Cardiac Arrest (CA)RescueDopplerNCT06599073
RescueDoppler- a Disruptive Ultrasound Solution for Improved Outcome After Cardiac Arrest.
A study testing RescueDoppler and Rescue in people with Cardiac Arrest (CA) and Cardiopulmonary Resuscitation, run by Norwegian University of Science and Technology at 8 sites in 2 countries.
Trial summary
RescueDoppler is an innovative, hands-free Doppler system designed for continuous monitoring of blood flow in the carotid artery, distinguishing between the presence and absence of a pulse. It is non-invasive, user-independent, and does not require specialized ultrasound expertise. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrest (CA), Cardiopulmonary Resuscitation, Doppler Ultrasound
- What is being tested?
- RescueDoppler and Rescue
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 285 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 19 Sep 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Male or female, aged 18 years or older. Subjects experiencing a sudden cardiac arrest, either pre-hospital or in-hospital. Sudden cardiac arrest is defined as the abrupt loss of heart function, breathing, and consciousness.
Who cannot join
- Subjects where resuscitation is not continued after the initial application of RescueDoppler or resuscitation efforts are halted due to a do-not-resuscitate order.
- Subjects deemed unable to comply with the study requirements as determined by the Investigator.
- Subjects with extensive trauma injuries that prevent proper attachment of the RescueDoppler patch.
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
Norway7 sites
Haukeland University Hospital, Surgical Services Clinic, Department of Emergency Medicine
Bergen, Vestland, 5201
Nordland Hospital
Bodø
Akershus university hospital
Loerenskog, Akershus, 1478
Oslo University Hospital Ullevål location Lørenskog
Oslo, 1474
Oslo University Hospital Rikshospitalet
Oslo
Oslo University Hospital Ullevaal
Oslo
St Olavs University Hospital
Trondheim, 7491
About this study
Official title: A Feasibility Study to Evaluate a New Doppler Method (RescueDoppler) for Monitoring Blood Flow in the Carotid Artery in Subjects Suffering From Sudden Cardiac Arrest
RescueDoppler is an innovative, hands-free Doppler system designed for continuous monitoring of blood flow in the carotid artery, distinguishing between the presence and absence of a pulse. It is non-invasive, user-independent, and does not require specialized ultrasound expertise. The primary goal of this study is to assess the feasibility and clinical utility of RescueDoppler for monitoring carotid artery blood flow in patients experiencing sudden cardiac arrest.
The multi-center study will be performed both pre-hospital and in-hospital.
Read the detailed description
When treating sudden cardiac arrest (SCA), manual pulse checks are currently the standard method to detect blood flow, but this approach has significant limitations. It\'s neither quick nor consistently reliable (Germanoska et al. 2018, Eberle et al. 1996). Studies show that 45% of healthcare workers struggle to accurately detect a central pulse during cardiac arrest (Moule 2000, Nakagawa et al. 2010). If blood flow has already been restored, continuing chest compressions could cause more harm than good. This highlights the need for an easy-to-use tool to assess blood flow during cardiopulmonary resuscitation (CPR).
Cardiac arrest is responsible for 7-8 million deaths per year and ranks as the third leading cause of death in industrialized countries. Despite advances in resuscitation techniques and post-resuscitation care, the survival rate following cardiac arrest remains low-around 10% or less. Survival rates drop sharply with every minute that passes without advanced cardiac life support (OECD 2017). Successful resuscitation after cardiac arrest requires restoring the heart's normal electrical activity and ensuring adequate blood flow to vital organs. Currently, only the heart's electrical activity (via electrocardiogram [ECG]) is monitored during resuscitation, with no information available on blood flow.
CPR involves chest compressions and artificial ventilation to maintain circulation and oxygenation. In cases of shockable rhythms, a defibrillator delivers an electrical shock to the heart. Automated external defibrillators (AEDs) are capable of diagnosing life-threatening arrhythmias, enabling even untrained bystanders to use them effectively. However, while defibrillators can detect, treat, and confirm the return of normal heart rhythm, they don't provide feedback on whether blood flow has been successfully restored (return of spontaneous circulation [ROSC]). A quicker ROSC is linked to better long-term survival outcomes.
Non-shockable rhythms, such as pulseless electrical activity (PEA) and asystole, are increasingly common. Research shows that up to 60% of patients with suspected PEA and 10-35% of those with suspected asystole still have mechanical heart activity (Deakin 2000, Gaspari et al. 2016). In these cases, using cardiac ultrasound has changed patient management in 78% of cases and has been linked to increased survival. European Resuscitation Council guidelines recommend limiting interruptions during CPR to 10 seconds to check for a pulse (Perkins et al. 2021). However, cardiac ultrasound cannot be performed during chest compressions, which limits its usefulness (Zengin et al. 2018).
Doppler ultrasound measurements of carotid artery blood flow offer a promising alternative for guiding CPR without interrupting resuscitation. The RescueDoppler system, a newly developed ultrasound Doppler tool, continuously monitors blood flow in the carotid artery during CPR.
