An interventional study of Precision-Controlled Ventilation with Real-Time Feedback and Standard Manual Ventilation During CPR in Cardiac Arrest (CA), sponsored by Rush University Medical Center. Not yet recruiting at 2 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-11.
Sponsored by Rush University Medical Center · Not applicable, Interventional, and Treatment
Cardiac arrest is a life-threatening emergency that requires immediate treatment with cardiopulmonary resuscitation (CPR). While chest compressions circulate blood, manual ventilation provides oxygen to the patient. Current CPR guidelines recommend specific ventilation rates and tidal volumes, but studies show that clinicians often deliver too much or too little ventilation due to a lack of monitoring tools, potentially reducing the effectiveness of CPR and impacting survival.
The PRECISION-CPR study is a multi-center, randomized controlled trial designed to evaluate whether using real-time feedback devices to precisely control ventilation during CPR can improve patient outcomes. Adult patients experiencing in-hospital cardiac arrest will be randomized to receive either standard manual ventilation guided by clinician experience or precision-controlled ventilation tailored to the patient's predicted body weight using real-time monitoring devices.
The primary outcome of the study will be return of spontaneous circulation (ROSC). Secondary outcomes will include survival to hospital discharge, neurological recovery, and other clinical measures. By addressing the limitations of current ventilation practices, this study aims to generate evidence to guide future resuscitation guidelines and improve survival rates after cardiac arrest.
The PRECISION-CPR trial is a prospective, multi-center, randomized controlled trial evaluating the effect of precision-controlled ventilation on outcomes during cardiopulmonary resuscitation (CPR) in adult in-hospital cardiac arrest. The study aims to determine whether the use of real-time feedback devices to guide tidal volume (6-8 mL/kg predicted body weight) and respiratory rate (10 breaths per minute) improves return of spontaneous circulation (ROSC) and other clinical outcomes.
Participants are randomized 1:1 to either:
Intervention Group: Manual ventilation guided by real-time feedback device providing continuous tidal volume and respiratory rate feedback during CPR.
Control Group: Manual ventilation performed per standard care without feedback, with the same devices used in blinded mode to record but not display ventilation data.
Ventilation parameters are recorded breath-by-breath. Hemodynamic and clinical variables (e.g., heart rate, end-tidal CO₂) are obtained from the electronic medical record and time-synchronized with ventilation data. Data are collected in REDCap and monitored by a central coordinating center. A Data Safety Monitoring Board oversees safety, protocol adherence, and interim analyses.
The study uses a parallel assignment model and includes stratified randomization by center. Detailed eligibility criteria and outcome measures are recorded in their respective ClinicalTrials.gov sections. The trial is powered to detect differences in ROSC and includes prespecified secondary outcomes and subgroup analyses. The protocol includes quality assurance procedures, interim analyses, and real-time feedback training for clinical teams to ensure intervention fidelity.
966 studies on the registry are indexed under Heart Arrest; 227 are open to participants now.
This study's planned enrollment of 852 is above the median of 100 across 557 interventional studies indexed under Heart Arrest.
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Exclusion Criteria:
Patients will receive manual ventilation during CPR using real-time feedback devices (EOlife) to guide tidal volume (6-8 mL/kg predicted body weight) and ventilation rate (10 breaths per minute) delivery, ensuring adherence to guideline-recommended ventilation parameters.
Device: Precision-Controlled Ventilation with Real-Time Feedback
Patients will receive manual ventilation during CPR per standard practice without real-time feedback, using clinician judgment for tidal volume (visible chest rise) and ventilation rate, consistent with American Heart Association guidelines.
Other: Standard Manual Ventilation During CPR
Manual ventilation during CPR using a real-time feedback device (EOlife, Archeon Medical) to guide the delivery of tidal volumes (6-8 mL/kg predicted body weight) and ventilation rate (10 breaths per minute). The device measures and displays ventilation parameters in real time, helping providers achieve guideline-recommended targets during resuscitation.
Manual ventilation during CPR without real-time feedback, using clinician judgment to guide tidal volume (visible chest rise) and ventilation rate, consistent with American Heart Association guidelines.
Return of Spontaneous Circulation (ROSC)
Documented presence of a palpable pulse and measurable blood pressure during resuscitation after initiation of CPR.
Time frame: During resuscitation (up to 60 minutes after cardiac arrest onset)
Survival to Hospital Discharge
Survival of the patient to hospital discharge following the index cardiac arrest event during which CPR and the study intervention were delivered.
Time frame: Through hospital discharge (up to 28 days after enrollment)
Neurological Status at Hospital Discharge
Neurological function assessed using the Cerebral Performance Category (CPC) score at the time of hospital discharge, categorized as favorable (CPC 1-2) or unfavorable (CPC 3-5).
Time frame: At time of hospital discharge (up to 28 days after CPR event)
Time to Return of Spontaneous Circulation (ROSC)
Time interval from initiation of CPR to achievement of documented ROSC, defined as the presence of a palpable pulse and measurable blood pressure.
Time frame: From initiation of CPR to termination of resuscitation efforts (up to 60 minutes after CPR initiation)
Duration of Mechanical Ventilation
Total number of days the patient receives invasive mechanical ventilation during the index hospitalization following cardiac arrest.
Time frame: From intubation until extubation or hospital discharge, up to 60 days.
Length of ICU Stay
Total length of stay in the intensive care unit during the index hospitalization following cardiac arrest.
Time frame: From ICU admission until ICU discharge, up to 60 days.
New Occurrence of Pneumothorax During CPR
Incidence of newly diagnosed pneumothorax occurring during CPR and resuscitation efforts, confirmed by clinical assessment and imaging if available.
Time frame: During resuscitation (up to 60 minutes after cardiac arrest onset)
Plan to share: No — We do not plan to share individual participant data (IPD) outside the study team due to institutional policies, data privacy regulations, and the sensitive nature of cardiac arrest data. Aggregate de-identified results will be disseminated through peer-reviewed publications and presentations.
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