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Cardiac Arrest (CA)NCT07088120

PRECISION-CPR: PRecision-Controlled Ventilation in CPR

A study testing Standard Manual Ventilation During CPR in people with Cardiac Arrest (CA), run by Rush University Medical Center at 2 sites in 2 countries.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cardiac Arrest (CA)
What is being tested?
Standard Manual Ventilation During CPR
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
852 participants
Where
2 sitesin 2 countries
Study dates
1 Sep 2026to 31 Dec 2030
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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 locations and contacts

2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

2 sites in 2 countries

United States1 site
  • Rush University Medical Center

    Chicago, Illinois, 60612

    JIE LI, PhD, 312-563-4643, jie_li@rush.edu

Other trials in United States

Mexico1 site
  • Hospital Civil Fray Antonio Alcalde, University of Guadalajara

    Guadalajara, Jalisco, 44280

    Miguel Ibarra-Estrada, MD

Other trials in Mexico

About this study

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

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.

Read the 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.

Being tested
Precision-Controlled Ventilation with Real-Time Feedback, Standard Manual Ventilation During CPR
Keywords
ventilation, tidal volume, cardiac pulmonary resuscitation, real-time feedback, Return of spontaneous circulation
Medical subject headings
Heart Arrest, Respiratory Aspiration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Precision-Controlled Ventilation with Real-Time FeedbackDevice

    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 CPROther

    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.

Study groups in NCT07088120
Study groupRoleWhat they receive
Precision-Controlled Ventilation with Real-Time FeedbackExperimentalPatients 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.
Receives: Device: Precision-Controlled Ventilation with Real-Time Feedback
Standard of Care Ventilation During CPRActive comparatorPatients 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.
Receives: Other: Standard Manual Ventilation During CPR

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Return of Spontaneous Circulation (ROSC)

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

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

Secondary outcomes (6)
  1. Survival to Hospital Discharge

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

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

  2. Neurological Status at Hospital Discharge

    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).

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

  3. Time to Return of Spontaneous Circulation (ROSC)

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

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

  4. Duration of Mechanical Ventilation

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

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

  5. Length of ICU Stay

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

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

  6. New Occurrence of Pneumothorax During CPR

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jul 2025
  2. Study start1 Sep 2026 (estimated)
  3. Primary completion30 Sep 2030 (estimated)
  4. Study completion31 Dec 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
852 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07088120
Sponsor's protocol ID
CPR-RCT 001
Status last verified
Mar 2026
First submitted
10 Jul 2025
Last updated
11 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No: We do not plan to share individual participant data (IPD) outside the study team due to institutional policies, data privacy regulations, and the sensitive nature of cardiac arrest data. Aggregate de-identified results will be disseminated through peer-reviewed publications and presentations.

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.

    PubMed 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.

    PubMed 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.

    PubMed 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, 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.

    PubMed 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.

    PubMed 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.

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

    PubMed 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.

    PubMed 26132709
  • 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.

    PubMed 29292026

Questions about this trial

What is this clinical trial studying?

A study testing Standard Manual Ventilation During CPR in people with Cardiac Arrest (CA), run by Rush University Medical Center at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States, Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact JIE LI, PhD (13125634643, jie_li@rush.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Return of Spontaneous Circulation (ROSC) (time frame: During resuscitation (up to 60 minutes after cardiac arrest onset)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07088120, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2026.

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