Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06637540
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-03
Brief Title:
Clinical Validation of a Novel Handsfree Doppler Ultrasound Device RescueDoppler in Adult Cardiac Surgery Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Clinical Validation of a Novel Ultrasound Probe RescueDoppler During Physiological Perturbations and Initiation Of- and Weaning from Cardiopulmonary Bypass in Adult Cardiac Surgery Patients
Status:
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:
RD_CPB
Brief Summary:
The goal of this study is to evaluate a new device called RescueDoppler RD which measures continuous blood flow in the common carotid artery The device is handsfree and operator- independent The research will involve adult participants who are undergoing cardiac surgery at St Olavs Hospital in Trondheim Norway
The aim of the first part of the study is to evaluate the RescueDoppler system in comparison to conventional Doppler ultrasound which is commonly used to assess blood flow in carotid artery The researchers will measure blood flow in the left common carotid artery in three different reversible situations
when the participant is resting
when there is increased blood flow passive leg raise and
when there is decreased blood flow breathing against a resistance We will initially conduct the investigation using the conventional Doppler Subsequently we will repeat the interventions with the RD patch positioned over the left common carotid artery
The RD patch will stay positioned over the left carotid artery after the completion of the comparison phase In the subsequent phase the focus will shift to transitions between normal blood flow and low or absent blood flow and the RescueDopplers ability to detect During cardiac surgery participants will experience fluctuations in blood pressure pulse and circulation By measuring blood flow with the RescueDoppler during these variations researchers will evaluate the devices capability to monitor different blood flow patterns
Overall the study aims to provide valuable insights into the effectiveness of the RescueDoppler in a clinical setting where changes in blood flow are expected
The aim of the first part of the study is to evaluate the RescueDoppler system in comparison to conventional Doppler ultrasound which is commonly used to assess blood flow in carotid artery The researchers will measure blood flow in the left common carotid artery in three different reversible situations
when the participant is resting
when there is increased blood flow passive leg raise and
when there is decreased blood flow breathing against a resistance We will initially conduct the investigation using the conventional Doppler Subsequently we will repeat the interventions with the RD patch positioned over the left common carotid artery
The RD patch will stay positioned over the left carotid artery after the completion of the comparison phase In the subsequent phase the focus will shift to transitions between normal blood flow and low or absent blood flow and the RescueDopplers ability to detect During cardiac surgery participants will experience fluctuations in blood pressure pulse and circulation By measuring blood flow with the RescueDoppler during these variations researchers will evaluate the devices capability to monitor different blood flow patterns
Overall the study aims to provide valuable insights into the effectiveness of the RescueDoppler in a clinical setting where changes in blood flow are expected
Detailed Description:
During high- risk surgery and critical illness the main goal is to maintain an adequate cardiac output and oxygen delivery to vital organs Accurate hemodynamic monitoring is essential in current critical care medicine and high-risk surgery A systematic review and meta- analysis of non-invasive techniques compared to thermodilution as the reference standard revealed only modest agreement and inadequate percentage error despite advances in medical technology over the last decades This highlights the urgent need for reliable non-invasive method to monitor the perfusion of vulnerable organs during hemodynamically unstable situations
During cardiac arrest CA the quality of cardiopulmonary resuscitation CPR relies on adequate chest-compressions and early shock when indicated As such the recommendations in international and European CPR guidelines consist of several methods to assess the quality of CPR The pulse has been one of the most important diagnostic signs first described in ancient medicine Puls-check is still one of the recommended methods to guide CPR and evaluate possible return of spontaneous circulation ROSC However the pulse-check is imprecise In one study 10 of healthcare workers detected pulse when the patient had cardiac arrest and only 45 were able to palpate pulse when the systolic blood pressure was higher than 80 mmHg In addition pulse check does not predict the magnitude of blood flow In patients with out-of-hospital cardiac arrest OHCA a correlation has been shown between high end tidal carbondioxide EtCO2 values during CPR and ROSC as well as improved long-term survival This method is recommended in international CPR guidelines as a decision-making tool to confirm the correct placement of the endotracheal tube in the trachea serve as a quality indicator of CPR and detect the return of a pulsatile heart rhythm However despite its utility this method has known limitations in identifying ROSC and blood flow and it has limited capacity to differentiate between various causes of cardiac arrest
