Goal-directed CPR Using Cerebral Oximetry

Ischemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04924985
• Other study ID #: 20-00354
• Secondary ID: 1R01HL151732-01
• Status: Recruiting
• Phase: N/A
• Start date: February 11, 2022
• Est. completion date: July 31, 2025

Study information

• Verified date: April 2024
• Source: NYU Langone Health
• Contact: Anelly Gonzalez
• Phone: 646-501-6923
• Email: Anelly.Gonzales[@]nyulangone.org
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: July 31, 2025
• Est. primary completion date: July 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Ischemia
• Reperfusion Injury

Intervention

Other:
• Non-Physiological Feedback CPR
Non-physiologically guided CPR using AV feedback (integrated into defibrillators)
• Physiological Feedback CPR
Physiological feedback CPR using an optimal regional O2 Saturation (rSO2), End-tidal CO2 (ETCO2) or combined (rSO2/ETCO2) target

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
NYU Langone Health	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Return of Spontaneous Circulation (ROSC)		Day 0
Secondary	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
Secondary	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
Secondary	Change in mean rSO2 during CPR as markers of the quality of resuscitation		Day 0
Secondary	Change in mean ETCO2 during CPR as markers of the quality of resuscitation		Day 0
Secondary	Release of interleukin (IL)-6		Day 0
Secondary	Release of Lactate		Day 0