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NCT Number: NCT07088120

PRECISION-CPR: PRecision-Controlled Ventilation in CPR

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.

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Key information

Conditions

Cardiac Arrest (CA) Cardiovascular Diseases Heart Arrest Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Aspiration Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Civil Fray Antonio Alcalde, University of Guadalajara, Guadalajara, Jalisco, Mexico

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Precision-Controlled Ventilation with Real-Time Feedback

Device

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.

Standard Manual Ventilation During CPR

Other

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.

Primary outcomes

  1. Return of Spontaneous Circulation (ROSC)

    Time frame: During resuscitation (up to 60 minutes after cardiac arrest onset)

    Documented presence of a palpable pulse and measurable blood pressure during resuscitation after initiation of CPR.

Secondary outcomes

  1. Survival to Hospital Discharge

    Time frame: Through hospital discharge (up to 28 days after enrollment)

    Survival of the patient to hospital discharge following the index cardiac arrest event during which CPR and the study intervention were delivered.

  2. Neurological Status at Hospital Discharge

    Time frame: At time of hospital discharge (up to 28 days after CPR event)

    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).

  3. Time to Return of Spontaneous Circulation (ROSC)

    Time frame: From initiation of CPR to termination of resuscitation efforts (up to 60 minutes after CPR initiation)

    Time interval from initiation of CPR to achievement of documented ROSC, defined as the presence of a palpable pulse and measurable blood pressure.

  4. Duration of Mechanical Ventilation

    Time frame: From intubation until extubation or hospital discharge, up to 60 days.

    Total number of days the patient receives invasive mechanical ventilation during the index hospitalization following cardiac arrest.

  5. Length of ICU Stay

    Time frame: From ICU admission until ICU discharge, up to 60 days.

    Total length of stay in the intensive care unit during the index hospitalization following cardiac arrest.

  6. New Occurrence of Pneumothorax During CPR

    Time frame: During resuscitation (up to 60 minutes after cardiac arrest onset)

    Incidence of newly diagnosed pneumothorax occurring during CPR and resuscitation efforts, confirmed by clinical assessment and imaging if available.

Study contacts

Contact information is provided by the study sponsor or research team.

Brady Scott, PhD

CONTACT

[email protected]

(312) 942-6389

JIE LI, PhD

CONTACT

[email protected]

13125634643

Sponsors and collaborators

Lead sponsor

Rush University Medical Center

Other

Registry information

Official study title

PRecision-Controlled Ventilation to Enhance Cardiac Arrest Intervention and Survival IN CPR: A Multi-Center Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Jul 28, 2025
Registry last updated
Mar 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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