The RescueDoppler device uses a small ultrasound probe that is quickly attached over the carotid artery using an innovative patch. This probe continuously monitors blood flow to the brain, alerting first responders if chest compressions are ineffective or if the patient has achieved ROSC (when the heart starts beating again).
RescueDoppler probe is placed on the left side of the neck during cardiac arrest to monitor blood flow from the carotid artery during CPR. The medical team won't see the signals during this phase.
The multi-centre study will involve 300 patients experiencing in-hospital or pre-hospital cardiac arrests. Five hospitals in Norway will participate in the in-hospital portion, with recruitment expected to take one year. The pre-hospital study will include two hospitals in Norway, also with a one-year recruitment period. The goal is to gather crucial medical and physiological data on blood circulation during cardiac arrest, beyond initial feasibility.
- Being tested
- RescueDoppler, Rescue
- Keywords
- Continuous ultrasound during cardiac arrest
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RescueDopplerDevice
Also called Carotid Doppler
Continuous hands-free Doppler ultrasound of the carotid artery during cardiac arrest
RescueDevice
RescueDoppler patch with probe is attached on the left side of the neck during the cardiac arrest. Operative health personell are blinded for the velocity curves that are post-processed by the research team after the cardiac arrest and synchronised with ECG.
| Study group | Role | What they receive |
|---|---|---|
| RescueDoppler patch with probe is attached to patients with cardiac arrest | Experimental | The RescueDoppler probe and patch are placed on the left side of the patient's neck in both pre-hospital and in-hospital settings. The RescueDoppler system is blinded to the medical personnel during the cardiac arrest and is not used for real-time monitoring. After the cardiac arrest, the velocity curves are processed by the research team and synchronized with the ECG for analysis. Receives: Device: RescueDoppler; Device: Rescue |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with carotid peak blood flow velocity of more than 20 cm/second during cardiopulmonary resuscitation
A carotid peak blood flow velocity of zero indicates the absence of spontaneous circulation during cardiopulmonary resuscitation, while velocities exceeding 20 cm/second suggest the presence of spontaneous circulation.
Measured: From enrollment to the end after 12 months
Secondary outcomes (1)
Number of patients with carotid peak blood flow velocity of more than 50 cm/second during chest compressions
A carotid peak blood flow velocity of zero indicates ineffective chest compressions, while velocities exceeding 50 cm/second suggest that the chest compressions are effective.
Measured: From enrollment to the end after 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start19 Sep 2024
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiac Arrest (CA)Studies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 285 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- St. Olavs Hospital, Nordlandssykehuset HF, Ullevaal University Hospital, Rikshospitalet University Hospital, University Hospital, Akershus, Haukeland University Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06599073
- Sponsor's protocol ID
- 582681
- Other IDs
- 332205
- Acronym
- RescueDoppler
- Status last verified
- Feb 2026
- First submitted
- 5 Sep 2024
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: ECG and carotid blood flow velocity will be shared if required.
Publications
Faldaas 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 37448689
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study to Evaluate a New Doppler Method (RescueDoppler) for Monitoring Blood Flow in the Carotid Artery in Subjects Suffering From Sudden Cardiac Arrest
- ClinicalTrials.gov ID
- NCT06599073
- Acronym / sponsor ID
- RescueDoppler / 582681
- Keywords
- Continuous ultrasound during cardiac arrest
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 285 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- St. Olavs Hospital, Nordlandssykehuset HF, Ullevaal University Hospital, Rikshospitalet University Hospital, University Hospital, Akershus, Haukeland University Hospital
- Study start
- 19 Sep 2024 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 19 Sep 2024 (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.
RescueDoppler is an innovative, hands-free Doppler system designed for continuous monitoring of blood flow in the carotid artery, distinguishing between the presence and absence of a pulse. It is non-invasive, user-independent, and does not require specialized ultrasound expertise. The primary goal of this study is to assess the feasibility and clinical utility of RescueDoppler for monitoring carotid artery blood flow in patients experiencing sudden cardiac arrest.
The multi-center study will be performed both pre-hospital and in-hospital.
Detailed description
When treating sudden cardiac arrest (SCA), manual pulse checks are currently the standard method to detect blood flow, but this approach has significant limitations. It\'s neither quick nor consistently reliable (Germanoska et al. 2018, Eberle et al. 1996). Studies show that 45% of healthcare workers struggle to accurately detect a central pulse during cardiac arrest (Moule 2000, Nakagawa et al. 2010). If blood flow has already been restored, continuing chest compressions could cause more harm than good. This highlights the need for an easy-to-use tool to assess blood flow during cardiopulmonary resuscitation (CPR).
Cardiac arrest is responsible for 7-8 million deaths per year and ranks as the third leading cause of death in industrialized countries. Despite advances in resuscitation techniques and post-resuscitation care, the survival rate following cardiac arrest remains low-around 10% or less. Survival rates drop sharply with every minute that passes without advanced cardiac life support (OECD 2017). Successful resuscitation after cardiac arrest requires restoring the heart's normal electrical activity and ensuring adequate blood flow to vital organs. Currently, only the heart's electrical activity (via electrocardiogram [ECG]) is monitored during resuscitation, with no information available on blood flow.
