Reperfusion Injury
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Non-Physiological Feedback CPR
Physiological Feedback CPR
Sponsored by
About this trial
This is an interventional treatment trial for Ischemia focused on measuring CPR
Eligibility Criteria
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)
Sites / Locations
- NYU Langone HealthRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Physiological Feedback CPR
Non-Physiological (Audiovisual) Feedback CPR
Arm Description
Outcomes
Primary Outcome Measures
Rate of Return of Spontaneous Circulation (ROSC)
Secondary Outcome Measures
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.
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.
Change in mean rSO2 during CPR as markers of the quality of resuscitation
Change in mean ETCO2 during CPR as markers of the quality of resuscitation
Release of interleukin (IL)-6
Release of Lactate
Full Information
NCT ID
NCT04924985
First Posted
June 10, 2021
Last Updated
May 10, 2023
Sponsor
NYU Langone Health
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT04924985
Brief Title
Goal-directed CPR Using Cerebral Oximetry
Official Title
Goal-Directed Cardiopulmonary Resuscitation in Cardiac Arrest Using a Novel Physiological Target
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 11, 2022 (Actual)
Primary Completion Date
July 31, 2025 (Anticipated)
Study Completion Date
July 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemia, Reperfusion Injury
Keywords
CPR
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Physiological Feedback CPR
Arm Type
Experimental
Arm Title
Non-Physiological (Audiovisual) Feedback CPR
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Non-Physiological Feedback CPR
Intervention Description
Non-physiologically guided CPR using AV feedback (integrated into defibrillators)
Intervention Type
Other
Intervention Name(s)
Physiological Feedback CPR
Intervention Description
Physiological feedback CPR using an optimal regional O2 Saturation (rSO2), End-tidal CO2 (ETCO2) or combined (rSO2/ETCO2) target
Primary Outcome Measure Information:
Title
Rate of Return of Spontaneous Circulation (ROSC)
Time Frame
Day 0
Secondary Outcome Measure Information:
Title
Cerebral Performance Category (CPC) Score
Description
Total range of score is 1 (Good cerebral performance) to 5 (Brain death). The higher the score, the worse the clinical condition.
Time Frame
Day 1-2
Title
Cerebral Performance Category (CPC) Score
Description
Total range of score is 1 (Good cerebral performance) to 5 (Brain death). The higher the score, the worse the clinical condition.
Time Frame
Day 30
Title
Change in mean rSO2 during CPR as markers of the quality of resuscitation
Time Frame
Day 0
Title
Change in mean ETCO2 during CPR as markers of the quality of resuscitation
Time Frame
Day 0
Title
Release of interleukin (IL)-6
Time Frame
Day 0
Title
Release of Lactate
Time Frame
Day 0
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anelly Gonzalez
Phone
646-501-6923
Email
Anelly.Gonzales@nyulangone.org
First Name & Middle Initial & Last Name or Official Title & Degree
Natalia Leontovich
Phone
917-518-2529
Email
Natalia.leontovich@nyulangone.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sam Parnia, MD, PhD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anelly Gonzalez
Email
Anelly.Gonzales@nyulangone.org
First Name & Middle Initial & Last Name & Degree
Tara Keshavarz
Email
Tara.Keshavarz@nyulangone.org
First Name & Middle Initial & Last Name & Degree
Sam Parnia, MD, PhD
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Learn more about this trial
Goal-directed CPR Using Cerebral Oximetry
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