Clinical Validation of a Novel Handsfree Doppler Ultrasound Device, RescueDoppler, in Adult Cardiac Surgery Patients

NCT ID: NCT06637540

Last Updated: 2024-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-28

Study Completion Date

2024-11-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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 device´s 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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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 patient's 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 and/or 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 2.2-2.8 liters/min/m², 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 system's 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 and/or valve or aortic disease at St. Olav´s 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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cardio-pulmonary Bypass AORTIC VALVE DISEASES Coronary Arterial Disease (CAD) Aortic Aneurysm of the Proximal Arch

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

RescueDoppler patch with probe is attached to patients undergoing cardiac surgery.

The RescueDoppler probe and patch are placed on the left side of the patient's neck in both preoperative and during surgery settings. The RescueDoppler system is connected to a screen with real-time bloodflow monitoring. The the blood flow curves are blinded for other health personell. After the cardiac surgery, the velocity curves are processed by the research team and synchronized with hemodynamic and respiratory data for analysis.

Group Type EXPERIMENTAL

RescueDoppler

Intervention Type DEVICE

Continous handsfree pulsed wave Doppler of the common carotid artery during cardiac surgery

RescueDoppler

Intervention Type DEVICE

Continuous hands-free Doppler ultrasound of the common carotid artery during cardiac surgery

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

RescueDoppler

Continous handsfree pulsed wave Doppler of the common carotid artery during cardiac surgery

Intervention Type DEVICE

RescueDoppler

Continuous hands-free Doppler ultrasound of the common carotid artery during cardiac surgery

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

RD Carotid Pulsed waved Doppler Carotid Doppler Continous Carotid Doppler Rescue

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Accepted for cardiac-, valve- and aortic surgery
2. Circulatory stable
3. Male and female
4. any BMI
5. Age 18-80

Exclusion Criteria

1. Significant left carotid artery stenosis (\> 50%)
2. Carotid stent or has had surgery to the left carotid artery
3. Emergency surgery
4. Hemodynamic unstable
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

St. Olavs Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

St. Oalvs Hospital, Trondheim University Hospital

Trondheim, , Norway

Site Status

St.Olavs Hospital, Trondheim University Hospital

Trondheim, , Norway

Site Status

St. Olavs Hospital, Trondheim University Hospital

Trondheim, , Norway

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Norway

References

Explore related publications, articles, or registry entries linked to this study.

Moritz S, Kasprzak P, Arlt M, Taeger K, Metz C. Accuracy of cerebral monitoring in detecting cerebral ischemia during carotid endarterectomy: a comparison of transcranial Doppler sonography, near-infrared spectroscopy, stump pressure, and somatosensory evoked potentials. Anesthesiology. 2007 Oct;107(4):563-9. doi: 10.1097/01.anes.0000281894.69422.ff.

Reference Type BACKGROUND
PMID: 17893451 (View on PubMed)

Kamenskaya O, Klinkova A, Loginova I, Lomivorotov VV, Shmyrev V, Chernyavskiy A. Brain Oxygen Supply in Older Adults During Coronary Artery Bypass Grafting. J Cardiothorac Vasc Anesth. 2020 Dec;34(12):3275-3281. doi: 10.1053/j.jvca.2020.04.053. Epub 2020 May 14.

Reference Type BACKGROUND
PMID: 32532692 (View on PubMed)

Adedipe AA, Fly DL, Schwitz SD, Jorgenson DB, Duric H, Sayre MR, Nichol G. Carotid Doppler blood flow measurement during cardiopulmonary resuscitation is feasible: A first in man study. Resuscitation. 2015 Nov;96:121-5. doi: 10.1016/j.resuscitation.2015.07.024. Epub 2015 Jul 30.

Reference Type BACKGROUND
PMID: 26234896 (View on PubMed)

Gaspari R, Weekes A, Adhikari S, Noble V, Nomura JT, Theodoro D, Woo M, Atkinson P, Blehar D, Brown S, Caffery T, Douglass E, Fraser J, Haines C, Lam S, Lanspa M, Lewis M, Liebmann O, Limkakeng A, Lopez F, Platz E, Mendoza M, Minnigan H, Moore C, Novik J, Rang L, Scruggs W, Raio C. A retrospective study of pulseless electrical activity, bedside ultrasound identifies interventions during resuscitation associated with improved survival to hospital admission. A REASON Study. Resuscitation. 2017 Nov;120:103-107. doi: 10.1016/j.resuscitation.2017.09.008. Epub 2017 Sep 13.

Reference Type BACKGROUND
PMID: 28916478 (View on PubMed)

Murkin JM, Adams SJ, Novick RJ, Quantz M, Bainbridge D, Iglesias I, Cleland A, Schaefer B, Irwin B, Fox S. Monitoring brain oxygen saturation during coronary bypass surgery: a randomized, prospective study. Anesth Analg. 2007 Jan;104(1):51-8. doi: 10.1213/01.ane.0000246814.29362.f4.

Reference Type BACKGROUND
PMID: 17179242 (View on PubMed)

Rudolph JL, Sorond FA, Pochay VE, Haime M, Treanor P, Crittenden MD, Babikian VL. Cerebral hemodynamics during coronary artery bypass graft surgery: the effect of carotid stenosis. Ultrasound Med Biol. 2009 Aug;35(8):1235-41. doi: 10.1016/j.ultrasmedbio.2009.04.008. Epub 2009 Jun 21.

