Post Cardiac Surgery Hemodynamics Diagnostic Device

心脏手术后血流动力学诊断装置

• 批准号: 10707900
• 负责人: Anil Kottam
• 金额: $ 95.89万
• 依托单位: BRIDGESOURCE MEDICAL CORPORATION
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-30 至 2024-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10707900
• 关键词: Acute Kidney Failure; Age; Aged, 80 and over; American; Animals; Blood Volume; Bypass; Cardiac; Cardiac Surgery procedures; Cardiac Volume; Cardiovascular system; Caregivers; Catheters; Chest; Clinical; Clinical Research; Clinical Trials; Confusion; Connective Tissue; Coronary; Dangerousness; Detection; Development; Devices; Diagnosis; Diagnostic; Diagnostic Equipment; Dialysis procedure; Differential Diagnosis; Discrimination; Doctor of Philosophy; Drainage procedure; Electrodes; Electronics; Engineering; Ensure; Epicardium; Evaluation Studies; Family suidae; Health; Heart; Heart failure; Hospitals; Human; Hypotension; Hypotensives; Hypovolemia; Hypovolemics; Implant; Incidence; Infection; Intensive Care Units; Kidney; Knowledge; Liquid substance; Low Cardiac Output; Marketing; 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; Qualifying; Recovery; Research; Research Personnel; Resources; Risk; Safety; Small Business Innovation Research Grant; Specialist; Specific qualifier value; 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; empowerment; flexibility; heart damage; hemodynamics; high risk; hospital readmission; human old age (65+); implantation; improved; invention; 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）和瓣膜置换术是心内直视手术， 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，65岁以上占52%，80岁以上占8%。阿根廷人是 越来越多的人被转诊接受心脏手术，因为人口老龄化正在增加 他们仍然从CABG中受益，以提高长期生存率，尽管他们的年龄更高， 风险然而，他们也有更长的术后停留在ICU和医院， ICU再入院在这一人群中，不明原因的低血压尤其值得关注， 恢复，因为虽然压力是经常连续测量，歧视， 在适当的治疗疗程之间需要额外测量心脏体积。的 容量管理的先前标准（部分植入的肺动脉导管，或 PAC）现在被认为是太危险的预防性植入，由于另一个额外的风险 侵入性操作，感染，缺乏证据表明它会改变结果。没决定机 容量状态，多天恢复，只有最少的床边医院工作人员在场， 正确诊断和快速治疗原因不明的低血压棘手。在老年心脏病患者中， 手术患者，年龄相关心脏形态改变导致收缩功能降低， 储备，降低的顺应性和减弱的正性肌力反应。这导致了过度的 心脏损伤或虚弱的正确诊断可能与低血糖混淆的情况。 容量状态（血容量不足）和血管顺应性降低，需要进行探查手术。所有 在这种情况下，不确定的工作人员会谨慎地要求回声，常驻研究员或其他可用的 心血管专家来推断当病人处于昏迷状态时， 持续存在，增加风险。BSM建议修改无处不在的心包引流管， 在没有PAC的情况下，通过使用一种新的、临床验证的 体积测量，使工作人员能够迅速采取适当的临床行动， 稳定老年患者。