PRECISION-CPR: PRecision-Controlled Ventilation in CPR

Not Applicable

Not yet recruiting

• Conditions: Cardiac Arrest (CA)

• Registration Number: NCT07088120
• Lead Sponsor: Rush University Medical Center

Brief Summary

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.

Detailed 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.

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-10
• Study First Submitted QC: 2025-07-18
• Last Update Submitted: 2025-07-18
• Study First Posted: 2025-07-28
• Last Update Posted: 2025-07-28
• Study Start: 2025-09-22
• Primary Completion: 2029-09-30
• Study Completion: 2029-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 852

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Return of Spontaneous Circulation (ROSC)	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 Outcome Measures

Name	Time	Method
Survival to Hospital Discharge	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.
Neurological Status at Hospital Discharge	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).
Time to Return of Spontaneous Circulation (ROSC)	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.
Duration of Mechanical Ventilation	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.
Length of ICU Stay	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.
New Occurrence of Pneumothorax During CPR	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.

Trial Locations

Locations (1)

Rush University Medical Center; 🇺🇸 Chicago, Illinois, United States