Goal-directed CPR Using Cerebral Oximetry

NCT ID: NCT04924985

Last Updated: 2025-03-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-11

Study Completion Date

2025-07-31

Brief Summary

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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

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Conditions

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Ischemia Reperfusion Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Physiological Feedback CPR

Group Type EXPERIMENTAL

Physiological Feedback CPR

Intervention Type OTHER

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

Non-Physiological (Audiovisual) Feedback CPR

Group Type ACTIVE_COMPARATOR

Non-Physiological Feedback CPR

Intervention Type OTHER

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

Interventions

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Non-Physiological Feedback CPR

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

Intervention Type OTHER

Physiological Feedback CPR

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

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sam Parnia, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

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NYU Langone Health

New York, New York, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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1R01HL151732-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

20-00354

Identifier Type: -

Identifier Source: org_study_id

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