The Feasibility of Implementing Light Sedation after Initiation of Mechanical Ventilation in the Emergency Department: the ED-SED Pilot Trial

急诊科机械通气后实施轻度镇静的可行性：ED-SED 试点试验

• 批准号: 10353378
• 负责人: Brian M Fuller
• 金额: $ 11.54万
• 依托单位: WASHINGTON UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-02-01 至 2023-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10353378
• 关键词: Accident and Emergency department; Acute respiratory failure; Address; Adult; Adverse event; Agitation; American; Attention; Cessation of life; Clinical; Clinical Medicine; Clinical Practice Guideline; Clinical Research; Clinical Trials; Cluster randomized trial; Coma; Consequentialism; Critical Care; Critical Illness; Data; Emergency Department patient; Emergency Nursing; Exposure to; Functional disorder; Future; Goals; Health Benefit; Hour; Impaired cognition; Incidence; Influentials; Intensive Care Units; Intervention; Intubation; Length of Stay; Light; Literature; Measurement; Mechanical ventilation; Monitor; Nurses; Nursing Assessment; Outcome; Patient-Focused Outcomes; Patients; Perception; Pharmaceutical Preparations; Physicians; Pilot Projects; Play; Protocols documentation; Public Health; Quality of life; Rehabilitation therapy; Research; Respiratory Failure; Role; Safety; Sedation procedure; Site; Surveys; Survivors; Testing; Time; Training; Unconscious State; United States; Ventilator; base; clinical practice; cohort; college; disability; experience; implementation barriers; implementation study; improved; improved outcome; member; mortality; organizational structure; pilot trial; programs; prospective; psychologic; recruit; routine care; sedative; success

PROJECT SUMMARY/ABSTRACT Annually in the United States, approximately 250,000 patients require mechanical ventilation in the emergency department (ED) and over 30% will die. The majority of survivors experience crippling long-term disability including cognitive decline, psychological dysfunction, and lengthy rehabilitation. Recent data suggest that exposure to deep sedation (i.e. unconsciousness or coma due to excessive sedative administration) after the initiation of mechanical ventilation is associated with greater mechanical ventilation duration, lengths of stay, and mortality. Deep sedation is extremely common while mechanical ventilation is provided in the ED; however, no clinical study has tested if targeting light sedation in the immediate post-intubation period in the ED improves outcome. Our hypothesis is that targeting a light sedation depth after the initiation of mechanical ventilation in the ED is associated with improved clinical outcomes, including a reduced duration of mechanical ventilation. To test this hypothesis, our team will capitalize on our extensive experience with initiating clinical studies in the ED and continuing these intervention protocols into the intensive care unit (ICU), and will propose a future multi-center, stepped-wedge, cluster randomized trial. The scientific literature and our preliminary data provide the rationale for conducting a large-scale clinical trial. However, several gaps currently prohibit proceeding. The feasibility of implementing an ED-based goal- oriented sedation protocol is unknown in terms of: 1) recruitment; 2) efficacy in achieving target sedation; 3) reliability of sedation measurements during routine care in the ED; 4) adverse events; and 5) barriers to implementation. Therefore this proposal is for a multicenter (n= 3) prospective before-and-after protocol implementation study examining the feasibility of a protocol which targets light sedation after intubation among 344 mechanically ventilated adult ED patients. These data will be supplemented with a qualitative assessment of barriers to implementation (survey of nurses and physicians). Through the aims of this preparatory pilot study, we will acquire the necessary and sufficient data, and demonstrate a clear organizational structure, critical to complete the full-scale clinical trial. This project has the potential to completely change the clinical practice of early sedation management, and improve survival and quality of life in patients suffering from acute respiratory failure. Given the magnitude of death and disability experienced by mechanically ventilated ED patients, even modest improvements would provide a major public health benefit.

项目总结/文摘

项目成果

A study protocol for a multicentre, prospective, before-and-after trial evaluating the feasibility of implementing targeted SEDation after initiation of mechanical ventilation in the emergency department (The ED-SED Pilot Trial).

一项针对多中心，前瞻性的，前后试验的研究方案，评估了急诊科开始机械通气后实施靶向镇静的可行性（ED-SED PILOT试验）。

• DOI: 10.1136/bmjopen-2020-041987
• 发表时间: 2020-12-16
• 期刊: BMJ open
• 影响因子: 2.9
• 作者: Fuller BM;Roberts BW;Mohr NM;Pappal RD;Stephens RJ;Yan Y;Carpenter C;Kollef MH;Avidan MS
• 通讯作者: Avidan MS

Awareness With Paralysis Among Critically Ill Emergency Department Patients: A Prospective Cohort Study.

• DOI: 10.1097/ccm.0000000000005626
• 发表时间: 2022-10-01
• 期刊: Critical care medicine
• 影响因子: 8.8

The AIR-SED Study: A Multicenter Cohort Study of SEDation Practices, Deep Sedation, and Coma Among Mechanically Ventilated AIR Transport Patients.

• DOI: 10.1097/cce.0000000000000597
• 发表时间: 2021-12
• 期刊: Critical care explorations
• 作者: Moy HP;Olvera D;Nayman BD;Pappal RD;Hayes JM;Mohr NM;Kollef MH;Palmer CM;Ablordeppey E;Faine B;Roberts BW;Fuller BM
• 通讯作者: Fuller BM

The Feasibility of Implementing Targeted SEDation in Mechanically Ventilated Emergency Department Patients: The ED-SED Pilot Trial.

• DOI: 10.1097/ccm.0000000000005558
• 发表时间: 2022-08-01
• 期刊: Critical care medicine
• 影响因子: 8.8

A Dual-Center Cohort Study on The Association Between Early Deep Sedation and Clinical Outcomes in Mechanically Ventilated Patients During the COVID-19 Pandemic: the COVID-SED Study.

关于 COVID-19 大流行期间机械通气患者早期深度镇静与临床结果之间关系的双中心队列研究：COVID-SED 研究。

• DOI: 10.21203/rs.3.rs-1389892/v1
• 发表时间: 2022
• 期刊: Research square
• 作者: Stephens,RobertJ;Evans,ErinM;Pajor,MichaelJ;Pappal,RyanD;Egan,HaleyM;Wei,Max;Hayes,Hunter;Morris,JasonA;Becker,Nicholas;Roberts,BrianW;Kollef,MarinH;Mohr,NicholasM;Fuller,BrianM
• 通讯作者: Fuller,BrianM