Impedance Threshold Value for Improving Standard CPR

改善标准心肺复苏的阻抗阈值

• 批准号: 7188538
• 负责人: KEITH G LURIE
• 金额: $ 101.5万
• 依托单位: ADVANCED CIRCULATORY SYSTEMS, INC.
• 依托单位国家: 美国
• 财政年份: 2000
• 资助国家: 美国
• 起止时间: 2000-09-15 至 2010-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7188538
• 关键词: Admission activity; Adult; Affect; American; American Heart Association; Animal Experimentation; Animal Model; Animals; Atmospheric Pressure; Attention; Blinded; Blood; Blood Circulation; Blood Pressure; Blood flow; Brain; Cardiac; Cardiac Death; Cardiology; Cardiopulmonary Resuscitation; Categories; Cerebral perfusion pressure; Cerebrovascular Circulation; Cerebrum; Certification; Cessation of life; Chest; Chest wall structure; Clinical; Clinical Data; Clinical Research; Clinical Trials; Communication; Companions; Control Groups; Coronary; Data; Decompressive incision; Device Designs; Devices; Diastolic blood pressure; Documentation; Double-Blind Method; Electric Countershock; Emergency medical service; Employee Strikes; End Point; Enrollment; Environmental air flow; European; Exhalation; Feedback; Gases; Goals; Guidelines; Hand; Heart; Heart Arrest; High Blood Pressure; Home environment; Hospitals; Hour; Hyperventilation; Intensive Care Units; International; Intrinsic factor; Intubation; Laboratories; Lead; Learning; Life; Light; Manikins; Manuals; Marketing; Mechanics; Methods; Modification; Monitor; Nervous System Physiology; Numbers; Organ; Outcome; Paramedical Personnel; Patient Discharge; Patients; Performance; Perfusion; Phase; Phase II Clinical Trials; Positioning Attribute; Practice Guidelines; Principal Investigator; Randomized; Rate; Recommendation; Relative (related person); Relaxation; Research; Research Personnel; Respiratory Diaphragm; Rest; Restart; Secondary to; Silicones; Site; Small Business Funding Mechanisms; Small Business Innovation Research Grant; Standards of Weights and Measures; Statistically Significant; Subgroup; Suction; Survival Rate; Survivors; System; Techniques; Technology; Testing; Time; Time Study; Training; United States; United States Food and Drug Administration; Vacuum; Venous; Ventricular Fibrillation; Wisconsin; base; college; concept; coronary perfusion; day; design; electric impedance; external Decompression; falls; follow-up; heart rhythm; hemodynamics; hospital discharge rate; improved; innovation; intratracheal pressure; outcome forecast; pressure; prevent; programs; prospective; respiratory gas

DESCRIPTION (provided by applicant): Despite the widespread practice of basic and advanced life support, over 1000 patients die each day in the United States from an out-of-hospital cardiac arrest. Even though they receive standard cardiopulmonary resuscitation (sCPR) the average national survival to hospital discharge for these patients is less than 5%. The applicants have developed the inspiratory impedance threshold device (ITD) to increase negative intrathoracic pressure during the decompression phase of sCPR, thereby doubling forward blood flow. The Phase 2 clinical trial demonstrated that intensive care unit admission rate (primary study endpoint) in patients with an initial heart rhythm of pulseless electrical activity increased from 19% to 52% (p=0.02). During Phase 2 investigators also discovered a fundamental new principle of blood flow during CPR: an inverse relationship between intrathoracic pressure and coronary perfusion pressure as well as cerebral perfusion pressure and survival rates. With increased intrathoracic pressure, coronary and cerebral perfusion pressures, as well as survival rates, decreased. The Phase 2 research further lead to the discovery that during sCPR ventilation rates and duration are often excessive and that the chest is often not allowed to fully recoil after each compression. Each of these common clinical errors was electronically recorded for the first time and then shown to be detrimental, if not deadly, in animal models of cardiac arrest. Based upon these Phase II results the applicants have improved the ITD by adding a ventilation timing light to guide proper ventilation and developed a new and improved hand position for sCPR to help promote full chest wall recoil. Another way to assure that the critically important full chest recoil occurs after each chest compression is by using active compression decompression (ACD) CPR, a technique also developed by the applicants that utilizes a hand held device. Based upon these Phase 2 results, the Phase 2 continuation research will be conducted to obtain sufficient clinical data for regulatory clearance for the ITD as a technology intended to improve 24-hour survival rates after cardiac arrest. A pivotal clinical trial is proposed in the form of a prospective, randomized, two-site clinical trial to: 1) determine the 24-hour survival rate when using the ITD with improved sCPR, and 2) to determine the 24-hour survival rate when using the ITD and assuring full chest wall recoil with ACD CPR. With 400,000 out-of-hospital deaths from cardiac arrest in the United States alone, widespread application of this technology could result in 50,000 additional survivors per year.

描述（由申请人提供）： 尽管基本和高级生命支持的广泛实践，在美国每天有超过1000名患者死于院外心脏骤停。即使他们接受了标准的心肺复苏术（sCPR），这些患者的平均出院存活率也不到5%。申请人已经开发了吸气阻抗阈值装置（ITD），以在sCPR的减压阶段期间增加负胸内压，从而使前向血流加倍。II期临床试验表明，初始心律为无脉性电活动的患者的重症监护室入院率（主要研究终点）从19%增加到52%（p=0.02）。在第二阶段，研究人员还发现了心肺复苏术中血流的一个基本新原理：胸内压与冠状动脉灌注压以及脑灌注压与存活率之间存在反比关系。随着胸内压的增加，冠状动脉和脑灌注压以及存活率下降。第2阶段研究进一步发现，在sCPR期间，通气速率和持续时间通常过大，并且每次按压后胸部通常不允许完全回缩。 这些常见的临床错误中的每一个都首次被电子记录下来，然后在心脏骤停的动物模型中被证明是有害的，如果不是致命的话。基于这些第II阶段结果，申请人通过添加通气定时灯来改进ITD以引导适当通气，并开发了用于sCPR的新的和改进的手部位置以帮助促进完全胸壁回缩。另一种确保在每次胸部按压之后发生至关重要的完全胸部回缩的方式是通过使用主动按压减压（ACD）CPR，这也是由申请人开发的利用手持装置的技术。基于这些II期结果，将进行II期继续研究，以获得ITD作为一种旨在提高心脏骤停后24小时存活率的技术的监管许可所需的足够临床数据。提出了一项前瞻性、随机、双中心临床试验形式的关键性临床试验，以：1）确定使用ITD和改进的sCPR时的24小时存活率，2）确定使用ITD并通过ACD CPR确保完全胸壁回缩时的24小时存活率。仅在美国就有40万人死于心脏骤停，广泛应用这项技术每年可能会增加5万名幸存者。