PRECISION-CPR: PRecision-Controlled Ventilation in CPR

Rush

Status: Begins enrollment this month

Conditions: Cardiac Arrest (CA)

Treatments: Other: Standard Manual Ventilation During CPR; Device: Precision-Controlled Ventilation with Real-Time Feedback

Study type: Interventional

Funder types: Other

Identifiers

NCT07088120

CPR-RCT 001

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 852 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients (18 years or older) with in-hospital cardiac arrest receiving manual ventilation via bag-mask or artificial airway

Exclusion criteria

• Inability to estimate predicted body weight (e.g., extreme body habitus or lack of height data).
• Patients receiving Extracorporeal Membrane Oxygenation (ECMO).
• Known pregnancy.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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852 participants in 2 patient groups

Precision-Controlled Ventilation with Real-Time Feedback

Experimental group

Description:

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.

Treatment:

Device: Precision-Controlled Ventilation with Real-Time Feedback

Standard of Care Ventilation During CPR

Active Comparator group

Description:

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.

Treatment:

Other: Standard Manual Ventilation During CPR