Goal-directed CPR Using Cerebral Oximetry

Not Applicable

Active, not recruiting

• Conditions: Ischemia; Reperfusion Injury
• Interventions: Other: Non-Physiological Feedback CPR; Other: Physiological Feedback CPR

• Registration Number: NCT04924985
• Lead Sponsor: NYU Langone Health

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-06-10
• Study First Submitted QC: 2021-06-11
• Study First Posted: 2021-06-14
• Study Start: 2022-02-11
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-24
• Last Update Posted: 2025-03-27
• Primary Completion: 2025-07-31
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non-Physiological (Audiovisual) Feedback CPR	Non-Physiological Feedback CPR	-
Physiological Feedback CPR	Physiological Feedback CPR	-

Primary Outcome Measures

Name	Time	Method
Rate of Return of Spontaneous Circulation (ROSC)	Day 0

Secondary Outcome Measures

Name	Time	Method
Release of Lactate	Day 0
Release of interleukin (IL)-6	Day 0
Cerebral Performance Category (CPC) Score	Day 30	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	Day 0
Change in mean ETCO2 during CPR as markers of the quality of resuscitation	Day 0

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States