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临床试验/NCT06637540
NCT06637540已完成不适用

Clinical Validation of a Novel Ultrasound Probe (RescueDoppler) During Physiological Perturbations and Initiation Of- and Weaning from Cardiopulmonary Bypass in Adult, Cardiac Surgery Patients

St. Olavs Hospital6 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2024年1月28日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
42
试验地点
6
主要终点
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.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Accepted for cardiac-, valve- and aortic surgery
  • Circulatory stable
  • Male and female

排除标准

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

结局指标

主要结局

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.

时间窗: From enrolment to the end after 11 months

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.

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

时间窗: From enrolment to the end after 11 months

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

次要结局

  • 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)
  • Pulsatile index (PI)(From enrolment to the end after 11 months)
  • Incidence of Treatment-Emergent Adverse Events(From enrolment to the end after 11 months)

研究者

发起方
St. Olavs Hospital
申办方类型
Other
责任方
Sponsor

研究点 (6)

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