Post Cardiac Surgery Hemodynamics Diagnostic Device

心脏手术后血流动力学诊断装置

• 批准号: 10256581
• 负责人: Anil Kottam
• 金额: $ 25.65万
• 依托单位: BRIDGESOURCE MEDICAL CORPORATION
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-07-01 至 2022-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10256581
• 关键词: Acute Kidney Failure; Age; Aged, 80 and over; American; Animals; Antihypertensive Agents; Blood Volume; Bypass; Cardiac; Cardiac Surgery procedures; Cardiac Tamponade; Cardiac Volume; Cardiovascular system; Caregivers; Catheters; Chest; Clinical; Clinical Research; Clinical Trials; Connective Tissue; Coronary; Dangerousness; Detection; Development; Devices; Diagnosis; Diagnostic; Dialysis procedure; Differential Diagnosis; Discrimination; Doctor of Philosophy; Drainage procedure; Electrodes; Engineering; Ensure; Epicardium; Evaluation Studies; Family suidae; Health; Heart; Heart failure; Hospitals; Human; Hypotension; Hypovolemia; Implant; Incidence; Infection; Intensive Care Units; Kidney; Knowledge; Lead; Liquid substance; Low Cardiac Output; Measurement; Measures; Medical; Modification; Monitor; Morbidity - disease rate; Morphology; Myocardium; Octogenarian; Operative Surgical Procedures; Outcome; Patients; Performance; Pericardial body location; Phase; Population; Postoperative Period; Principal Investigator; Procedures; Pulmonary artery structure; Recovery; Research; Research Personnel; Resources; Risk; Safety; Small Business Innovation Research Grant; Specialist; Sternotomy; Surface; System; Systems Development; Testing; Time; Tube; United States National Institutes of Health; Vascular blood supply; Work; age related; aging population; clinical efficacy; clinically actionable; design; empowered; flexibility; heart damage; hemodynamics; high risk; hospital readmission; human old age (65+); implantation; improved; manufacturability; mortality; new technology; novel; older patient; pericardial sac; pre-clinical; preclinical study; pressure; prevent; prophylactic; prototype; response; touchscreen; valve replacement; verification and validation

Abstract Coronary arterial bypass graft (CABG) and valve replacements are open-heart surgeries that are performed on 400,000 Americans each year. The average age of cardiac surgery patients is early 60s, with 52% over the age of 65, and 8% over the age of 80. Octogenarians are increasingly being referred for cardiac surgery, because the aging population is increasing rapidly, and they still benefit enough from CABG to improve long term survival despite higher risk. However, they also have longer post-operative stays in ICU and hospital, and higher rates of ICU readmission. Unexplained hypotension in this population is of particular concern during recovery, because although pressures are routinely measured continuously, discrimination between proper treatment courses requires an additional measure of heart volumes. The previous standard for volume management (a partially implanted Pulmonary Artery Catheter, or PAC) is now considered too risky for prophylactic implantation due to the added risks of another invasive procedure, infection, lack of evidence that it changes outcomes. Without information on volume status, multiple day recovery with only minimal bedside hospital staff present makes the proper diagnosis and rapid treatment of unexplained hypotension tricky. In the older cardiac surgery patient, age-related modifications in cardiac morphology result in decreased contractile reserve, reduced compliance, and blunted inotropic response. This leads to hypotensive situations where the proper diagnosis of cardiac damage or weakness can be confused with low volume status (hypovolemia) and reduced vessel compliance requiring exploratory surgery. All unsure staff in this situation prudently call for an echo, the resident fellow, or other available cardiovascular specialists to infer what the volume is while the patient’s hypotensive state persists, increasing risk. BSM proposes to modify the ubiquitously placed pericardial drain to discriminate among these two states without a PAC, by using a novel, clinically-validated volume measurement, empowering staff to take the proper clinical course of action quickly to stabilize elderly patients.

摘要 冠状动脉旁路移植术(CABG)和瓣膜置换术是一种心脏直视手术， 每年在40万美国人身上进行。心脏手术患者的平均年龄是 60岁出头，其中52%的人65岁以上，8%的人80岁以上。八十多岁的人 越来越多的人被转介接受心脏手术，因为老龄化人口正在增加 迅速，他们仍然从冠脉搭桥术中受益足够多，以提高长期生存率，尽管 风险。然而，他们也有更长的术后在ICU和医院的停留时间，以及更高的死亡率 再次住进重症监护室。这一人群中不明原因的低血压尤其令人担忧 复苏，因为尽管压力经常被连续测量，但歧视 在适当的疗程之间，需要额外测量心脏体积。这个 以前的容量管理标准(部分植入的肺动脉导管，或 PAC)现在被认为对预防性植入来说风险太大，因为另一种 侵入性手术，感染，缺乏改变结果的证据。没有关于的信息 容量状况，多天恢复，只有最少的床边医院工作人员在场，使 不明原因低血压的正确诊断和快速治疗是棘手的。在较老的心脏中 手术患者，与年龄相关的心脏形态改变导致收缩功能下降 储备减少，依从性降低，变力反应迟钝。这会导致低血压 对心脏损伤或虚弱的正确诊断可能与低血压混淆的情况 容量状态(低血容量)和需要探查手术的血管顺应性降低。全 在这种情况下，不确定的工作人员会谨慎地要求Echo、常驻研究员或其他有空人员 心血管专家推断患者的低血压状态时的容量 持续存在，增加了风险。BSM建议修改无处不在的心包引流管，以 在没有PAC的情况下区分这两种状态，使用一种新的、经临床验证的 体量测量，使工作人员能够迅速采取适当的临床行动方案 稳定老年患者。