Cardiac Arrest, Out-Of-HospitalNCT07897370
Cardiac Arrest - Ultrasound Detection of Occult Perfusion
An observational study of Cardiac Arrest, Out-Of-Hospital and Hypotension, run by University of Massachusetts, Worcester at 8 sites in United States.
Trial summary
The goal of this study is to describe the population of patients presenting after out of hospital cardiac arrest with occult perfusion, defined as a patient without a palpable pulse but with some evidence of pulsatile arterial flow. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrest, Out-Of-Hospital, Hypotension
- Type of treatment
- Injection or infusion
- How many people
- 1,400 participants
- Where
- 8 sitesUnited States
- Study dates
- 1 Oct 2026to 1 Oct 2029
- Phase
- Observational
- 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
Study population: All patients presenting to the emergency department following atraumatic cardiac arrest with ongoing resuscitation will be considered for enrollment.
Who may be able to join
- Patients presenting following out-of-hospital atraumatic cardiac arrest
Who cannot join
- Resuscitation ended due to end-of-life decisions
- Documented allergy to ultrasound gel
- Technical malfunction of ultrasound machine during imaging that prevents use
- Ultrasound machine unable to record images
- Cardiac Ultrasound not performed during first, second or third pause in CPR AND vascular Ultrasound not performed during first, second or third pause in CPR
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
United States8 sites, 8 recruiting
- Not yet recruiting
UH Cleveland Medical Center
Cleveland, Ohio, 44106
Aaron Caine, MD, 216-844-1000, acain1@metrohealth.org
- Not yet recruiting
Denver Health
Denver, Colorado, 80204
Matthew Risciniti, MD, 303-436-6000, Matthew.Riscinti@dhha.org
- Not yet recruiting
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Zachary Soucey, MD, Zachary.P.Soucy@hitchcock.org
- Not yet recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Stephanie DeMasi, MD, stephanie.demasi@vumc.org,
- Not yet recruiting
St Barnabas Hospital
New York, New York, 10457
Jonathan Maik, MD, 718-960-9000, jnmaik@gmail.com
- Not yet recruiting
VCU Health
Richmond, Virginia, 23298
Michael Jones, MD, 804-828-9000, Michael.Jones6@vcuhealth.org
- Not yet recruiting
University of Washington
Seattle, Washington, 98104
Adeyinka Adedipe, MD, 206-520-5000, Adeyinka@uw.edu
- Recruiting
UmassMemorial Medical Center
Worcester, Massachusetts, 01655
Romolo Gaspari, MD, 508-334-1400, Romolo.Gaspari@umassmemorial.org
About this study
Official title: Bedside Ultrasound Detection of Occult Prefusion in the Emergency Department Following Out-of-Hospital Cardiac Arrest.
The goal of this study is to describe the population of patients presenting after out of hospital cardiac arrest with occult perfusion, defined as a patient without a palpable pulse but with some evidence of pulsatile arterial flow. The main questions it aims to answer are:
- To measure the prevalence of patients of patients presenting to the emergency department after out of hospital cardiac arrest with occult perfusion
- To measure the association between occult perfusion and survival
- Compare survival between patients with occult perfusion that were treated as pulseless by ACLS interventions vs those treated as hypotensive
Read more
Researchers will describe the percentage of out-of-hospital cardiac arrest presenting to the emergency department without a pulse but with occult perfusion. Researchers will also compare survival endpoints (ROSC, Survival to hospital Admission, and Survival to Hospital Discharge) in pulseless patients with occult perfusion treated with ACLS interventions only and pulseless patients with occult perfusion treated as if they had pulsatile arterial flow.
Participants will undergo resuscitation based on decisions by the clinical team who incorporate echo and/or vascular ultrasound during the first three rounds of CPR. The resuscitation will continue until the patient demonstrates return of spontaneous circulation or until the clinical team halts resuscitative efforts due to futility.
Read the detailed description
This is a multi-center, prospective, observational trial involving sites across the United States and Canada. Patients having suffered an out of hospital cardiac arrest will be enrolled through the emergency department either presenting in cardiac arrest with ongoing CPR or having been resuscitated en-route but re-arresting shortly after arriving in the emergency department.
Patients will undergo any echocardiography or vascular ultrasound during the resuscitation at the discretion of the clinical team and based on institutional protocols. The clinical team will be unblinded to any aspect of the resuscitation, including the echo or vascular ultrasound images. Clinical interventions during the pause in CPR will be classified as ACLS interventions for cardiac arrest or non-ACLS interventions for occult perfusion. ACLS interventions include interventions for cardiac arrest such as bolus epinephrin or CPR. Non-ACLS interventions for occult perfusion include interventions for patients with profound hypotension such as continuous adrenergic agents or halting CPR to check a blood pressure.
Patients will be determined to have demonstrated occult perfusion based on blinded review of the patient data, ultrasound images, and vascular images.
Adjudicated Echo Image Review - Recorded cardiac images blinded to all patient and sonographer information will be reviewed by research staff to identify if a) cardiac activity is present and b) organized cardiac activity is present. Cardiac output will be measured as fractional shortening of the left ventricular chamber. Images will be reviewed separately by expert reviewers blinded to all patient information with adjudication by a third when there is disagreement.
Adjudicated Vascular Image Review - Recorded vascular images blinded to all patient and sonographer information will be reviewed by research staff to identify if arterial pulsations are visible. Measurements on the B-mode imaging will include a) artery diameter (superficial to deep) b) artery diameter (side to side) c) depth of artery from skin surface and d) area of the artery cross section at peak systole and peak diastole. The pulsatile index will be calculated as the ratio of the maximal artery diameter during a single pulsation (superficial to deep) to the minimal artery diameter during a single pulsation(superficial to deep). Images will be reviewed separately by expert reviewers blinded to all patient information with adjudication by a third when there is disagreement.
Patients will be classified as demonstrating occult perfusion with the following findings:
- organized cardiac activity by echo determined to be sufficient to produce an arterial pulse
- pulsatile arterial flow visible on vascular ultrasound determined to be significant
The study has a number of pre-determined study end points that are observational and associative in nature. They include the following:
- Assessment of ECG interpretation accuracy based on comparison of expert review interpretation of ECG and initial clinical interpretation
- Exploratory assessment of number of patients treated as cardiac arrest with bolus EPI and CPR that are determined to be occult perfusion better treated with non-ACLS intervention such as stopping CPR and starting continuous adrenergic agents. The methodology for this is not described in full but will involve a modified Delphi of patient data to determine appropriate categorization.
- Conditions
- Cardiac Arrest, Out-Of-Hospital, Hypotension
- Keywords
- Echocardiography, Vascular Ultrasound, Cardiac Arrest, Out of hospital cardiac arrest, Cardiopulmonary Resuscitation
- Medical subject headings
- Out-of-Hospital Cardiac Arrest, Hypotension, Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Occult Perfusion treated as Cardiac Arrest | Patients presenting after cardiac arrest without a palpable pulse during pauses in CPR but echo or vascular ultrasound findings consistent with pulsatile arterial flow and treated as cardiac arrest with ACLS intervention such as rapid resumption of CPR, bolus epinephrine, or defibrillation. | |
| Occult Perfusion treated as Hypotension | Patients presenting after cardiac arrest without a palpable pulse during pauses in CPR but with echo or vascular ultrasound findings consistent with pulsatile arterial flow AND treated as hypotension with non-ACLS intervention such as continuous adrenergic agents, intravenous fluid, and extend pause in CPR to verify the presence of a measurable blood pressure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival Rate (to Hospital Admission)
The percentage of patients that demonstrate survival that lasts long enough to be admitted to the hospital. Survival is defined as resumption of a sustained, perfusing cardiac activity after cardiac arrest characterized by restoring a palpable pulse, autonomous heart rhythm, and measurable blood pressure lasting long enough to be admitted to the hospital.
Measured: Day 1
Secondary outcomes (2)
Return of Spontaneous Circulation
The percentage of patients that demonstrate a resumption of spontaneous coruscation (ROSC). ROSC is defined as the resumption of a sustained, perfusing cardiac activity after cardiac arrest characterized by restoring a palpable pulse, autonomous heart rhythm, and measurable blood pressure.
Measured: Day 1
Survival to Hospital Discharge
The percentage of patients that demonstrate survival that lasts long enough to be discharged from the hospital.
Measured: Up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study start1 Oct 2026
- Primary completion1 Mar 2029 (estimated)
- Study completion1 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Arrest, Out-Of-HospitalStudies of the same condition, open and under way.
- More trials run by University of Massachusetts, WorcesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Collaborators
- Vanderbilt University School of Medicine, Dartmouth-Hitchcock Medical Center, University of Washington, Truman Medical Center, Icahn School of Medicine at Mount Sinai, MaineHealth, Hennepin Healthcare, University of Florida, University of Tennessee, Chattanooga, University of Kentucky, Maimonides Medical Center, Wake Forest University Health Sciences, University of Arkansas, Christiana Care Health Services, Beth Israel Deaconess Medical Center, Kaweah Delta Health Care District, SBH Health System, Brown University, Prisma Health Richland Hospital, University of Arizona, Boston Medical Center, University of Pittsburgh, Medical College of Wisconsin, State University of New York - Upstate Medical University, Denver Health Medical Center, Case Western Reserve University, Mayo Clinic, Hartford Hospital, advocate christ medical center, Virginia Commonwealth University, Stony Brook University
- Responsible party
- Principal investigator, Romolo Gaspari, University of Massachusetts, Worcester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07897370
- Sponsor's protocol ID
- CPR Pulse Detection - 00001282
- Status last verified
- Oct 2026
- First submitted
- 9 Oct 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Only IPD used in the results publication will be shared
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bedside Ultrasound Detection of Occult Prefusion in the Emergency Department Following Out-of-Hospital Cardiac Arrest.
- ClinicalTrials.gov ID
- NCT07897370
- Acronym / sponsor ID
- CPR Pulse Detection - 00001282
- Conditions
- Cardiac Arrest, Out-Of-Hospital, Hypotension
- Keywords
- Echocardiography, Vascular Ultrasound, Cardiac Arrest, Out of hospital cardiac arrest, Cardiopulmonary Resuscitation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,400 participants (estimated)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Collaborators
- Vanderbilt University School of Medicine, Dartmouth-Hitchcock Medical Center, University of Washington, Truman Medical Center, Icahn School of Medicine at Mount Sinai, MaineHealth, Hennepin Healthcare, University of Florida, University of Tennessee, Chattanooga, University of Kentucky, Maimonides Medical Center, Wake Forest University Health Sciences, University of Arkansas, Christiana Care Health Services, Beth Israel Deaconess Medical Center, Kaweah Delta Health Care District, SBH Health System, Brown University, Prisma Health Richland Hospital, University of Arizona, Boston Medical Center, University of Pittsburgh, Medical College of Wisconsin, State University of New York - Upstate Medical University, Denver Health Medical Center, Case Western Reserve University, Mayo Clinic, Hartford Hospital, advocate christ medical center, Virginia Commonwealth University, Stony Brook University
- Study start
- 1 Oct 2026 (actual)
- Primary completion
- 1 Mar 2029 (estimated)
- Study completion
- 1 Oct 2029 (estimated)
- First posted
- 27 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to describe the population of patients presenting after out of hospital cardiac arrest with occult perfusion, defined as a patient without a palpable pulse but with some evidence of pulsatile arterial flow. The main questions it aims to answer are:
- To measure the prevalence of patients of patients presenting to the emergency department after out of hospital cardiac arrest with occult perfusion
- To measure the association between occult perfusion and survival
- Compare survival between patients with occult perfusion that were treated as pulseless by ACLS interventions vs those treated as hypotensive
Researchers will describe the percentage of out-of-hospital cardiac arrest presenting to the emergency department without a pulse but with occult perfusion. Researchers will also compare survival endpoints (ROSC, Survival to hospital Admission, and Survival to Hospital Discharge) in pulseless patients with occult perfusion treated with ACLS interventions only and pulseless patients with occult perfusion treated as if they had pulsatile arterial flow.
Participants will undergo resuscitation based on decisions by the clinical team who incorporate echo and/or vascular ultrasound during the first three rounds of CPR. The resuscitation will continue until the patient demonstrates return of spontaneous circulation or until the clinical team halts resuscitative efforts due to futility.
Detailed description
This is a multi-center, prospective, observational trial involving sites across the United States and Canada. Patients having suffered an out of hospital cardiac arrest will be enrolled through the emergency department either presenting in cardiac arrest with ongoing CPR or having been resuscitated en-route but re-arresting shortly after arriving in the emergency department.
Patients will undergo any echocardiography or vascular ultrasound during the resuscitation at the discretion of the clinical team and based on institutional protocols. The clinical team will be unblinded to any aspect of the resuscitation, including the echo or vascular ultrasound images. Clinical interventions during the pause in CPR will be classified as ACLS interventions for cardiac arrest or non-ACLS interventions for occult perfusion. ACLS interventions include interventions for cardiac arrest such as bolus epinephrin or CPR. Non-ACLS interventions for occult perfusion include interventions for patients with profound hypotension such as continuous adrenergic agents or halting CPR to check a blood pressure.
Patients will be determined to have demonstrated occult perfusion based on blinded review of the patient data, ultrasound images, and vascular images.
Adjudicated Echo Image Review - Recorded cardiac images blinded to all patient and sonographer information will be reviewed by research staff to identify if a) cardiac activity is present and b) organized cardiac activity is present. Cardiac output will be measured as fractional shortening of the left ventricular chamber. Images will be reviewed separately by expert reviewers blinded to all patient information with adjudication by a third when there is disagreement.
Adjudicated Vascular Image Review - Recorded vascular images blinded to all patient and sonographer information will be reviewed by research staff to identify if arterial pulsations are visible. Measurements on the B-mode imaging will include a) artery diameter (superficial to deep) b) artery diameter (side to side) c) depth of artery from skin surface and d) area of the artery cross section at peak systole and peak diastole. The pulsatile index will be calculated as the ratio of the maximal artery diameter during a single pulsation (superficial to deep) to the minimal artery diameter during a single pulsation(superficial to deep). Images will be reviewed separately by expert reviewers blinded to all patient information with adjudication by a third when there is disagreement.
Patients will be classified as demonstrating occult perfusion with the following findings:
- organized cardiac activity by echo determined to be sufficient to produce an arterial pulse
- pulsatile arterial flow visible on vascular ultrasound determined to be significant
The study has a number of pre-determined study end points that are observational and associative in nature. They include the following:
- Assessment of ECG interpretation accuracy based on comparison of expert review interpretation of ECG and initial clinical interpretation
- Exploratory assessment of number of patients treated as cardiac arrest with bolus EPI and CPR that are determined to be occult perfusion better treated with non-ACLS intervention such as stopping CPR and starting continuous adrenergic agents. The methodology for this is not described in full but will involve a modified Delphi of patient data to determine appropriate categorization.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Occult Perfusion treated as Cardiac Arrest | – | –Patients presenting after cardiac arrest without a palpable pulse during pauses in CPR but echo or vascular ultrasound findings consistent with pulsatile arterial flow and treated as cardiac arrest with ACLS intervention such as rapid resumption of CPR, bolus epinephrine, or defibrillation. |
| Occult Perfusion treated as Hypotension | – | –Patients presenting after cardiac arrest without a palpable pulse during pauses in CPR but with echo or vascular ultrasound findings consistent with pulsatile arterial flow AND treated as hypotension with non-ACLS intervention such as continuous adrenergic agents, intravenous fluid, and extend pause in CPR to verify the presence of a measurable blood pressure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients presenting to the emergency department following atraumatic cardiac arrest with ongoing resuscitation will be considered for enrollment.
Key inclusion criteria (1 listed)
- Patients presenting following out-of-hospital atraumatic cardiac arrest
Key exclusion criteria (5 listed)
- Resuscitation ended due to end-of-life decisions
- Documented allergy to ultrasound gel
- Technical malfunction of ultrasound machine during imaging that prevents use
- Ultrasound machine unable to record images
- Cardiac Ultrasound not performed during first, second or third pause in CPR AND vascular Ultrasound not performed during first, second or third pause in CPR
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Survival Rate (to Hospital Admission)
Time frame: Day 1
The percentage of patients that demonstrate survival that lasts long enough to be admitted to the hospital. Survival is defined as resumption of a sustained, perfusing cardiac activity after cardiac arrest characterized by restoring a palpable pulse, autonomous heart rhythm, and measurable blood pressure lasting long enough to be admitted to the hospital.
2 secondary outcomes
Return of Spontaneous Circulation
Time frame: Day 1
Survival to Hospital Discharge
Time frame: Up to 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: Yes. Only IPD used in the results publication will be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Arrest, Out-Of-Hospital and Hypotension, run by University of Massachusetts, Worcester at 8 sites in United States.
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 5 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: looking for participants now, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival Rate (to Hospital Admission) (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Oct 2026.