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：
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
项目类别：
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

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物（CABG）和瓣膜更换是开心的手术每年对40万美国人进行。心脏手术患者的平均年龄是 60年代初，有52％超过65岁，80岁以上的8％。八十岁的人是越来越多地提到心脏手术，因为人口的老龄化正在增加迅速，他们仍然从CABG中受益足以提高长期生存目的地风险。但是，它们在ICU和医院的术后住院时间也更长，并且较高的比率 ICU再入院。在这个人群中无法解释的低血压在恢复，因为通常会连续测量压力，以歧视在适当的治疗课程之间需要额外的心脏体积量度。这先前的体积管理标准（部分植入的肺动脉导管或 PAC）现在认为由于另一个人的额外风险而被认为对于预防性植入太冒险了侵入性程序，感染，缺乏改变结果的证据。没有信息数量状态，仅在场的最少床旁医院工作人员的多天恢复使得适当的诊断和快速治疗意外的低血压棘手。在较老的心脏手术患者，与年龄相关的心脏形态修饰可改善收缩储备，降低依从性和蓝色肌力反应。这导致降低适当诊断心脏损伤或无力的情况可能会与低相混淆体积状态（低血容量）和需要探索性手术的血管合规性。全部在这种情况下，不确定的员工谨慎地呼吁一个回声，居民或其他可用的心血管专家可以推断出患者降压状态时的体积持续存在，增加风险。 BSM提议将无处不在的心包流水器修改为通过使用新颖的临床验证，在没有PAC的这两个状态下区分这两个状态数量测量，使员工能够快速采取适当的临床行动方向稳定老患者。