- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07431710
The AIR-CPR Study: AI-Guided Chest Compressions (AIR-CPR)
Utilizing Artificial Intelligence to Optimize Chest Compression Region During Cardio-pulmonary Resuscitation for Patients With Out-of-hospital Cardiac Arrest.
The AIR-CPR project aims to improve survival rates for patients with Out-of-Hospital Cardiac Arrest (OHCA) by utilizing Artificial Intelligence (AI) to optimize chest compression locations. Current guidelines recommend a standardized compression point (the lower half of the sternum), yet recent research indicates that this position can compress the aortic valve in approximately 48.7% of patients, significantly reducing the chances of successful resuscitation.
This study will develop a deep learning model based on YOLO v8 to analyze real-time arterial pressure waveforms to identify proper aortic valve opening and closing. By identifying specific waveform features that humans cannot easily distinguish, the AI will guide rescuers to adjust the compression site-typically toward the left ventricle-to ensure optimal blood output. The project seeks to transform CPR from a standardized "one-size-fits-all" approach into a personalized, precision medicine intervention.
Study Overview
Status
Conditions
Detailed Description
This three-year prospective study is designed to develop and clinically validate an "AI-Enhanced Arterial Waveform Monitor" to guide precision CPR.
- Research Hypothesis and Objectives The study tests the hypothesis that AI can accurately predict aortic valve compression (confirmed by Transesophageal Echocardiography, TEE) by analyzing arterial pressure waveforms, thereby allowing rescuers to find the optimal compression site that avoids the aortic valve and maximizes cardiac output.
Implementation Phases
The project is divided into five distinct stages:
Case Preparation: Enrollment of 150 OHCA patients to collect synchronized TEE video and arterial pressure data.
Arterial Waveform Detection Model: Development of an algorithm to automatically segment continuous pressure signals into single-compression waveform samples.
Compression Region Detection Model: Training a YOLO v8-based model integrated with patient physiological data (age, sex, medical history) to distinguish between "compressed" and "non-compressed" aortic valve states.
Clinical External Testing: Enrolling an additional 75 patients to verify model accuracy against TEE "gold standard" findings.
Feasibility Assessment: Deploying the model as a "Resuscitation Support App" in 30 real-world clinical cases to evaluate its real-time guidance capability, speed, and impact on patient outcomes.
Technical Methodology
Data Extraction: Using binarization and interpolation curve fitting to extract high-quality numerical data directly from physiological monitor screens.
AI Architecture: Utilizing an improved YOLO v8 framework combined with an Attention-based architecture and Fully-connected neural networks to incorporate complex patient heterogeneities.
Clinical Intervention: When the AI identifies aortic valve compression, rescuers will be prompted to adjust the compression location (typically downward and to the left) until the valve is no longer obstructed.
- Outcome Measures The study will evaluate the Identification Success Rate (AI vs. TEE), Avoidance Success Rate (successful repositioning), and traditional resuscitation metrics including ROSC, survival to discharge, and favorable neurologic outcomes.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Sheng-En Chu, physician
- Phone Number: 886-2-7728-1843
- Email: ianchu300@msn.com
Study Locations
-
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Banqiao
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New Taipei City, Banqiao, Taiwan, 220
- Recruiting
- Far Eastern Memorinal Hospital
-
Contact:
- Sheng-En Chu, physician
- Phone Number: 886-2-77281843
- Email: ianchu300@msn.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adults aged 20 years or older.
- Patients with out-of-hospital cardiac arrest (OHCA) undergoing 3.cardiopulmonary resuscitation (CPR) in the emergency department.
Cardiac arrest caused by non-traumatic factors.
Exclusion Criteria:
- Pregnant patients.
- Patients with obvious signs of death.
- Patients with a signed "Do Not Resuscitate" (DNR) order.
- Patients requiring extracorporeal cardio-pulmonary resuscitation (ECPR).
- Patients requiring Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA).
