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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two methods of administering CPR to adults experiencing cardiac arrest in the hospital. It compares CPR with a special feedback system that monitors brain oxygen and carbon dioxide levels (Physiological Feedback CPR) to standard CPR using sound and visual cues (Non-Physiological Feedback CPR). The trial aims to determine which method improves survival and neurological recovery. It is suitable for individuals aged 18 to 80 who have experienced cardiac arrest in the hospital and required CPR for at least five minutes. As an unphased trial, it offers participants the chance to contribute to research that could enhance CPR methods and outcomes for future patients.

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 prior data suggests that these CPR methods are safe for cardiac arrest patients?

Research has shown that using feedback about the body's responses during CPR is generally well-tolerated. This method involves monitoring brain oxygen levels to guide CPR efforts. Studies indicate that this approach helps doctors adjust their techniques based on real-time information, potentially improving patient outcomes without introducing new safety concerns.

The other method, non-physiological feedback CPR, employs sounds and visuals to assist during resuscitation. This approach is also considered safe, as it builds on standard CPR techniques already used in hospitals.

No reports have linked major negative effects directly to either feedback method. Both treatments are variations of existing CPR practices, aiming to enhance effectiveness without increasing risk. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative ways to enhance CPR effectiveness during cardiac arrest. Standard CPR methods often rely on fixed guidelines without real-time adjustments. The Physiological Feedback CPR approach stands out because it uses real-time data from the patient's body to tailor the CPR process, potentially improving outcomes by delivering more personalized care. On the other hand, Non-Physiological Feedback CPR uses audiovisual cues to guide rescuers, aiming to improve technique and consistency. This trial could lead to significant advancements in emergency cardiac care by optimizing CPR techniques based on real-time feedback.

What evidence suggests that this trial's treatments could be effective for cardiac arrest?

Research has shown that physiological-feedback CPR, one of the methods tested in this trial, monitors brain oxygen and carbon dioxide levels in real-time and may improve survival and brain health after cardiac arrest. This method aims to keep the brain well-oxygenated during CPR, potentially enhancing the process's effectiveness. Studies indicate that real-time feedback on these measurements can guide better resuscitation efforts. In contrast, non-physiological feedback CPR, another method under study, typically uses sound or visual cues without these specific measurements. While both methods aim to improve CPR outcomes, physiological-feedback CPR might offer more precise guidance by monitoring important brain functions. ^{1 2 3 5 6}

Who Is on the Research Team?

Sam Parnia, MD, PhD

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

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 have undergone CPR for 5 minutes or longer.

Exclusion Criteria

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

I have had 3 or more sudden organ failures.

I have been treated with a heart-lung machine.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04924985

NCT04924985 | Goal-directed CPR Using Cerebral Oximetry Using cerebral oxygenation and end-tidal carbon dioxide physiological targets to predict survival and neurological outcome, the impact of physiological-feedback ...

2. clinicaltrial.be clinicaltrial.be/en/details/42841?per_page=20&recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_recruiting=0&only_eligible=0

Goal-directed CPR Using Cerebral Oximetry - Clinical Tria... The proposed study is a single-center, randomized controlled pilot trial of adults who suffer in-hospital cardiac arrests. Using cerebral ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10912729/

Wolf Creek XVII Part 6: Physiology-Guided CPR - PMC Physiology-guided cardiopulmonary resuscitation (CPR) offers the potential to optimize resuscitation and enable early prognosis.

4. centerwatch.com centerwatch.com/clinical-trials/listings/NCT04924985/goal-directed-cpr-using-cerebral-oximetry

Goal-directed CPR Using Cerebral Oximetry The proposed study is a single-center, randomized controlled pilot trial of adults who suffer in-hospital cardiac arrests. Using cerebral ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S266652042500219X

Cerebral oxygen monitoring during out-of-hospital cardiac ... This non-invasive technique provides real-time measurements of brain oxygenation. The aim of this scoping review (ScR) was to map and describe published studies ...

6. withpower.com withpower.com/trial/goal-directed-cpr-for-cardiac-arrest-90da2

Goal-Directed CPR for Cardiac Arrest · Info for Participants 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 ...