觉醒-呼吸协调、谵妄监测/管理和早期活动 (ABCDE) 协议 (ABCDE)
2023年9月13日 更新者:University of Nebraska
拟议的罗伯特伍德约翰逊基金会跨学科护理质量研究计划 (RWJF INQRI) 项目的主要目标是实施、分析和传播以证据为基础、护士主导、跨专业、多组成部分的计划,重点是改善护理和重症成人的结果。
研究概览
详细说明
我们面临着一个深刻而新出现的公共卫生问题,其形式是青年和老年重症监护病房 (ICU) 幸存者的急性和慢性脑功能障碍,这正在改变社会面貌。
整整三分之二的 ICU 患者出现精神错乱,这与住院时间延长、全球数十亿美元的成本以及 6 个月时死亡率增加 3 倍有关。
超过一半的 ICU 幸存者患有功能衰弱的痴呆样疾病,这似乎与谵妄持续时间有关。
对一个人生活的影响往往是毁灭性的。
拟议的 INQRI 项目的主要目标是实施、分析和传播以证据为基础、护士主导、跨专业、多组成部分的计划,重点是改善危重病人的护理和结果。
该研究将侧重于应用觉醒-呼吸协调、精神错乱监测/管理和早期活动 (ABCDE),这是范德比尔特大学开发的精神错乱筛查、预防和治疗计划。
ABCDE 方法分析并合并了与 ICU 中的谵妄、镇痛和镇静 (DAS) 管理相关的最佳可用证据,并将之前 DAS 临床试验中使用的药物和非药物干预措施调整为一个程序,可以在更短的时间内付诸实践。以研究为中心”的重症监护病房。
具体而言,该研究旨在 (1) 在目前不进行常规 ICU 谵妄筛查的医疗中心实施 ABCDE 计划,并确定采用该计划的促进因素和障碍; (2) 测试 ABCDE 计划对患者结果、护理质量结果和系统结果的影响; (3) 评估 ABCDE 实施的有效、可持续和有利于传播到其他环境的程度。
研究类型
观察性的
注册 (实际的)
200
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
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Nebraska
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Omaha、Nebraska、美国、68198
- University of Nebraska Medical Center
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
19年 及以上 (成人、年长者)
接受健康志愿者
不
取样方法
非概率样本
研究人群
重症监护服务
描述
纳入标准:
- 大于或等于 19 岁
- 内布拉斯加大学医学中心和内布拉斯加医学中心的患者
- 被学术医学或创伤重症监护服务录取
排除标准:
- 无法在进入 ICU 后 48 小时内提供参与同意的合法授权代表
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 观测模型:队列
- 时间观点:预期
队列和干预
团体/队列 |
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重症监护病房患者
成年患者入住内布拉斯加大学医学中心或内布拉斯加医学中心创伤重症监护服务中心。
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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无呼吸机天数 (VFD)
大体时间:基线时无呼吸机天数变为 9 个月
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主要结果将是 3 个月的无呼吸机天数基线期与干预后 9 个月的比较。
将进行两项中期分析。
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基线时无呼吸机天数变为 9 个月
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Michele Balas, PhD、University of Nebraska
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
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- Thomason JW, Shintani A, Peterson JF, Pun BT, Jackson JC, Ely EW. Intensive care unit delirium is an independent predictor of longer hospital stay: a prospective analysis of 261 non-ventilated patients. Crit Care. 2005 Aug;9(4):R375-81. doi: 10.1186/cc3729. Epub 2005 Jun 1.
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- Pandharipande P, Cotton BA, Shintani A, Thompson J, Pun BT, Morris JA Jr, Dittus R, Ely EW. Prevalence and risk factors for development of delirium in surgical and trauma intensive care unit patients. J Trauma. 2008 Jul;65(1):34-41. doi: 10.1097/TA.0b013e31814b2c4d.
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- Girard TD, Pandharipande PP, Ely EW. Delirium in the intensive care unit. Crit Care. 2008;12 Suppl 3(Suppl 3):S3. doi: 10.1186/cc6149. Epub 2008 May 14.
- Dubois MJ, Bergeron N, Dumont M, Dial S, Skrobik Y. Delirium in an intensive care unit: a study of risk factors. Intensive Care Med. 2001 Aug;27(8):1297-304. doi: 10.1007/s001340101017.
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- Knaus WA, Wagner DP, Draper EA, Zimmerman JE, Bergner M, Bastos PG, Sirio CA, Murphy DJ, Lotring T, Damiano A, et al. The APACHE III prognostic system. Risk prediction of hospital mortality for critically ill hospitalized adults. Chest. 1991 Dec;100(6):1619-36. doi: 10.1378/chest.100.6.1619.
