Impedance Threshold Value for Improving Standard CPR

改善标准心肺复苏的阻抗阈值

• 批准号: 7538242
• 负责人: KEITH G LURIE
• 金额: $ 149.09万
• 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/7538242
• 关键词: Abdomen; Accounting; Admission activity; Adult; Affect; American Heart Association; Animal Experimentation; Animals; Attitude; Award; Blinded; Blood; Blood Circulation; Blood Pressure; Blood flow; Brain; Breathing; Cardiac; Cardiac Death; Cardiopulmonary Resuscitation; Cardiovascular system; Caring; Cerebrovascular Circulation; Cerebrum; Cessation of life; Chest; Chest wall structure; Child; Cities; Clinical; Clinical Data; Clinical Research; Clinical Trials; Clinical Trials Data Monitoring Committees; Complication; Control Groups; Coronary; County; Data; Decompressive incision; Device Designs; Devices; Diastolic blood pressure; Distal; Double-Blind Method; Effectiveness; Emergency medical service; Employee Strikes; End Point; Enrollment; Environmental air flow; Etiology; European; Exhalation; Family suidae; Feedback; Fracture; Frequencies; Funding; Gases; Goals; Grant; Guidelines; Hand; Heart; Heart Arrest; Home environment; Hospitals; Hour; Human; Hyperventilation; Informed Consent; Intensive Care Units; Intervention; Intracranial Pressure; Intrinsic factor; Intubation; Lead; Leadership; Learning; Life; Light; Manikins; Manuals; Marketing; Mechanics; Methods; Modification; Nervous System Physiology; Neurologic; Numbers; Organ; Outcome; Patient Discharge; Patients; Performance; Perfusion; Pharmaceutical Preparations; Phase; Phase II Clinical Trials; Positioning Attribute; Principal Investigator; Protocols documentation; Public Health; Randomized; Range; Rate; Recommendation; Relative (related person); Relaxation; Reporting; Research; Research Design; Research Ethics Committees; Research Personnel; Resistance; Rest; Resuscitation; Role; Sample Size; Score; Secondary to; Site; Small Business Funding Mechanisms; Small Business Innovation Research Grant; Standards of Weights and Measures; Statistically Significant; Subgroup; Suction; Survival Rate; Survivors; Sus scrofa; System; Techniques; Technology; Tetradecanoylphorbol Acetate; Therapeutic; Therapeutic Uses; Thinking; Time; Time Study; Training; Tube; United States; United States Food and Drug Administration; United States National Institutes of Health; Upper arm; Vacuum; Venous; Ventricular Fibrillation; Work; Writing; base; commercialization; concept; day; design; electric impedance; emergency service responder; external Decompression; face mask; follow-up; heart rhythm; hemodynamics; hospital discharge rate; human study; improved; inclusion criteria; innovation; mortality; natural hypothermia; new technology; novel; novel strategies; pressure; prevent; programs; prospective; research clinical testing; rib bone structure; size; sudden cardiac death; tool; trend; trial comparing

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 remains <5%. The applicants have developed two new CPR devices, the inspiratory impedance threshold device (ITD) and an active compression decompression (ACD) CPR device that together quadruple blood flow to the heart and brain when used in combination and compared with sCPR. The ITD is the size of a child's fist and it is attached to the airway via a face mask or breathing tube. The ACD CPR is a hand-held device that compresses the chest like a pair of hands but facilitates active and full chest wall recoil as it has a suction cup that attaches to the chest. These devices work synergistically by increasing the extent and duration of negative intrathoracic pressure or intrathoracic vacuum during the chest wall recoil phase of sCPR, thereby more effectively refilling the heart after each chest compression. The Phase 2 clinical trial, which was focused only on the ITD + sCPR, 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). 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 follow-up animal studies on cardiac arrest. Based upon these Phase 2 results the applicants improved the ITD by adding a ventilation timing light to guide proper ventilation and added ACD CPR to the study design to assure that the critically important full chest recoil occurs after each chest. Building upon the Phase 2 results, the Phase 2 Continuation research is being conducted to obtain sufficient clinical data for regulatory clearance for the ITD and ACD CPR as a technology intended to improve hospital discharge and 30 day neurologically-intact survival after cardiac arrest. Funding is being request to complete a pivotal SBIR Phase 2 Continuation study comparing sCPR versus ACD CPR + the ITD designed as a prospective, randomized, 1400 patient, 6-site clinical trial. Hospital discharge with good neurological function is the primary endpoint and survivors will be followed for up to one year. With 400,000 out-of-hospital deaths from cardiac arrest in the United States alone, widespread application of this technology could result in more than 50,000 neurologically-intact survivors per year. PUBLIC HEALTH RELEVANCE This SBIR Phase 2 Continuation research is primarily intended to obtain sufficient clinical data for regulatory clearance for the combination of an impedance threshold device (ITD, ResQPOD.) and an active compression decompression CPR device (ACD CPR, ResQPump.) as a technology intended to improve 30 day intact neurological survival after cardiac arrest. A pivotal clinical trial is proposed in the form of a prospective, randomized, 1400 patient, six-site clinical trial to determine the 30 day survival rate with intact neurologic function when using the ITD and assuring full chest wall recoil with ACD CPR compared to sCPR alone. If this program is successful, the new resuscitation system has the potential to resuscitate approximately 50,000 more patients of the 400,000 sudden cardiac deaths that occur outside the hospital each year in the United States.