In cardiac surgery particularly during cardiopulmonary bypass CPB patients experience various manipulations and circulatory changes that increase their vulnerability to complications in multiple organs CPB is an extracorporeal technique that diverts the patients blood away from the heart and lungs rerouting it outside the body This method replaces the normal physiological functions of the lungs and heart by managing oxygenation ventilation and maintaining adequate blood flow through several components of the CPB machine including the pump oxygenator for gas exchange tubing and heat exchange units The CPB pump functions like an artificial heart generating continuous blood flow through a propeller mechanism Blood is collected from the right heart or the vena cava superior andor inferior and is then fully oxygenated before being returned via a cannula into the ascending aorta
At St Olavs Hospital Trondheim University Hospital the routine practice involves cross-clamping the ascending aorta and administering a cardioplegia solution-a cold fluid enriched with electrolytes and medication-to induce cardiac electromechanical silence during procedures These physiological hemodynamic changes are of significant interest to the study group as they involve transitions in blood flow from pulsatile with a fully functioning heart to non-pulsatile due to cross-clamping and cardiac electromechanical silence during the initiation of CPB and back to pulsatile during weaning While cerebral perfusion during CPB has been assessed in previous studies to our knowledge no prior research has specifically investigated cerebral blood flow during the initiation and weaning phases of CPB
Protocols for hemodynamic management during CPB aim for a target flow of 22-28 litersminm² which approximates normal physiological values It is recommended to monitor this flow based on oxygenation and metabolic parameters including central venous oxygenation SvO2 oxygen extraction O2ER Near-Infrared Spectroscopy NIRS venous carbon dioxide VCO2 and lactate levels
Critical illness and intensive care medicine involve a variety of medical conditions making tailored monitoring challenging Many available monitoring tools are invasive require advanced equipment such as PICCO and pulmonary artery catheters or involve time-consuming interventions like passive leg raises which may lead to the omission of hemodynamic guidance in busy clinical settings
Ultrasound has emerged as a vital diagnostic and decision-making tool in critical care particularly echocardiography which can assess cardiac activity and function However it is user-dependent requires specialized knowledge and provides only a snapshot of the clinical situation
The brain is particularly sensitive to hypoxia and during cardiac arrest or surgery hypoperfusion and vasoplegia can impair oxygen delivery affecting treatment outcomes Near-Infrared Spectroscopy NIRS is used to monitor oxygen delivery to the frontal brain during cardiac surgery offering feedback to the treatment team on when to adjust hemodynamic support Research indicates that a 20 decrease in regional hemoglobin oxygen saturation rSO2 increases the risk of neurological complications
Monitoring cerebral blood flow in the middle cerebral artery MCA with Transcranial Doppler TCD provides real-time data on blood flow during surgery A significant reduction in MCA blood flow can signal complications allowing for timely intervention to prevent brain ischemia However TCD requires ultrasound expertise and may present challenges in identifying the insonating window
Carotid Doppler Ultrasound CD is an important method for monitoring blood flow and diagnosing carotid artery stenosis Recently it has been explored as a non-invasive hemodynamic monitoring tool While some studies show promising results the current literature presents mixed findings due to variations in patient populations and study designs Like other ultrasound techniques CD is user-dependent and offers only a snapshot of the situation
In all the clinical situations mentioned a precise non-operator-dependent tool for continuous monitoring to guide and tailor treatment would be highly valuable RescueDoppler is a novel Doppler ultrasound device designed to continuously measure blood flow in the common carotid artery The concept originated from the need for improved methods to guide cardiopulmonary resuscitation CPR and monitor blood flow across various cardiac rhythms
With the increasing body of research supporting carotid Doppler ultrasound as a non-invasive hemodynamic monitoring tool the RescueDoppler technique becomes even more compelling It is user-independent featuring a self-adhesive patch that can be easily positioned using clear anatomical landmarks on the neck While animal studies in cardiac arrest piglets show promising results and unpublished data from a study of RD in in-hopsital and out-of-hospital cardiac arrest show that the RescuDoppler device is feasible More human studies are still needed