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- Ely EW, Baker AM, Dunagan DP, Burke HL, Smith AC, Kelly PT, Johnson MM, Browder RW, Bowton DL, Haponik EF. Effect on the duration of mechanical ventilation of identifying patients capable of breathing spontaneously. N Engl J Med. 1996 Dec 19;335(25):1864-9. doi: 10.1056/NEJM199612193352502.
- Girard TD, Kress JP, Fuchs BD, Thomason JW, Schweickert WD, Pun BT, Taichman DB, Dunn JG, Pohlman AS, Kinniry PA, Jackson JC, Canonico AE, Light RW, Shintani AK, Thompson JL, Gordon SM, Hall JB, Dittus RS, Bernard GR, Ely EW. Efficacy and safety of a paired sedation and ventilator weaning protocol for mechanically ventilated patients in intensive care (Awakening and Breathing Controlled trial): a randomised controlled trial. Lancet. 2008 Jan 12;371(9607):126-34. doi: 10.1016/S0140-6736(08)60105-1.
- Milbrandt EB, Deppen S, Harrison PL, Shintani AK, Speroff T, Stiles RA, Truman B, Bernard GR, Dittus RS, Ely EW. Costs associated with delirium in mechanically ventilated patients. Crit Care Med. 2004 Apr;32(4):955-62. doi: 10.1097/01.ccm.0000119429.16055.92.
- Sleiman I, Rozzini R, Trabucchi M. Delirium in older patients in intensive care units. Arch Intern Med. 2008 Jun 9;168(11):1229. doi: 10.1001/archinte.168.11.1229-a. No abstract available.
- Micek ST, Anand NJ, Laible BR, Shannon WD, Kollef MH. Delirium as detected by the CAM-ICU predicts restraint use among mechanically ventilated medical patients. Crit Care Med. 2005 Jun;33(6):1260-5. doi: 10.1097/01.ccm.0000164540.58515.bf.
- Balas MC, Happ MB, Yang W, Chelluri L, Richmond T. Outcomes Associated With Delirium in Older Patients in Surgical ICUs. Chest. 2009 Jan;135(1):18-25. doi: 10.1378/chest.08-1456. Epub 2008 Nov 18.
- Lin SM, Liu CY, Wang CH, Lin HC, Huang CD, Huang PY, Fang YF, Shieh MH, Kuo HP. The impact of delirium on the survival of mechanically ventilated patients. Crit Care Med. 2004 Nov;32(11):2254-9. doi: 10.1097/01.ccm.0000145587.16421.bb.
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- Happ MB, Tate J, Garret K. Nursing counts. Focus on: nonspeaking older adults in the ICU: communication will require special strategies. American Journal of Nursing 106(5):29, 2006.
- Happ MB. Interpretation of nonvocal behavior and the meaning of voicelessness in critical care. Soc Sci Med. 2000 May;50(9):1247-55. doi: 10.1016/s0277-9536(99)00367-6.
- Happ MB. Communicating with mechanically ventilated patients: state of the science. AACN Clin Issues. 2001 May;12(2):247-58. doi: 10.1097/00044067-200105000-00008.
- Inouye SK, Viscoli CM, Horwitz RI, Hurst LD, Tinetti ME. A predictive model for delirium in hospitalized elderly medical patients based on admission characteristics. Ann Intern Med. 1993 Sep 15;119(6):474-81. doi: 10.7326/0003-4819-119-6-199309150-00005.
- Patel RP, Gambrell M, Speroff T, Scott TA, Pun BT, Okahashi J, Strength C, Pandharipande P, Girard TD, Burgess H, Dittus RS, Bernard GR, Ely EW. Delirium and sedation in the intensive care unit: survey of behaviors and attitudes of 1384 healthcare professionals. Crit Care Med. 2009 Mar;37(3):825-32. doi: 10.1097/CCM.0b013e31819b8608.
- Pun BT, Ely EW. The importance of diagnosing and managing ICU delirium. Chest. 2007 Aug;132(2):624-36. doi: 10.1378/chest.06-1795.
- Brook AD, Ahrens TS, Schaiff R, Prentice D, Sherman G, Shannon W, Kollef MH. Effect of a nursing-implemented sedation protocol on the duration of mechanical ventilation. Crit Care Med. 1999 Dec;27(12):2609-15. doi: 10.1097/00003246-199912000-00001.