- Cardiac arrest caused by massive hemorrhage, aortic emergencies, tension pneumothorax, cardiac tamponade, or pulmonary embolism.
- History of severe aortic valve disease or previous aortic valve surgery.
- Patients for whom TEE or femoral arterial catheterization is contraindicated.
- Situations where the medical team is unable to perform TEE or femoral arterial catheterization during CPR.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
OHCA Patients Receiving AI-Enhanced Resuscitation.
Adult patients (20 years or older) with non-traumatic Out-of-Hospital Cardiac Arrest (OHCA) who receive Advanced Life Support (ALS) at the Far Eastern Memorial Hospital Emergency Department.
This cohort provides the data for AI training (Years 1-2) and participates in the clinical validation of the AI-guided compression technique (Year 3).
|
A deep learning application based on the YOLO v8 architecture that analyzes real-time arterial pressure waveforms from a femoral A-line.
It identifies whether the current chest compression location is causing aortic valve compression (as confirmed by TEE) and provides immediate feedback to the resuscitation team.
When the AI application indicates aortic valve compression, the rescuer adjusts the mechanical chest compression (LUCAS) position.
Based on literature and AI feedback, the adjustment typically involves moving the compression point downward and toward the left parasternal line to avoid the aortic valve and optimize left ventricular output.
Used as the "Gold Standard" throughout the study.
TEE is performed during CPR to record the actual opening and closing of the aortic valve and the deformation of cardiac chambers, providing the labels for AI training and the verification for clinical testing.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
AI Identification Accuracy of Aortic Valve Compression
Time Frame: Collected during the clinical testing phase and feasibility assessment (Years 2 and 3).
|
The accuracy of the AI model in identifying whether the aortic valve is compressed or open during CPR, using Transesophageal Echocardiography (TEE) as the gold standard for verification.
|
Collected during the clinical testing phase and feasibility assessment (Years 2 and 3).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Successful Avoidance of Aortic Valve Compression
Time Frame: During the clinical feasibility assessment (Year 3).
|
The percentage of cases where the resuscitation team successfully adjusted the chest compression location to stop aortic valve compression based on AI app feedback, confirmed by TEE.
|
During the clinical feasibility assessment (Year 3).
|
|
Time Consumed for Compression Adjustment
Time Frame: During the clinical feasibility assessment (Year 3).
|
The time interval between the first arterial waveform detection and the completion of the chest compression repositioning.
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During the clinical feasibility assessment (Year 3).
|
|
Rate of Return of Spontaneous Circulation (ROSC)
Time Frame: From the start of the emergency department resuscitation until hospital discharge or death (up to approximately 30 days).
|
Incidence of ROSC and sustained ROSC (maintained for $\ge 20$ minutes), as well as survival rates to hospital admission and discharge.
|
From the start of the emergency department resuscitation until hospital discharge or death (up to approximately 30 days).
|
|
Favorable Neurologic Outcome at Discharge
Time Frame: At the time of hospital discharge (up to approximately 30 days).
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Assessment of neurological status using the Cerebral Performance Category (CPC 1-2) or Modified Rankin Scale (mRS 0-2).
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At the time of hospital discharge (up to approximately 30 days).
|
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Chest Compression Fraction (CCF)
Time Frame: During the clinical feasibility assessment (Year 3).
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The proportion of total resuscitation time during which chest compressions were performed, ensuring that AI-guided adjustments do not negatively impact the continuity of compressions.
|
During the clinical feasibility assessment (Year 3).
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
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Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Heart Diseases
- Heart Arrest
- Out-of-Hospital Cardiac Arrest
- Diagnostic Techniques and Procedures
- Diagnosis
- Diagnostic Imaging
- Diagnostic Techniques, Cardiovascular
- Heart Function Tests
- Echocardiography
- Cardiac Imaging Techniques
- Ultrasonography
- Echocardiography, Transesophageal
Other Study ID Numbers
- 113046-F
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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