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

NCT06637540 | Completed DMC

• 2 other identifiers: 656036CIV-NO-23-10-04
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 3

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 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.

Conditions

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

Keywords

Handsfree Doppler Ultrasound; RescueDoppler; Pulsed wave Doppler Ultrasound; Cardiopulmonary bypass; Continous blood flow velocities in Cardiopulmonary bypass

Outcome Measures

Primary Outcomes (2)

• Assessment of the velocity- time integral (the area under the blood flow curve in cm) at 25%, 50% and 75% decrease/increase in pulsatile blood flow.

  The primary objective is to assess the continuous blood flow signals in the left common carotid artery measured by the RescueDoppler device in a clinical setting in subjects undergoing planned circulatory changes from pulsatile- to non-pulsatile blood flow when initiating- and back when weaning from CPB. The primary endpoint as described in the Title.

  From enrolment to the end after 11 months

• Limits of agreement between peak systolic velocity (PSV in cm/sec) between conventional Doppler Ultrasound and RescueDoppler

  The objective is to evaluate if the RescueDoppler is noninferior to conventional Doppler ultrasound by comparing flow pattern and velocities by the two methods.

  From enrolment to the end after 11 months

Secondary Outcomes (7)

• Peak systolic velocity (PSV) in cm/s in correlation to a 25%,50%, 75% and 100% decrease/increase in pulsatile blood flow

  From enrolment to the end after 11 months

• The correlation between VTI and pulse pressure

  From enrolment to the end after 11 months

• The correlation between PSV in cm/s and pulse pressure

  From enrolment to the end after 11 months

• The velocity time integral (VTI)

  From enrolment to the end after 11 months

• Systolic and diastolic velocities in cm/s

  From enrolment to the end after 11 months

Study Arms (1)

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

EXPERIMENTAL

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.

Device: RescueDoppler

Interventions

RescueDoppler DEVICE

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

Also known as: RD, Carotid Pulsed waved Doppler, Carotid Doppler, Continous Carotid Doppler

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Accepted for cardiac-, valve- and aortic surgery
• Circulatory stable
• Male and female
• any BMI
• Age 18-80

You may not qualify if:

• Significant left carotid artery stenosis (\> 50%)
• Carotid stent or has had surgery to the left carotid artery
• Emergency surgery
• Hemodynamic unstable

Sponsors & Collaborators

• St. Olavs Hospital: lead

Study Sites (3)

St. Oalvs Hospital, Trondheim University Hospital

Trondheim, 7020, Norway

Location

St.Olavs Hospital, Trondheim University Hospital

Trondheim, 7020, Norway

Location

St. Olavs Hospital, Trondheim University Hospital

Trondheim, 7030, Norway

Location

Related Publications (18)

• 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.

  PMID: 17893451 BACKGROUND

• 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.

  PMID: 32532692 BACKGROUND

• 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.

  PMID: 26234896 BACKGROUND

• 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.

  PMID: 28916478 BACKGROUND

• 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.

  PMID: 17179242 BACKGROUND

• 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.

  PMID: 19540657 BACKGROUND

• 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.

  PMID: 30100271 BACKGROUND

• 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.

  PMID: 36162612 BACKGROUND

• 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.

  PMID: 27671216 BACKGROUND

• 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.

  PMID: 35139192 BACKGROUND

• 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.

  PMID: 17976438 BACKGROUND

• 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.

  PMID: 9025126 BACKGROUND

• 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.

  PMID: 10825620 BACKGROUND

• 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.

  PMID: 33773825 BACKGROUND

• 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.

  PMID: 36179705 BACKGROUND

• 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.

  PMID: 34756675 BACKGROUND

• 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.

  PMID: 38404755 BACKGROUND

• 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.

  PMID: 37448689 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Aortic Valve Disease

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2024
• First Posted: October 15, 2024
• Study Start: January 28, 2024
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: November 4, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF, CSR
• Time Frame: Starting 6 months after the publication of results and ending 2 years later
• Access Criteria: A data sharing agreement must be signed and submitted to the steering committee, which includes the Principal Investigator (PI), Sponsor and Site Investigator (SI) from the hospital in the study.

Locations

NO (3)