- Richman PS, Baram D, Varela M, Glass PS. Sedation during mechanical ventilation: a trial of benzodiazepine and opiate in combination. Crit Care Med. 2006 May;34(5):1395-401. doi: 10.1097/01.CCM.0000215454.50964.F8.
- Chanques G, Jaber S, Barbotte E, Violet S, Sebbane M, Perrigault PF, Mann C, Lefrant JY, Eledjam JJ. Impact of systematic evaluation of pain and agitation in an intensive care unit. Crit Care Med. 2006 Jun;34(6):1691-9. doi: 10.1097/01.CCM.0000218416.62457.56.
- Mascia MF, Koch M, Medicis JJ. Pharmacoeconomic impact of rational use guidelines on the provision of analgesia, sedation, and neuromuscular blockade in critical care. Crit Care Med. 2000 Jul;28(7):2300-6. doi: 10.1097/00003246-200007000-00019.
- Arias-Rivera S, Sanchez-Sanchez Mdel M, Santos-Diaz R, Gallardo-Murillo J, Sanchez-Izquierdo R, Frutos-Vivar F, Ferguson ND, Esteban A. Effect of a nursing-implemented sedation protocol on weaning outcome. Crit Care Med. 2008 Jul;36(7):2054-60. doi: 10.1097/CCM.0b013e31817bfd60.
- Quenot JP, Ladoire S, Devoucoux F, Doise JM, Cailliod R, Cunin N, Aube H, Blettery B, Charles PE. Effect of a nurse-implemented sedation protocol on the incidence of ventilator-associated pneumonia. Crit Care Med. 2007 Sep;35(9):2031-6. doi: 10.1097/01.ccm.0000282733.83089.4d.
- Kress JP, Pohlman AS, O'Connor MF, Hall JB. Daily interruption of sedative infusions in critically ill patients undergoing mechanical ventilation. N Engl J Med. 2000 May 18;342(20):1471-7. doi: 10.1056/NEJM200005183422002.
- Schweickert WD, Gehlbach BK, Pohlman AS, Hall JB, Kress JP. Daily interruption of sedative infusions and complications of critical illness in mechanically ventilated patients. Crit Care Med. 2004 Jun;32(6):1272-6. doi: 10.1097/01.ccm.0000127263.54807.79.
- Kress JP, Gehlbach B, Lacy M, Pliskin N, Pohlman AS, Hall JB. The long-term psychological effects of daily sedative interruption on critically ill patients. Am J Respir Crit Care Med. 2003 Dec 15;168(12):1457-61. doi: 10.1164/rccm.200303-455OC. Epub 2003 Oct 2.
- King MS, Render ML, Ely EW, Watson PL. Liberation and animation: strategies to minimize brain dysfunction in critically ill patients. Semin Respir Crit Care Med. 2010 Feb;31(1):87-96. doi: 10.1055/s-0029-1246284. Epub 2010 Jan 25.
- Jacobi J, Fraser GL, Coursin DB, Riker RR, Fontaine D, Wittbrodt ET, Chalfin DB, Masica MF, Bjerke HS, Coplin WM, Crippen DW, Fuchs BD, Kelleher RM, Marik PE, Nasraway SA Jr, Murray MJ, Peruzzi WT, Lumb PD; Task Force of the American College of Critical Care Medicine (ACCM) of the Society of Critical Care Medicine (SCCM), American Society of Health-System Pharmacists (ASHP), American College of Chest Physicians. Clinical practice guidelines for the sustained use of sedatives and analgesics in the critically ill adult. Crit Care Med. 2002 Jan;30(1):119-41. doi: 10.1097/00003246-200201000-00020. No abstract available. Erratum In: Crit Care Med 2002 Mar;30(3):726.
- Kress JP, Pohlman AS, Hall JB. Sedation and analgesia in the intensive care unit. Am J Respir Crit Care Med. 2002 Oct 15;166(8):1024-8. doi: 10.1164/rccm.200204-270CC. No abstract available.
- Sessler CN, Pedram S. Protocolized and target-based sedation and analgesia in the ICU. Crit Care Clin. 2009 Jul;25(3):489-513, viii. doi: 10.1016/j.ccc.2009.03.001.
- Franck LS, Naughton I, Winter I. Opioid and benzodiazepine withdrawal symptoms in paediatric intensive care patients. Intensive Crit Care Nurs. 2004 Dec;20(6):344-51. doi: 10.1016/j.iccn.2004.07.008.
- Shintani AK, Girard TD, Ely EW. Immortal time bias in critical care. Crit Care Med. 2010 Apr;38(4):1229. doi: 10.1097/CCM.0b013e3181ce473d. No abstract available.
