PRECISION-CPR: PRecision-Controlled Ventilation in CPR

Official title

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

Overview

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.

Interventions

• Device Precision-Controlled Ventilation with Real-Time Feedback
  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.
• Other Standard Manual Ventilation During CPR
  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 outcome measures

• Return of Spontaneous Circulation (ROSC) [Time frame: During resuscitation (up to 60 minutes after cardiac arrest onset)]

Secondary outcome measures (6)

• Survival to Hospital Discharge [Time frame: Through hospital discharge (up to 28 days after enrollment)]
• Neurological Status at Hospital Discharge [Time frame: At time of hospital discharge (up to 28 days after CPR event)]
• 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)]
• Duration of Mechanical Ventilation [Time frame: From intubation until extubation or hospital discharge, up to 60 days.]
• Length of ICU Stay [Time frame: From ICU admission until ICU discharge, up to 60 days.]
• New Occurrence of Pneumothorax During CPR [Time frame: During resuscitation (up to 60 minutes after cardiac arrest onset)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

United States · 1 center

• Rush University Medical Center — Chicago

Mexico · 1 center

• Hospital Civil Fray Antonio Alcalde, University of Guadalajara — Guadalajara

Publications

• Kim JW, Park SO, Lee KR, Hong DY, Baek KJ. Efficacy of Amflow(R), a Real-Time-Portable Feedback Device for Delivering Appropriate Ventilation in Critically Ill Patients: A Randomised, Controlled, Cross-Over Simulation Study. Emerg Med Int. 2020 Apr 24;2020:5296519. doi: 10.1155/2020/5296519. eCollection 2020. PMID 32377436
• Lee ED, Jang YD, Kang JH, Seo YS, Yoon YS, Kim YW, Jeong WB, Ji JG. Effect of a Real-Time Audio Ventilation Feedback Device on the Survival Rate and Outcomes of Patients with Out-of-Hospital Cardiac Arrest: A Prospective Randomized Controlled Study. J Clin Med. 2023 Sep 18;12(18):6023. doi: 10.3390/jcm12186023. PMID 37762963
• Drennan IR, Lee M, Heroux JP, Lee A, Riches J, Peppler J, Poitras A, Cheskes S. The impact of real-time feedback on ventilation quality during out-of-hospital cardiac arrest: A before-and-after study. Resuscitation. 2024 Nov;204:110381. doi: 10.1016/j.resuscitation.2024.110381. Epub 2024 Sep 18. PMID 39299509
• Tsao CW, Aday AW, Almarzooq ZI, Alonso A, Beaton AZ, Bittencourt MS, Boehme AK, Buxton AE, Carson AP, Commodore-Mensah Y, Elkind MSV, Evenson KR, Eze-Nliam C, Ferguson JF, Generoso G, Ho JE, Kalani R, Khan SS, Kissela BM, Knutson KL, Levine DA, Lewis TT, Liu J, Loop MS, Ma J, Mussolino ME, Navaneethan SD, Perak AM, Poudel R, Rezk-Hanna M, Roth GA, Schroeder EB, Shah SH, Thacker EL, VanWagner LB, V PMID 35078371
• Algahtani AI, Scott JB, Li J. Ventilation and Oxygenation During and After Adult Cardiopulmonary Resuscitation: Changing Paradigms. Respir Care. 2024 Nov 18;69(12):1573-1586. doi: 10.4187/respcare.12427. PMID 39288964
• Scott JB, Schneider JM, Schneider K, Li J. An evaluation of manual tidal volume and respiratory rate delivery during simulated resuscitation. Am J Emerg Med. 2021 Jul;45:446-450. doi: 10.1016/j.ajem.2020.09.091. Epub 2020 Oct 9. PMID 33077312
• Panchal AR, Bartos JA, Cabanas JG, Donnino MW, Drennan IR, Hirsch KG, Kudenchuk PJ, Kurz MC, Lavonas EJ, Morley PT, O'Neil BJ, Peberdy MA, Rittenberger JC, Rodriguez AJ, Sawyer KN, Berg KM; Adult Basic and Advanced Life Support Writing Group. Part 3: Adult Basic and Advanced Life Support: 2020 American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care PMID 33081529
• Becker LB, Aufderheide TP, Graham R. Strategies to Improve Survival From Cardiac Arrest: A Report From the Institute of Medicine. JAMA. 2015 Jul 21;314(3):223-4. doi: 10.1001/jama.2015.8454. No abstract available. PMID 26132709

Identifiers

NCT: NCT07088120 · CPR-RCT 001

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