Reference Type BACKGROUND
PMID: 19540657 (View on PubMed)

Lewis C, Parulkar SD, Bebawy J, Sherwani S, Hogue CW. Cerebral Neuromonitoring During Cardiac Surgery: A Critical Appraisal With an Emphasis on Near-Infrared Spectroscopy. J Cardiothorac Vasc Anesth. 2018 Oct;32(5):2313-2322. doi: 10.1053/j.jvca.2018.03.032. Epub 2018 Mar 20.

Reference Type BACKGROUND
PMID: 30100271 (View on PubMed)

Baldi E, Caputo ML, Klersy C, Benvenuti C, Contri E, Palo A, Primi R, Cresta R, Compagnoni S, Cianella R, Burkart R, De Ferrari GM, Auricchio A, Savastano S. End-tidal carbon dioxide (ETCO2) at intubation and its increase after 10 minutes resuscitation predicts survival with good neurological outcome in out-of-hospital cardiac arrest patients. Resuscitation. 2022 Dec;181:197-207. doi: 10.1016/j.resuscitation.2022.09.015. Epub 2022 Sep 24.

Reference Type BACKGROUND
PMID: 36162612 (View on PubMed)

Lomivorotov VV, Efremov SM, Kirov MY, Fominskiy EV, Karaskov AM. Low-Cardiac-Output Syndrome After Cardiac Surgery. J Cardiothorac Vasc Anesth. 2017 Feb;31(1):291-308. doi: 10.1053/j.jvca.2016.05.029. Epub 2016 Jul 29. No abstract available.

Reference Type BACKGROUND
PMID: 27671216 (View on PubMed)

Polzl L, Thielmann M, Cymorek S, Nagele F, Hirsch J, Graber M, Sappler N, Eder J, Staggl S, Theurl F, Abfalterer H, Reinstadler SJ, Holfeld J, Griesmacher A, Ulmer H, Grimm M, Bauer A, Ruttmann-Ulmer E, Ruhparwar A, Bonaros N, Gollmann-Tepekoylu C. Impact of myocardial injury after coronary artery bypass grafting on long-term prognosis. Eur Heart J. 2022 Jul 1;43(25):2407-2417. doi: 10.1093/eurheartj/ehac054.

Reference Type BACKGROUND
PMID: 35139192 (View on PubMed)

Anyanwu AC, Filsoufi F, Salzberg SP, Bronster DJ, Adams DH. Epidemiology of stroke after cardiac surgery in the current era. J Thorac Cardiovasc Surg. 2007 Nov;134(5):1121-7. doi: 10.1016/j.jtcvs.2007.06.031.

Reference Type BACKGROUND
PMID: 17976438 (View on PubMed)

Eberle B, Dick WF, Schneider T, Wisser G, Doetsch S, Tzanova I. Checking the carotid pulse check: diagnostic accuracy of first responders in patients with and without a pulse. Resuscitation. 1996 Dec;33(2):107-16. doi: 10.1016/s0300-9572(96)01016-7.

Reference Type BACKGROUND
PMID: 9025126 (View on PubMed)

Moule P. Checking the carotid pulse: diagnostic accuracy in students of the healthcare professions. Resuscitation. 2000 May;44(3):195-201. doi: 10.1016/s0300-9572(00)00139-8.

Reference Type BACKGROUND
PMID: 10825620 (View on PubMed)

Soar J, Bottiger BW, Carli P, Couper K, Deakin CD, Djarv T, Lott C, Olasveengen T, Paal P, Pellis T, Perkins GD, Sandroni C, Nolan JP. European Resuscitation Council Guidelines 2021: Adult advanced life support. Resuscitation. 2021 Apr;161:115-151. doi: 10.1016/j.resuscitation.2021.02.010. Epub 2021 Mar 24.

Reference Type BACKGROUND
PMID: 33773825 (View on PubMed)

Suriani I, van Houte J, de Boer EC, van Knippenberg L, Manzari S, Mischi M, Bouwman RA. Carotid Doppler ultrasound for non-invasive haemodynamic monitoring: a narrative review. Physiol Meas. 2023 Mar 1;43(10). doi: 10.1088/1361-6579/ac96cb.

Reference Type BACKGROUND
PMID: 36179705 (View on PubMed)

van Houte J, Mooi FJ, Montenij LJ, Meijs LPB, Suriani I, Conjaerts BCM, Houterman S, Bouwman AR. Correlation of Carotid Doppler Blood Flow With Invasive Cardiac Output Measurements in Cardiac Surgery Patients. J Cardiothorac Vasc Anesth. 2022 Apr;36(4):1081-1091. doi: 10.1053/j.jvca.2021.09.043. Epub 2021 Oct 5.

Reference Type BACKGROUND
PMID: 34756675 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 38404755 (View on PubMed)

Faldaas 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.

Reference Type BACKGROUND
PMID: 37448689 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CIV-NO-23-10-04

Identifier Type: OTHER

Identifier Source: secondary_id

656036

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.