- Robinson BR, Mueller EW, Henson K, Branson RD, Barsoum S, Tsuei BJ. An analgesia-delirium-sedation protocol for critically ill trauma patients reduces ventilator days and hospital length of stay. J Trauma. 2008 Sep;65(3):517-26. doi: 10.1097/TA.0b013e318181b8f6.
- Hooper MH, Girard TD. Sedation and weaning from mechanical ventilation: linking spontaneous awakening trials and spontaneous breathing trials to improve patient outcomes. Crit Care Clin. 2009 Jul;25(3):515-25, viii. doi: 10.1016/j.ccc.2009.04.002.
- Esteban A, Alia I, Gordo F, Fernandez R, Solsona JF, Vallverdu I, Macias S, Allegue JM, Blanco J, Carriedo D, Leon M, de la Cal MA, Taboada F, Gonzalez de Velasco J, Palazon E, Carrizosa F, Tomas R, Suarez J, Goldwasser RS. Extubation outcome after spontaneous breathing trials with T-tube or pressure support ventilation. The Spanish Lung Failure Collaborative Group. Am J Respir Crit Care Med. 1997 Aug;156(2 Pt 1):459-65. doi: 10.1164/ajrccm.156.2.9610109. Erratum In: Am J Respir Crit Care Med 1997 Dec;156(6):2028.
- Jackson JC, Girard TD, Gordon SM, Thompson JL, Shintani AK, Thomason JW, Pun BT, Canonico AE, Dunn JG, Bernard GR, Dittus RS, Ely EW. Long-term cognitive and psychological outcomes in the awakening and breathing controlled trial. Am J Respir Crit Care Med. 2010 Jul 15;182(2):183-91. doi: 10.1164/rccm.200903-0442OC. Epub 2010 Mar 18.
- Vasilevskis EE, Ely EW, Speroff T, Pun BT, Boehm L, Dittus RS. Reducing iatrogenic risks: ICU-acquired delirium and weakness--crossing the quality chasm. Chest. 2010 Nov;138(5):1224-33. doi: 10.1378/chest.10-0466.
- Kahn JM, Brake H, Steinberg KP. Intensivist physician staffing and the process of care in academic medical centres. Qual Saf Health Care. 2007 Oct;16(5):329-33. doi: 10.1136/qshc.2007.022376.
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- Wall RJ, Ely EW, Elasy TA, Dittus RS, Foss J, Wilkerson KS, Speroff T. Using real time process measurements to reduce catheter related bloodstream infections in the intensive care unit. Qual Saf Health Care. 2005 Aug;14(4):295-302. doi: 10.1136/qshc.2004.013516.
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- Pun BT, Gordon SM, Peterson JF, Shintani AK, Jackson JC, Foss J, Harding SD, Bernard GR, Dittus RS, Ely EW. Large-scale implementation of sedation and delirium monitoring in the intensive care unit: a report from two medical centers. Crit Care Med. 2005 Jun;33(6):1199-205. doi: 10.1097/01.ccm.0000166867.78320.ac.
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- Moore DE Jr, Green JS, Gallis HA. Achieving desired results and improved outcomes: integrating planning and assessment throughout learning activities. J Contin Educ Health Prof. 2009 Winter;29(1):1-15. doi: 10.1002/chp.20001.
- Harle MT, Dela RF, Veloso G, Rock J, Faulkner J, Cohen MZ. The experiences of Filipino American patients with cancer. Oncol Nurs Forum. 2007 Nov;34(6):1170-5. doi: 10.1188/07.ONF.1170-1175.
- Frazier L, Calvin AO, Mudd GT, Cohen MZ. Understanding of genetics among older adults. J Nurs Scholarsh. 2006;38(2):126-32. doi: 10.1111/j.1547-5069.2006.00089.x.
- Calvin AO, Frazier L, Cohen MZ. Examining older adults' perceptions of health care providers: identifying important aspects of older adults' relationships with physicians and nurses. J Gerontol Nurs. 2007 May;33(5):6-12. doi: 10.3928/00989134-20070501-03.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2010年12月29日
初级完成 (实际的)
2012年4月1日
研究完成 (实际的)
2013年6月1日
研究注册日期
首次提交
2011年8月2日
首先提交符合 QC 标准的
2011年8月8日
首次发布 (估计的)
2011年8月9日
研究记录更新
最后更新发布 (实际的)
2023年9月15日
上次提交的符合 QC 标准的更新
2023年9月13日
最后验证
2023年9月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.