CPR involves chest compressions and artificial ventilation to maintain circulation and oxygenation. In cases of shockable rhythms, a defibrillator delivers an electrical shock to the heart. Automated external defibrillators (AEDs) are capable of diagnosing life-threatening arrhythmias, enabling even untrained bystanders to use them effectively. However, while defibrillators can detect, treat, and confirm the return of normal heart rhythm, they don't provide feedback on whether blood flow has been successfully restored (return of spontaneous circulation [ROSC]). A quicker ROSC is linked to better long-term survival outcomes.
Non-shockable rhythms, such as pulseless electrical activity (PEA) and asystole, are increasingly common. Research shows that up to 60% of patients with suspected PEA and 10-35% of those with suspected asystole still have mechanical heart activity (Deakin 2000, Gaspari et al. 2016). In these cases, using cardiac ultrasound has changed patient management in 78% of cases and has been linked to increased survival. European Resuscitation Council guidelines recommend limiting interruptions during CPR to 10 seconds to check for a pulse (Perkins et al. 2021). However, cardiac ultrasound cannot be performed during chest compressions, which limits its usefulness (Zengin et al. 2018).
Doppler ultrasound measurements of carotid artery blood flow offer a promising alternative for guiding CPR without interrupting resuscitation. The RescueDoppler system, a newly developed ultrasound Doppler tool, continuously monitors blood flow in the carotid artery during CPR.
The RescueDoppler device uses a small ultrasound probe that is quickly attached over the carotid artery using an innovative patch. This probe continuously monitors blood flow to the brain, alerting first responders if chest compressions are ineffective or if the patient has achieved ROSC (when the heart starts beating again).
RescueDoppler probe is placed on the left side of the neck during cardiac arrest to monitor blood flow from the carotid artery during CPR. The medical team won't see the signals during this phase.
The multi-centre study will involve 300 patients experiencing in-hospital or pre-hospital cardiac arrests. Five hospitals in Norway will participate in the in-hospital portion, with recruitment expected to take one year. The pre-hospital study will include two hospitals in Norway, also with a one-year recruitment period. The goal is to gather crucial medical and physiological data on blood circulation during cardiac arrest, beyond initial feasibility.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RescueDoppler patch with probe is attached to patients with cardiac arrest | Experimental | Device: RescueDoppler, Device: RescueThe RescueDoppler probe and patch are placed on the left side of the patient's neck in both pre-hospital and in-hospital settings. The RescueDoppler system is blinded to the medical personnel during the cardiac arrest and is not used for real-time monitoring. After the cardiac arrest, the velocity curves are processed by the research team and synchronized with the ECG for analysis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Male or female, aged 18 years or older. Subjects experiencing a sudden cardiac arrest, either pre-hospital or in-hospital. Sudden cardiac arrest is defined as the abrupt loss of heart function, breathing, and consciousness.
Key exclusion criteria (3 listed)
- Subjects where resuscitation is not continued after the initial application of RescueDoppler or resuscitation efforts are halted due to a do-not-resuscitate order.
- Subjects deemed unable to comply with the study requirements as determined by the Investigator.
- Subjects with extensive trauma injuries that prevent proper attachment of the RescueDoppler patch.
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 |
|---|---|---|
| RescueDopplerAlso: Carotid DopplerContinuous hands-free Doppler ultrasound of the carotid artery during cardiac arrest | Device | RescueDoppler patch with probe is attached to patients with cardiac arrest |
| RescueRescueDoppler patch with probe is attached on the left side of the neck during the cardiac arrest. Operative health personell are blinded for the velocity curves that are post-processed by the research team after the cardiac arrest and synchronised with ECG. | Device | RescueDoppler patch with probe is attached to patients with cardiac arrest |
Primary outcome
Number of patients with carotid peak blood flow velocity of more than 20 cm/second during cardiopulmonary resuscitation
Time frame: From enrollment to the end after 12 months
A carotid peak blood flow velocity of zero indicates the absence of spontaneous circulation during cardiopulmonary resuscitation, while velocities exceeding 20 cm/second suggest the presence of spontaneous circulation.
1 secondary outcome
Number of patients with carotid peak blood flow velocity of more than 50 cm/second during chest compressions
Time frame: From enrollment to the end after 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Results publication: 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.
- Results publication: 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.
- RescueDoppler websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. ECG and carotid blood flow velocity will be shared if required.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RescueDoppler and Rescue in people with Cardiac Arrest (CA) and Cardiopulmonary Resuscitation, run by Norwegian University of Science and Technology at 8 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: finished, as of the sponsor's last update on 27 Feb 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 Norway, Sweden. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with carotid peak blood flow velocity of more than 20 cm/second during cardiopulmonary resuscitation (time frame: From enrollment to the end after 12 months). 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 NCT06599073, which also lists 2 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 Feb 2026.