The overall aim of the study is to evaluate the RescueDoppler systems performance as a circulatory monitoring tool beyond feasability in patients going through different hemodynamic changes in a safe clinical setting for better patient outcome We will investigate subjects aged 18-80 male and female accepted for cardiac surgery either with coronary artery disease andor valve or aortic disease at St Olavs Hospital Trondheim Norway This is a single-center clinical study We will include 42 patients The enrollment periode will be Q1-Q4 2024 There will be no randomization or blinding in this study
The two phases of the investigation will be conducted sequentially
The primary investigation will compare and by that validate the RescueDoppler device against conventional Doppler ultrasound CD Blood flow velocities in the left common carotid artery will be measured first using CD followed by the RD The primary objective is to evaluate if the RescueDoppler device is noninferior to CD by comparing the flow patterns and velocities recorded with the two methods The primary endpoint is peak systolic velocity secondary outcomes are diastolic velocity time-averaged blood flow velocity TAV among others
During cardiac surgery and CPB the RescueDoppler patch will remain positioned over the left carotid artery We will measure blood flow during key phases such as initiation of CPB aortic cross-clamping and weaning from CPB and compare these measurements with hemodynamic and respiratory variables The primary objective of this part is to evaluate the blood flow signals recorded continuously by the RescueDoppler device by assessing in subjects undergoing circulatory changes from pulsatile- to non-pulsatile blood flow when initiating- and back when weaning from CPB The primary endpoint is time-averaged blood flow velocity TAV
Within the study data about signal quality fastening device functionality data signal management and usefulness of blood flow information will be collected Additionally data will be collected to evaluate the initial clinical safety as per intended use
During cardiac arrest CA the quality of cardiopulmonary resuscitation CPR relies on adequate chest-compressions and early shock when indicated As such the recommendations in international and European CPR guidelines consist of several methods to assess the quality of CPR The pulse has been one of the most important diagnostic signs first described in ancient medicine Puls-check is still one of the recommended methods to guide CPR and evaluate possible return of spontaneous circulation ROSC However the pulse-check is imprecise In one study 10 of healthcare workers detected pulse when the patient had cardiac arrest and only 45 were able to palpate pulse when the systolic blood pressure was higher than 80 mmHg In addition pulse check does not predict the magnitude of blood flow In patients with out-of-hospital cardiac arrest OHCA a correlation has been shown between high end tidal carbondioxide EtCO2 values during CPR and ROSC as well as improved long-term survival This method is recommended in international CPR guidelines as a decision-making tool to confirm the correct placement of the endotracheal tube in the trachea serve as a quality indicator of CPR and detect the return of a pulsatile heart rhythm However despite its utility this method has known limitations in identifying ROSC and blood flow and it has limited capacity to differentiate between various causes of cardiac arrest
In cardiac surgery particularly during cardiopulmonary bypass CPB patients experience various manipulations and circulatory changes that increase their vulnerability to complications in multiple organs CPB is an extracorporeal technique that diverts the patients blood away from the heart and lungs rerouting it outside the body This method replaces the normal physiological functions of the lungs and heart by managing oxygenation ventilation and maintaining adequate blood flow through several components of the CPB machine including the pump oxygenator for gas exchange tubing and heat exchange units The CPB pump functions like an artificial heart generating continuous blood flow through a propeller mechanism Blood is collected from the right heart or the vena cava superior andor inferior and is then fully oxygenated before being returned via a cannula into the ascending aorta
At St Olavs Hospital Trondheim University Hospital the routine practice involves cross-clamping the ascending aorta and administering a cardioplegia solution-a cold fluid enriched with electrolytes and medication-to induce cardiac electromechanical silence during procedures These physiological hemodynamic changes are of significant interest to the study group as they involve transitions in blood flow from pulsatile with a fully functioning heart to non-pulsatile due to cross-clamping and cardiac electromechanical silence during the initiation of CPB and back to pulsatile during weaning While cerebral perfusion during CPB has been assessed in previous studies to our knowledge no prior research has specifically investigated cerebral blood flow during the initiation and weaning phases of CPB
