PRECISION-CPR: PRecision-Controlled Ventilation in CPR

NCT07088120 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: CPR-RCT 001
• Study Type: interventional
• Target: 852
• Locations: 2 countries
• Sites: 2

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.

Conditions

Cardiac Arrest (CA)

Keywords

ventilation; tidal volume; cardiac pulmonary resuscitation; real-time feedback; Return of spontaneous circulation

Outcome Measures

Primary Outcomes (1)

• Return of Spontaneous Circulation (ROSC)

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

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

Secondary Outcomes (6)

• Survival to Hospital Discharge

  Through hospital discharge (up to 28 days after enrollment)

• Neurological Status at Hospital Discharge

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

• Time to Return of Spontaneous Circulation (ROSC)

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

• Duration of Mechanical Ventilation

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

• Length of ICU Stay

  From ICU admission until ICU discharge, up to 60 days.

Study Arms (2)

Precision-Controlled Ventilation with Real-Time Feedback

EXPERIMENTAL

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

Standard of Care Ventilation During CPR

ACTIVE COMPARATOR

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

Interventions

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.

Precision-Controlled Ventilation with Real-Time Feedback

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.

Standard of Care Ventilation During CPR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Rush University Medical Center: lead

Study Sites (2)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Hospital Civil Fray Antonio Alcalde, University of Guadalajara

Guadalajara, Jalisco, 44280, Mexico

Location

Related Publications (9)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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, Virani SS, Voecks JH, Wang NY, Yaffe K, Martin SS. Heart Disease and Stroke Statistics-2022 Update: A Report From the American Heart Association. Circulation. 2022 Feb 22;145(8):e153-e639. doi: 10.1161/CIR.0000000000001052. Epub 2022 Jan 26.

  PMID: 35078371 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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. Circulation. 2020 Oct 20;142(16_suppl_2):S366-S468. doi: 10.1161/CIR.0000000000000916. Epub 2020 Oct 21. No abstract available.

  PMID: 33081529 BACKGROUND

• 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 BACKGROUND

• Moskowitz A, Grossestreuer AV, Berg KM, Patel PV, Ganley S, Casasola Medrano M, Cocchi MN, Donnino MW; Center for Resuscitation Science. The association between tidal volume and neurological outcome following in-hospital cardiac arrest. Resuscitation. 2018 Mar;124:106-111. doi: 10.1016/j.resuscitation.2017.12.031. Epub 2017 Dec 29.

  PMID: 29292026 BACKGROUND

MeSH Terms

Conditions

Heart Arrest; Respiratory Aspiration

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

JIE LI, PhD

CONTACT

13125634643; jie_li@rush.edu

Brady Scott, PhD

CONTACT

(312) 942-6389; Jonathan_B_Scott@rush.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Patients will be randomized in a 1:1 ratio to either precision-controlled ventilation with real-time feedback or standard ventilation without feedback during CPR. Both groups will be treated concurrently, and outcomes will be compared between groups using a parallel design across multiple centers.

Study Record Dates

• First Submitted: July 10, 2025
• First Posted: July 28, 2025
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 30, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1); US (1)