Goal-Directed CPR for Cardiac Arrest

Overseen By Natalia Leontovich

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Disqualifiers: Age, Organ failures, Brain injury, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Immediate during cardiac arrest

150 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Goal-Directed CPR for Cardiac Arrest?

Research shows that real-time feedback during CPR can improve the quality of the procedure, which is crucial for patient survival. Studies indicate that using feedback, whether through devices or human input, enhances CPR performance, suggesting that Goal-Directed CPR, which incorporates feedback, could be more effective. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment Goal-Directed CPR for Cardiac Arrest?

Research shows that real-time feedback during CPR can improve the quality of the procedure, which is crucial for patient survival. Studies indicate that both real-time and post-event feedback can enhance CPR performance, suggesting that feedback-guided CPR, like Goal-Directed CPR, may be more effective than standard methods. ^{1 2 3 4 5}

Is Goal-Directed CPR generally safe for humans?

The research articles provided focus on the effectiveness of feedback systems in improving CPR performance, but they do not specifically address the safety of Goal-Directed CPR or related methods in humans. ^{1 4 6 7 8}

How is Goal-Directed CPR for Cardiac Arrest different from other treatments?

Goal-Directed CPR for Cardiac Arrest is unique because it uses real-time feedback and cerebral oximetry (a method to measure oxygen levels in the brain) to guide CPR, aiming to improve the quality of chest compressions and patient outcomes compared to standard CPR methods. ^{1 2 3 5 9}

How is Goal-Directed CPR for Cardiac Arrest different from other treatments?

Goal-Directed CPR for Cardiac Arrest is unique because it uses real-time feedback, including physiological data like cerebral oximetry (a measure of brain oxygen levels), to guide CPR efforts. This approach aims to improve the quality of CPR by providing immediate information to adjust techniques, potentially leading to better patient outcomes compared to standard CPR methods without such feedback. ^{1 2 3 5 9}

Research Team

Sam Parnia, MD, PhD

Principal Investigator

NYU Langone Health

Eligibility Criteria

This trial is for adults aged 18-80 who experience a cardiac arrest inside NYU Tisch Hospital and require CPR for at least 5 minutes. It's not open to those with more than two acute organ failures, previous recent cardiac arrests, or certain brain conditions.

Inclusion Criteria

I am younger than 80 years old.

You recently had a cardiac arrest while in the hospital.

I am 18 years old or older.

Exclusion Criteria

I am between 18 and 80 years old.

People who have had a heart attack outside of the hospital.

I have had 3 or more sudden organ failures.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either Physiological-Feedback CPR or Non-Physiological (Audiovisual) Feedback CPR during cardiac arrest events

Immediate during cardiac arrest

Follow-up

Participants are monitored for survival and neurological outcomes, including assessment of Cerebral Performance Category (CPC) Score

30 days

Treatment Details

Interventions

• Non-Physiological Feedback CPR
• Physiological Feedback CPR

Trial Overview The study compares two types of CPR in a hospital setting: one using physiological feedback based on cerebral oxygen levels and another using non-physiological audiovisual cues to guide resuscitation efforts.

Participant Groups

Group I: Physiological Feedback CPR Experimental Treatment 1 Intervention

Group II: Non-Physiological (Audiovisual) Feedback CPR Active Control 1 Intervention

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Findings from Research

Real-time objective feedback during CPR training significantly improved CPR performance among pre-hospital professionals, with a notable enhancement in infant assessment skills.

Competition between EMS organizations and participants motivated staff to practice more, indicating that incorporating competitive elements into training could further enhance CPR training effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does real-time objective feedback and competition improve performance and quality in manikin CPR training--a prospective observational study from several European EMS. Smart, JR., Kranz, K., Carmona, F., et al.[2018]

Real-time feedback during CPR significantly improves the quality of chest compressions, specifically in terms of depth and rate, while post-event feedback enhances compression depth and fraction.

Although neither type of feedback statistically improved patient outcomes in out-of-hospital cardiac arrest cases, there was a clinical effect observed, suggesting that combining both feedback methods could enhance CPR quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of real-time and post-event feedback in out-of-hospital cardiac arrest attended by EMS - A systematic review and meta-analysis. Lyngby, RM., Händel, MN., Christensen, AM., et al.[2022]

Recent evidence shows that the quality of CPR significantly impacts survival rates in cardiac arrest victims, highlighting the importance of effective CPR delivery.