Protocols for hemodynamic management during CPB aim for a target flow of 22-28 litersminm² which approximates normal physiological values It is recommended to monitor this flow based on oxygenation and metabolic parameters including central venous oxygenation SvO2 oxygen extraction O2ER Near-Infrared Spectroscopy NIRS venous carbon dioxide VCO2 and lactate levels
Critical illness and intensive care medicine involve a variety of medical conditions making tailored monitoring challenging Many available monitoring tools are invasive require advanced equipment such as PICCO and pulmonary artery catheters or involve time-consuming interventions like passive leg raises which may lead to the omission of hemodynamic guidance in busy clinical settings
Ultrasound has emerged as a vital diagnostic and decision-making tool in critical care particularly echocardiography which can assess cardiac activity and function However it is user-dependent requires specialized knowledge and provides only a snapshot of the clinical situation
The brain is particularly sensitive to hypoxia and during cardiac arrest or surgery hypoperfusion and vasoplegia can impair oxygen delivery affecting treatment outcomes Near-Infrared Spectroscopy NIRS is used to monitor oxygen delivery to the frontal brain during cardiac surgery offering feedback to the treatment team on when to adjust hemodynamic support Research indicates that a 20 decrease in regional hemoglobin oxygen saturation rSO2 increases the risk of neurological complications
Monitoring cerebral blood flow in the middle cerebral artery MCA with Transcranial Doppler TCD provides real-time data on blood flow during surgery A significant reduction in MCA blood flow can signal complications allowing for timely intervention to prevent brain ischemia However TCD requires ultrasound expertise and may present challenges in identifying the insonating window
Carotid Doppler Ultrasound CD is an important method for monitoring blood flow and diagnosing carotid artery stenosis Recently it has been explored as a non-invasive hemodynamic monitoring tool While some studies show promising results the current literature presents mixed findings due to variations in patient populations and study designs Like other ultrasound techniques CD is user-dependent and offers only a snapshot of the situation
In all the clinical situations mentioned a precise non-operator-dependent tool for continuous monitoring to guide and tailor treatment would be highly valuable RescueDoppler is a novel Doppler ultrasound device designed to continuously measure blood flow in the common carotid artery The concept originated from the need for improved methods to guide cardiopulmonary resuscitation CPR and monitor blood flow across various cardiac rhythms
With the increasing body of research supporting carotid Doppler ultrasound as a non-invasive hemodynamic monitoring tool the RescueDoppler technique becomes even more compelling It is user-independent featuring a self-adhesive patch that can be easily positioned using clear anatomical landmarks on the neck While animal studies in cardiac arrest piglets show promising results and unpublished data from a study of RD in in-hopsital and out-of-hospital cardiac arrest show that the RescuDoppler device is feasible More human studies are still needed
The overall aim of the study is to evaluate the RescueDoppler systems performance as a circulatory monitoring tool beyond feasability in patients going through different hemodynamic changes in a safe clinical setting for better patient outcome We will investigate subjects aged 18-80 male and female accepted for cardiac surgery either with coronary artery disease andor valve or aortic disease at St Olavs Hospital Trondheim Norway This is a single-center clinical study We will include 42 patients The enrollment periode will be Q1-Q4 2024 There will be no randomization or blinding in this study
The two phases of the investigation will be conducted sequentially
The primary investigation will compare and by that validate the RescueDoppler device against conventional Doppler ultrasound CD Blood flow velocities in the left common carotid artery will be measured first using CD followed by the RD The primary objective is to evaluate if the RescueDoppler device is noninferior to CD by comparing the flow patterns and velocities recorded with the two methods The primary endpoint is peak systolic velocity secondary outcomes are diastolic velocity time-averaged blood flow velocity TAV among others
During cardiac surgery and CPB the RescueDoppler patch will remain positioned over the left carotid artery We will measure blood flow during key phases such as initiation of CPB aortic cross-clamping and weaning from CPB and compare these measurements with hemodynamic and respiratory variables The primary objective of this part is to evaluate the blood flow signals recorded continuously by the RescueDoppler device by assessing in subjects undergoing circulatory changes from pulsatile- to non-pulsatile blood flow when initiating- and back when weaning from CPB The primary endpoint is time-averaged blood flow velocity TAV
Within the study data about signal quality fastening device functionality data signal management and usefulness of blood flow information will be collected Additionally data will be collected to evaluate the initial clinical safety as per intended use
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