描述（由申请人提供）：尽管基本和高级生命支持的广泛实践，但在美国每天有超过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（sCPR），这些患者的平均出院存活率仍低于5%。申请人已经开发了两种新的CPR设备，吸气阻抗阈值设备（ITD）和主动压缩减压（ACD）CPR设备，当组合使用并与sCPR相比时，这两种设备一起使流向心脏和大脑的血流增加四倍。ITD是一个孩子的拳头大小，它是通过面罩或呼吸管连接到气道。ACD CPR是一种手持式设备，它像一双手一样按压胸部，但由于它有一个连接到胸部的吸盘，因此有助于主动和全面的胸壁反冲。这些装置通过在sCPR的胸壁回缩阶段期间增加胸内负压或胸内真空的程度和持续时间来协同工作，从而在每次胸部按压之后更有效地再填充心脏。仅关注ITD + sCPR的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%增加至52%（p=0.02）。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是第一次被电子记录下来的，然后在心脏骤停的后续动物研究中被证明是有害的，如果不是致命的话。基于这些第2阶段结果，申请人通过添加通气定时灯以指导适当通气来改进ITD，并在研究设计中添加ACD CPR，以确保在每次胸部后发生至关重要的全胸部回缩。在II期研究结果的基础上，正在进行II期继续研究，以获得足够的临床数据，用于ITD和ACD CPR的监管许可，作为一种旨在改善心脏骤停后出院和30天神经系统完整生存率的技术。正在申请资金以完成一项关键性SBIR II期继续研究，该研究比较了sCPR与ACD CPR + ITD，设计为一项前瞻性、随机、1400例患者、6个中心的临床试验。出院时神经功能良好是主要终点，幸存者将接受长达一年的随访。仅在美国就有40万人死于心脏骤停，这项技术的广泛应用每年可能导致超过5万名神经系统完好的幸存者。公共卫生相关性本SBIR第2阶段继续研究主要旨在获得足够的临床数据，以获得阻抗阈值器械（ITD，ResQPOD）组合的监管许可。和主动按压减压CPR设备（ACD CPR、ResQPump。）作为一种旨在提高心脏骤停后30天完整神经存活率的技术。提出了一项前瞻性、随机、1400例患者、6个中心临床试验的关键性临床试验，以确定与单独sCPR相比，使用ITD并确保ACD CPR的完全胸壁回缩时，神经功能完好的30天生存率。如果这个项目成功，新的复苏系统有可能使美国每年发生在医院外的40万心脏猝死患者中的大约5万人复苏。

项目成果

Death by hyperventilation: a common and life-threatening problem during cardiopulmonary resuscitation.

• DOI: 10.1097/01.ccm.0000134335.46859.09
• 发表时间: 2004-09-01
• 期刊: Critical care medicine
• 影响因子: 8.8
• 作者: Aufderheide, Tom P;Lurie, Keith G
• 通讯作者: Lurie, Keith G

Treatment of non-traumatic out-of-hospital cardiac arrest with active compression decompression cardiopulmonary resuscitation plus an impedance threshold device.

• DOI: 10.1016/j.resuscitation.2013.05.002
• 发表时间: 2013-09
• 期刊: Resuscitation
• 影响因子: 6.5
• 作者: Frascone RJ;Wayne MA;Swor RA;Mahoney BD;Domeier RM;Olinger ML;Tupper DE;Setum CM;Burkhart N;Klann L;Salzman JG;Wewerka SS;Yannopoulos D;Lurie KG;O'Neil BJ;Holcomb RG;Aufderheide TP
• 通讯作者: Aufderheide TP

From laboratory science to six emergency medical services systems: New understanding of the physiology of cardiopulmonary resuscitation increases survival rates after cardiac arrest.

• DOI: 10.1097/ccm.0b013e31818a7e56
• 发表时间: 2008-11
• 期刊: Critical care medicine
• 影响因子: 8.8
• 作者: Aufderheide TP;Alexander C;Lick C;Myers B;Romig L;Vartanian L;Stothert J;McKnite S;Matsuura T;Yannopoulos D;Lurie K
• 通讯作者: Lurie K

Standard cardiopulmonary resuscitation versus active compression-decompression cardiopulmonary resuscitation with augmentation of negative intrathoracic pressure for out-of-hospital cardiac arrest: a randomised trial.

标准的心肺复苏与主动压缩 - 压缩 - 肺肺复苏，增加院外心脏骤停的负面压力：一项随机试验。

• DOI: 10.1016/s0140-6736(10)62103-4
• 发表时间: 2011-01-22
• 期刊: LANCET
• 影响因子: 168.9
• 作者: Aufderheide, Tom P.;Frascone, Ralph J.;Wayne, Marvin A.;Mahoney, Brian D.;Swor, Robert A.;Domeier, Robert M.;Olinger, Michael L.;Holcomb, Richard G.;Tupper, David E.;Yannopoulos, Demetris;Lurie, Keith G.
• 通讯作者: Lurie, Keith G.

Regional variation in out-of-hospital cardiac arrest incidence and outcome.

• DOI: 10.1001/jama.300.12.1423
• 发表时间: 2008-09-24
• 期刊: JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION
• 影响因子: 120.7
• 作者: Nichol, Graham;Thomas, Elizabeth;Callaway, Clifton W.;Hedges, Jerris;Powell, Judy L.;Aufderheide, Tom P.;Rea, Tom;Lowe, Robert;Brown, Todd;Dreyer, John;Davis, Dan;Idris, Ahamed;Stiell, Ian
• 通讯作者: Stiell, Ian