Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06599073
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-05
Brief Title:
RescueDoppler- a Disruptive Ultrasound Solution for Improved Outcome After Cardiac Arrest
Sponsor:
None
Organization:
None
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RescueDoppler
Brief 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 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
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 It39s 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 hearts normal electrical activity and ensuring adequate blood flow to vital organs Currently only the hearts 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 dont 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 wont 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
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 hearts normal electrical activity and ensuring adequate blood flow to vital organs Currently only the hearts 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 dont 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 wont 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None