Clinical Evaluation of a Rebreathing Adsorber Mask to Facilitate Recovery from Vo

促进 Vo 恢复的再呼吸吸附面罩的临床评估

• 批准号: 7477626
• 负责人: Joseph A Orr
• 金额: $ 9.58万
• 依托单位: AXON MEDICAL, INC.
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-04-15 至 2009-10-14
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7477626
• 关键词: Admission activity; Adverse event; Anesthesia procedures; Anesthetic Gases; Anesthetics; Apnea; Carbon Dioxide; Cardiac; Caring; Charcoal; Clinical; Clinical Trials; Complication; Delirium; Devices; Environmental Pollution; Event; Excision; Exhalation; Gases; General anesthetic drugs; Hour; Hyperalgesia; Hypoxia; Impaired cognition; Incidence; Intake; Intensive Care Units; Intervention; Lung; Masks; Measures; Monitor; Nausea and Vomiting; Normalcy; Numbers; Obstruction; Operating Rooms; Operative Surgical Procedures; Oral; Oxygen; Patient Transfer; Patients; Phase; Postoperative Period; Procedures; Public Health; Rate; Recovery; Reflex action; Risk; Severities; Speed; Testing; Time; United States; Urination; Well in self; airway obstruction; awake; cognitive function; cost; design; desire; hemodynamics; prevent; prototype; research clinical testing; respiratory; vapor

DESCRIPTION (provided by applicant): After surgery patients are transferred to a post anesthesia care unit to fully recover from anesthesia. There is a much higher chance of an adverse clinical event occurring during this recovery time (24%) than in the operating room because patients are not as closely monitored. Airway obstruction is the most frequent complication. Patients with a critical respiratory event stay longer in the care unit, have higher rates of unanticipated admission to an intensive care unit and are more likely to have cardiac problems. We propose to develop and test a charcoal filled rebreathing mask that accelerates the rate of removal of anesthetic vapors and shortens anesthesia recovery time. Patients will more quickly regain normal cognitive function, homodynamic normalcy and reflexes to allow for airway protection from secretions and obstruction. They will more quickly gain a sense of well being resulting in earlier discharge from the post anesthesia care unit. We will test a prototype device with a lung/gas exchange simulator and conduct a clinical trial with 44 patients, measuring their rate of recovery and the incidence of critical events during the first 24 hours after surgery. If successful, the charcoal filled rebreathing mask has the potential to shorten the patients stay in the post anesthesia care unit by 20 min and reduce the risk of a critical event occurring by 60%. PUBLIC HEALTH RELEVANCE: Use of the rebreathing mask to speed recovery after anesthesia could potentially reduce the overall cost of each of the 20 million general anesthetic procedures performed in the United States each year. Reducing the recover time by 20 min might decrease the cost of a patient's stay in the PACU by $110 and reduce the risk of post anesthesia critical events by 60%.

描述（由申请人提供）：手术后患者被转移到麻醉后护理病房，以完全从麻醉中恢复。由于没有对患者进行密切监测，在此恢复期间发生不良临床事件的几率（24%）比在手术室中高得多。气道阻塞是最常见的并发症。患有严重呼吸事件的患者在护理病房停留的时间更长，意外进入重症监护病房的比例更高，并且更有可能出现心脏问题。我们建议开发和测试一种木炭填充的再呼吸面罩，以加快麻醉蒸汽的去除速度，缩短麻醉恢复时间。患者将更快地恢复正常的认知功能、同动功能和反射，从而保护气道免受分泌物和阻塞的影响。他们会更快地获得一种幸福感，从而更早地从麻醉后护理病房出院。我们将测试一个带有肺/气体交换模拟器的原型设备，并对44名患者进行临床试验，测量他们在手术后最初24小时内的恢复率和关键事件的发生率。如果成功，充满木炭的再呼吸面罩有可能缩短患者在麻醉后护理病房的停留时间20分钟，并将发生严重事件的风险降低60%。公共卫生相关性：使用再呼吸面罩加速麻醉后的恢复，可能会降低美国每年进行的2000万次全身麻醉手术的总成本。将恢复时间缩短20分钟可能会使患者在PACU的住院费用减少110美元，并将麻醉后危急事件的风险降低60%。