Various strategies, including real-time feedback, physiological monitoring, and mechanical CPR devices, have been evaluated to enhance CPR performance, suggesting that a combination of these methods may improve outcomes in both prehospital and in-hospital settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The importance of cardiopulmonary resuscitation quality. Abella, BS.[2022]

In a study involving 326 medical students, the quality of CPR performed with human feedback was found to be comparable to that performed with a mechanical feedback device, indicating that both methods can effectively guide CPR performance.

Human feedback led to quicker initiation of chest compressions and fewer incorrect decompressions compared to the mechanical device, suggesting that verbal guidance can enhance certain aspects of CPR execution.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short structured feedback training is equivalent to a mechanical feedback device in two-rescuer BLS: a randomised simulation study. Pavo, N., Goliasch, G., Nierscher, FJ., et al.[2018]

A study analyzing 45 CPR cases showed that regular feedback from video recordings significantly improved CPR quality, with chest compression rates exceeding 110 compressions per minute in 75% of cases.

The time delay to the first chest compression improved significantly over the study period, indicating that real-time feedback can enhance the promptness and effectiveness of CPR interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving cardiopulmonary resuscitation in the emergency department by real-time video recording and regular feedback learning. Jiang, C., Zhao, Y., Chen, Z., et al.[2022]

Visual feedback during CPR significantly improved the quality of chest compressions, achieving 78.1% correct compressions compared to 65.4% with auditory feedback and only 44.5% with no feedback, based on a study with 15 female volunteers performing CPR for 10 minutes under different feedback conditions.

While auditory feedback resulted in lower blood lactate levels, indicating less fatigue, visual feedback was more effective overall in maintaining compression depth and rate, suggesting that continuous visual cues may be the best approach to enhance CPR performance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A counterbalanced cross-over study of the effects of visual, auditory and no feedback on performance measures in a simulated cardiopulmonary resuscitation. Cason, CL., Trowbridge, C., Baxley, SM., et al.[2021]

The use of a real-time feedback system during CPR significantly improved the quality of chest compressions, particularly in reducing pauses and increasing compression frequency, with guideline-recommended rates achieved in the final group of participants.

While the overall compression depth did not change significantly with real-time feedback, the proportion of compressions meeting the recommended depth increased notably, indicating that feedback systems can enhance adherence to CPR guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-time feedback improves chest compression quality in out-of-hospital cardiac arrest: A prospective cohort study. Lakomek, F., Lukas, RP., Brinkrolf, P., et al.[2020]

Instantaneous audiovisual feedback during chest compressions significantly improves the quality of compressions, including depth, hand placement, and recoil, as demonstrated in a study involving 200 health care providers and medical students.

However, these improvements are not retained after one year, suggesting that while feedback is effective for immediate training, ongoing practice and training frequency are crucial for maintaining skills.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immediate and 1-year chest compression quality: effect of instantaneous feedback in simulated cardiac arrest. Griffin, P., Cooper, C., Glick, J., et al.[2018]

A large-scale trial involving 2850 to 3020 patients over 4 years will evaluate the effectiveness of a CPR feedback device that provides real-time monitoring and training for emergency medical services (EMS) personnel during cardiac arrest situations.

The primary goal is to determine if this real-time feedback approach improves 1-month favorable neurological survival compared to conventional CPR methods, potentially leading to better patient outcomes after cardiac arrest.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-time feedback, debriefing, and retraining system of cardiopulmonary resuscitation for out-of-hospital cardiac arrests: a study protocol for a cluster parallel-group randomized controlled trial. Hirakawa, A., Hatakeyama, T., Kobayashi, D., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Does real-time objective feedback and competition improve performance and quality in manikin CPR training--a prospective observational study from several European EMS. [2018]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Effect of real-time and post-event feedback in out-of-hospital cardiac arrest attended by EMS - A systematic review and meta-analysis. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

The importance of cardiopulmonary resuscitation quality. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Short structured feedback training is equivalent to a mechanical feedback device in two-rescuer BLS: a randomised simulation study. [2018]

5. Ireland pubmed.ncbi.nlm.nih.gov

Improving cardiopulmonary resuscitation in the emergency department by real-time video recording and regular feedback learning. [2022]

6. England pubmed.ncbi.nlm.nih.gov

A counterbalanced cross-over study of the effects of visual, auditory and no feedback on performance measures in a simulated cardiopulmonary resuscitation. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Real-time feedback improves chest compression quality in out-of-hospital cardiac arrest: A prospective cohort study. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Immediate and 1-year chest compression quality: effect of instantaneous feedback in simulated cardiac arrest. [2018]

9. England pubmed.ncbi.nlm.nih.gov

Real-time feedback, debriefing, and retraining system of cardiopulmonary resuscitation for out-of-hospital cardiac arrests: a study protocol for a cluster parallel-group randomized controlled trial. [2022]