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PRECISION-CPR: PRecision-Controlled Ventilation in CPR

ConditionCardiac Arrest (CA)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRush University Medical Center

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

  • 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 intervention

    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.

Treatment groups

852 Participants
are divided into 2 treatment groups
Group A: Precision-Controlled Ventilation with Real-Time FeedbackExperimental treatment 1 intervention
Group B: Standard of Care Ventilation During CPRActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Return of Spontaneous Circulation (ROSC)

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

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

Secondary outcomes

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.

Time frame
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).

Time frame
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.

Time frame
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.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Rush University Medical Center

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: