Cardiac Arrest (CA)NCT07729228
Pulse Detection in Cardiac Arrest Patients Using a Doppler Ultrasound Patch on the Carotid Artery
An observational study of Cardiac Arrest (CA) and Return of Spontaneous Circulation, run by Heartstream US LLC at 1 site in United States.
Trial summary
The purpose of this study is to find out if a Doppler ultrasound patch placed on the neck can accurately and quickly detect when a cardiac arrest patient's heart starts beating again (return of spontaneous circulation, or ROSC) during resuscitation in the emergency department. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Cardiac Arrest (CA), Return of Spontaneous Circulation, CPR Quality Assessment
- What is being tested?
- Ultrasound doppler perfusion monitoring
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2026to 15 Aug 2027
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Any patient that comes into the University Hospital's Emergency Department displaying signs and symptoms of cardiac arrest may be considered for this effort. Only those patients that receive an arterial line as part of standard of care will be enrolled into the effort.
Who may be able to join
- Any adult patient aged > 18 to 99 years old
- Intact skin on their neck
- In cardiac arrest with an arterial line placed during the resuscitation event as part of the standard of care.
Who cannot join
- Patients in cardiac arrest with a Do Not Resuscitate/Do Not Intubate (DNR/DNI) order.
- Patients without an arterial line in place as part of the standard of care.
- *Pregnant women
- *Prisoners
- Any data from these two populations (pregnant/prisoner) will not be downloaded at all if it is discovered post-resuscitation event that the patient is pregnant and/or a prisoner.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Northwell Health
Manhasset, New York, 11030
Elizabeth Young, 516-562-1255, eyoung8@northwell.edu
Daniel Rolston, MD
About this study
The purpose of this study is to find out if a Doppler ultrasound patch placed on the neck can accurately and quickly detect when a cardiac arrest patient's heart starts beating again (return of spontaneous circulation, or ROSC) during resuscitation in the emergency department. The study compares the ultrasound readings to data from an arterial line, which is considered the most reliable way to check for a pulse. The main question the study is trying to answer is whether using Doppler ultrasound is better than the traditional method of feeling for a pulse, which can be unreliable, especially in stressful situations. Secondarily, this study aims to assess blood flow through the carotid artery from chest compressions during resuscitative events to determine overall effectiveness. This research hopes to show that Doppler ultrasound can help medical teams recognize when a patient's heart has restarted more accurately and quickly, leading to better care during cardiac arrest.
- Being tested
- Ultrasound doppler perfusion monitoring
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound doppler perfusion monitoringDevice
A Doppler ultrasound patch will be placed on the patient's neck over the carotid artery to continuously record blood flow during resuscitation. For patients who already have an arterial line as part of their regular care, whether a pulse is present or not will also be recorded at each pulse check. No arterial lines will be inserted just for this study. There is no change to patient care.
| Study group | Role | What they receive |
|---|---|---|
| Code Advanced Cardiac Life Support | Patients will be considered for inclusion if they are in cardiac arrest with an arterial line. Receives: Device: Ultrasound doppler perfusion monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of Doppler Ultrasound Patch for Detecting Return of Spontaneous Circulation During Cardiac Arrest
Evaluate how well the Doppler ultrasound patch can detect when a cardiac arrest patient's heart starts adequately beating again, by comparing its results to blood pressure readings from an arterial line.
Measured: Periprocedural
Secondary outcomes (1)
Association Between Doppler Ultrasound Patch Waveforms and Chest Compression Quality During Cardiac Arrest
Determine if the Doppler ultrasound patch readings on the neck during chest compressions match up with measures of chest compression quality, using data from the cardiac monitors.
Measured: Periprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2026
- Study start15 Aug 2026 (estimated)
- Primary completion15 Aug 2027 (estimated)
- Study completion15 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (30)Papers the sponsor has linked to this study.
- Other trials for Cardiac Arrest (CA)Studies of the same condition, open and under way.
- 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heartstream US LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Northwell Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07729228
- Sponsor's protocol ID
- 2022-00415
- Status last verified
- Jul 2026
- First submitted
- 20 Jul 2026
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: To be determined
Publications
NYSORA - Education, "DIFFICULT IV: ULTRASOUND GUIDED BRACHIAL VEIN," YouTube, Jun. 22, 2022. [Online]. Available: https://www.youtube.com/watch?v=mxxRqKONfVI. Accessed: Dec. 9, 2025.
Fatahi Asl J, Farzanegan Z, Tahmasbi M, Birgani SM, Malekzade M, Yazdaninejad H. Evaluation of the Scan Duration and Mechanical and Thermal Indices Applied for the Diagnostic Ultrasound Examinations. J Ultrasound Med. 2021 Sep;40(9):1839-1850. doi: 10.1002/jum.15565. Epub 2020 Nov 12.
PubMed 33179801American Institute of Ultrasound in Medicine, "Recommended Maximum Scanning Times for Displayed Thermal Index (TI) Values," Sep. 26, 2022. [Online]. Available: https://www.aium.org/resources/official-statements/view/recommended-maximum-scanning-times-for-displayed-thermal-index-%28ti%29-values (accessed Dec. 9, 2025)
U.S. Food and Drug Administration, Center for Devices and Radiological Health, "Marketing Clearance of Diagnostic Ultrasound Systems and Transducers: Guidance for Industry and Food and Drug Administration Staff," Feb. 21, 2023. [Online]. Available: https://www.fda.gov/media/71100/download
Faldaas BO, Storm BS, Lappegard KT, How OJ, Nilsen BA, Kiss G, Skogvoll E, Nielsen EW, Torp H, Ingul CB. A hands-free carotid Doppler can identify spontaneous circulation without interrupting cardiopulmonary resuscitation: an animal study. Intensive Care Med Exp. 2024 Dec 27;12(1):121. doi: 10.1186/s40635-024-00704-w.
PubMed 39730782Faldaas BO, Nielsen EW, Storm BS, Lappegard KT, Nilsen BA, Kiss G, Skogvoll E, Torp H, Ingul CB. Real-time feedback on chest compression efficacy by hands-free carotid Doppler in a porcine model. Resusc Plus. 2024 Feb 20;18:100583. doi: 10.1016/j.resplu.2024.100583. eCollection 2024 Jun.
PubMed 38404755Faldaas BO, Nielsen EW, Storm BS, Lappegard KT, How OJ, Nilsen BA, Kiss G, Skogvoll E, Torp H, Ingul C. Hands-free continuous carotid Doppler ultrasound for detection of the pulse during cardiac arrest in a porcine model. Resusc Plus. 2023 Jun 20;15:100412. doi: 10.1016/j.resplu.2023.100412. eCollection 2023 Sep.
PubMed 37448689Cimon Medical, RescueDoppler, Investigator's Brochure, edition version 3.3, 2025-03-18. Trondheim, Norway.
Badra K, Coutin A, Simard R, Pinto R, Lee JS, Chenkin J. The POCUS pulse check: A randomized controlled crossover study comparing pulse detection by palpation versus by point-of-care ultrasound. Resuscitation. 2019 Jun;139:17-23. doi: 10.1016/j.resuscitation.2019.03.009. Epub 2019 Mar 20.
PubMed 30902687Clark LR, McDannold R, Mullins M, Bobrow B. Abstract 458: Pause duration during manual CPR is associated with survival and favorable neurological outcome in all-rhythm OHCA. Circulation 2019;140. https://doi.org/10.1161/circ.140.suppl_2.458. A458-A458.
Nolan JP, Maconochie I, Soar J, Olasveengen TM, Greif R, Wyckoff MH, Singletary EM, Aickin R, Berg KM, Mancini ME, Bhanji F, Wyllie J, Zideman D, Neumar RW, Perkins GD, Castren M, Morley PT, Montgomery WH, Nadkarni VM, Billi JE, Merchant RM, de Caen A, Escalante-Kanashiro R, Kloeck D, Wang TL, Hazinski MF. Executive Summary 2020 International Consensus on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science With Treatment Recommendations. Resuscitation. 2020 Nov;156:A1-A22. doi: 10.1016/j.resuscitation.2020.09.009. Epub 2020 Oct 21. No abstract available.
PubMed 33098915Panchal 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 33081529Kang SY, Jo IJ, Lee G, Park JE, Kim T, Lee SU, Hwang SY, Shin TG, Kim K, Shim JS, Yoon H. Point-of-care ultrasound compression of the carotid artery for pulse determination in cardiopulmonary resuscitation. Resuscitation. 2022 Oct;179:206-213. doi: 10.1016/j.resuscitation.2022.06.025. Epub 2022 Jul 2.
PubMed 35792305Sanchez S, Miller M, Asha S. Assessing the validity of two-dimensional carotid ultrasound to detect the presence and absence of a pulse. Resuscitation. 2020 Dec;157:67-73. doi: 10.1016/j.resuscitation.2020.10.002. Epub 2020 Oct 12.
PubMed 33058995Rolston DM, Nello AV, Li T, Jafari J, Becker LB, Owens C, Haddad-Essaihi G, Cohen AL. Abstract 199: Femoral artery Doppler ultrasound blood flow patterns predict intrinsic pulsatility in cardiac arrest patients receiving active chest compressions. Circulation. 2022 Oct;146(Suppl_1):A199-A199. https://doi.org/10.1161/circ.146.suppl_1.199.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulse Detection in Cardiac Arrest Patients Using a Doppler Ultrasound Patch on the Carotid Artery
- ClinicalTrials.gov ID
- NCT07729228
- Acronym / sponsor ID
- 2022-00415
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Heartstream US LLCIndustry (pharma, biotech, devices)
- Collaborators
- Northwell Health
- Study start
- 15 Aug 2026 (estimated)
- Primary completion
- 15 Aug 2027 (estimated)
- Study completion
- 15 Aug 2027 (estimated)
- First posted
- 27 Jul 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 purpose of this study is to find out if a Doppler ultrasound patch placed on the neck can accurately and quickly detect when a cardiac arrest patient's heart starts beating again (return of spontaneous circulation, or ROSC) during resuscitation in the emergency department. The study compares the ultrasound readings to data from an arterial line, which is considered the most reliable way to check for a pulse. The main question the study is trying to answer is whether using Doppler ultrasound is better than the traditional method of feeling for a pulse, which can be unreliable, especially in stressful situations. Secondarily, this study aims to assess blood flow through the carotid artery from chest compressions during resuscitative events to determine overall effectiveness. This research hopes to show that Doppler ultrasound can help medical teams recognize when a patient's heart has restarted more accurately and quickly, leading to better care during cardiac arrest.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Code Advanced Cardiac Life Support | – | Device: Ultrasound doppler perfusion monitoringPatients will be considered for inclusion if they are in cardiac arrest with an arterial line. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any patient that comes into the University Hospital's Emergency Department displaying signs and symptoms of cardiac arrest may be considered for this effort. Only those patients that receive an arterial line as part of standard of care will be enrolled into the effort.
Key inclusion criteria (3 listed)
- Any adult patient aged > 18 to 99 years old
- Intact skin on their neck
- In cardiac arrest with an arterial line placed during the resuscitation event as part of the standard of care.
Key exclusion criteria (5 listed)
- Patients in cardiac arrest with a Do Not Resuscitate/Do Not Intubate (DNR/DNI) order.
- Patients without an arterial line in place as part of the standard of care.
- *Pregnant women
- *Prisoners
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound doppler perfusion monitoringA Doppler ultrasound patch will be placed on the patient's neck over the carotid artery to continuously record blood flow during resuscitation. For patients who already have an arterial line as part of their regular care, whether a pulse is present or not will also be recorded at each pulse check. No arterial lines will be inserted just for this study. There is no change to patient care. | Device | Code Advanced Cardiac Life Support |
Primary outcome
Accuracy of Doppler Ultrasound Patch for Detecting Return of Spontaneous Circulation During Cardiac Arrest
Time frame: Periprocedural
Evaluate how well the Doppler ultrasound patch can detect when a cardiac arrest patient's heart starts adequately beating again, by comparing its results to blood pressure readings from an arterial line.
1 secondary outcome
Association Between Doppler Ultrasound Patch Waveforms and Chest Compression Quality During Cardiac Arrest
Time frame: Periprocedural
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 Jul 2026.
- BackgroundNYSORA - Education, "DIFFICULT IV: ULTRASOUND GUIDED BRACHIAL VEIN," YouTube, Jun. 22, 2022. [Online]. Available: https://www.youtube.com/watch?v=mxxRqKONfVI. Accessed: Dec. 9, 2025.
- Background: PubMed 33179801Fatahi Asl J, Farzanegan Z, Tahmasbi M, Birgani SM, Malekzade M, Yazdaninejad H. Evaluation of the Scan Duration and Mechanical and Thermal Indices Applied for the Diagnostic Ultrasound Examinations. J Ultrasound Med. 2021 Sep;40(9):1839-1850. doi: 10.1002/jum.15565. Epub 2020 Nov 12.
- BackgroundAmerican Institute of Ultrasound in Medicine, "Recommended Maximum Scanning Times for Displayed Thermal Index (TI) Values," Sep. 26, 2022. [Online]. Available: https://www.aium.org/resources/official-statements/view/recommended-maximum-scanning-times-for-displayed-thermal-index-%28ti%29-values (accessed Dec. 9, 2025)
- BackgroundU.S. Food and Drug Administration, Center for Devices and Radiological Health, "Marketing Clearance of Diagnostic Ultrasound Systems and Transducers: Guidance for Industry and Food and Drug Administration Staff," Feb. 21, 2023. [Online]. Available: https://www.fda.gov/media/71100/download
- Background: PubMed 39730782Faldaas BO, Storm BS, Lappegard KT, How OJ, Nilsen BA, Kiss G, Skogvoll E, Nielsen EW, Torp H, Ingul CB. A hands-free carotid Doppler can identify spontaneous circulation without interrupting cardiopulmonary resuscitation: an animal study. Intensive Care Med Exp. 2024 Dec 27;12(1):121. doi: 10.1186/s40635-024-00704-w.
- Background: PubMed 38404755Faldaas BO, Nielsen EW, Storm BS, Lappegard KT, Nilsen BA, Kiss G, Skogvoll E, Torp H, Ingul CB. Real-time feedback on chest compression efficacy by hands-free carotid Doppler in a porcine model. Resusc Plus. 2024 Feb 20;18:100583. doi: 10.1016/j.resplu.2024.100583. eCollection 2024 Jun.
- Background: PubMed 37448689Faldaas BO, Nielsen EW, Storm BS, Lappegard KT, How OJ, Nilsen BA, Kiss G, Skogvoll E, Torp H, Ingul C. Hands-free continuous carotid Doppler ultrasound for detection of the pulse during cardiac arrest in a porcine model. Resusc Plus. 2023 Jun 20;15:100412. doi: 10.1016/j.resplu.2023.100412. eCollection 2023 Sep.
- BackgroundCimon Medical, RescueDoppler, Investigator's Brochure, edition version 3.3, 2025-03-18. Trondheim, Norway.
- Background: PubMed 30902687Badra K, Coutin A, Simard R, Pinto R, Lee JS, Chenkin J. The POCUS pulse check: A randomized controlled crossover study comparing pulse detection by palpation versus by point-of-care ultrasound. Resuscitation. 2019 Jun;139:17-23. doi: 10.1016/j.resuscitation.2019.03.009. Epub 2019 Mar 20.
- BackgroundClark LR, McDannold R, Mullins M, Bobrow B. Abstract 458: Pause duration during manual CPR is associated with survival and favorable neurological outcome in all-rhythm OHCA. Circulation 2019;140. https://doi.org/10.1161/circ.140.suppl_2.458. A458-A458.
- Background: PubMed 33098915Nolan JP, Maconochie I, Soar J, Olasveengen TM, Greif R, Wyckoff MH, Singletary EM, Aickin R, Berg KM, Mancini ME, Bhanji F, Wyllie J, Zideman D, Neumar RW, Perkins GD, Castren M, Morley PT, Montgomery WH, Nadkarni VM, Billi JE, Merchant RM, de Caen A, Escalante-Kanashiro R, Kloeck D, Wang TL, Hazinski MF. Executive Summary 2020 International Consensus on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science With Treatment Recommendations. Resuscitation. 2020 Nov;156:A1-A22. doi: 10.1016/j.resuscitation.2020.09.009. Epub 2020 Oct 21. No abstract available.
- Background: PubMed 33081529Panchal 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.
- Individual participant dataSharing planned: Undecided. To be determined
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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.
1 site 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 (CA) and Return of Spontaneous Circulation, run by Heartstream US LLC at 1 site 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 3 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: opening soon, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Contact Will Sabol (412-860-0775, will.sabol@philips.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of Doppler Ultrasound Patch for Detecting Return of Spontaneous Circulation During Cardiac Arrest (time frame: Periprocedural). 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 NCT07729228, which also lists 30 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 27 Jul 2026.