Post Cardiac Surgery Hemodynamics Diagnostic Device

心脏手术后血流动力学诊断装置

基本信息

批准号：
10453483
负责人：
Anil Kottam
金额：
$ 74.03万
依托单位：
BRIDGESOURCE MEDICAL CORPORATION
依托单位国家：
美国
项目类别：
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/10453483
关键词：
Acute Kidney Failure Age Aged, 80 and over American Animals 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 Diagnostic Equipment 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 Hypotensives 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

项目摘要

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.

抽象的冠状动脉旁路移植术 (CABG) 和瓣膜置换术是心脏直视手术，每年对 400,000 名美国人进行心脏手术患者的平均年龄是 60 岁出头，其中 52% 年龄在 65 岁以上，8% 年龄在 80 岁以上。由于人口老龄化不断加剧，越来越多的人被转诊接受心脏手术尽管较高，但他们仍然可以从 CABG 中受益，以改善长期生存然而，他们术后在 ICU 和医院停留的时间也更长，发生率也更高。该人群中不明原因的低血压再次入院的情况尤其值得关注。恢复，因为虽然压力是连续测量的，但歧视在正确的治疗过程之间需要额外测量心脏容量。先前的容量管理标准（部分植入的肺动脉导管，或 PAC）现在被认为对于预防性植入来说风险太大，因为另一种风险增加了侵入性操作、感染、缺乏证据表明它会改变结果，但没有相关信息。容量状态，多天恢复，只有最少的床边医院工作人员在场，使得正确诊断和快速治疗不明原因的低血压对于老年人来说是棘手的。手术患者，年龄相关的心脏形态改变导致收缩力下降储备、顺应性降低和正性肌力反应减弱，这会导致低血压。心脏损伤或虚弱的正确诊断可能与心脏功能低下相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。在这种情况下，不确定的工作人员应谨慎地寻求回声、常驻研究员或其他可用的人员心血管专家在患者处于低血压状态时推断出容量是多少 BSM 建议修改普遍放置的心包引流管，以增加风险。通过使用一种新颖的、经过临床验证的方法，在没有 PAC 的情况下区分这两个州体积测量，使工作人员能够快速采取适当的临床行动方案稳定老年患者。