Testing the feasibility of patient-controlled sedation in ventilated ICU patients

描述（由申请人提供）：机械通气（MV）是重症监护病房（icu）中最常用的生命支持方式。为了减少焦虑、压力和促进对MV的耐受性，护士经常根据主观观察给病人使用各种镇静药物。虽然有时需要镇静，但它可能有严重的副作用，包括延迟脱机、精神状态改变、延长MV和延长ICU住院时间。需要替代策略，既安全又能减轻ICU患者的痛苦症状。患者控制镇静（PCS）是一种值得在ICU对通气患者进行测试的策略。自20世纪80年代以来，患者自控镇痛（PCA）已广泛应用于术后患者的护理，并证明了优于护士镇痛的疼痛管理和患者满意度。虽然PCS在通气ICU患者中具有很大的前景，但尚未对其进行超过24小时的评估，因此尚不清楚在通气支持的很大一部分中，PCS对于通气患者用于症状自我管理是否安全可行。该试点研究将：1)在随机试点试验中建立受试者招募和方案依从性的可行性，将使用右美托咪定的PCS与机械通气患者的常规镇静做法进行比较；2)评估和完善研究方案，以：a)提高受试者自我评估的完成率，如焦虑和谵谵症量表；b)可靠地确定受试者何时因虚弱、意识不清或严重疾病而无法自我管理镇静；c)在未来的随机对照试验中制定暂停PCS治疗的规则，3)估计关键变量的效应大小，为未来随机试验的设计提供信息，以比较：a)组间镇静剂暴露、焦虑水平和谵妄的发生，b)与药物、泵或两者相关的不良事件发生率和协议违反；c)机械通气时间和ICU住院时间。将从中西部城市的两个icu中招募40名机械通气成人患者。受试者将被分配到PCS或常规护理，镇静治疗由患者护理护士管理。日常评估包括视觉模拟量表-焦虑，警觉性和谵妄存在（CAM-ICU）。本研究的长期目标是通过直接鼓励患者自我管理与呼吸支持相关的常见痛苦症状，积极影响每年经历MV的数百万ICU患者的重要临床结果和生活质量。该项目涉及国家癌症研究所的机会领域，即测试战略，以改善对疾病轨迹（例如，需要MV的危重疾病）的症状管理。提出的研究采用创新的方法，让患者直接参与症状管理。该研究将获得PCS的安全性和可行性的重要初步数据，为未来的随机试验提供信息，直接比较PCS与护士给药的镇静药物对患者预后的影响。

DESCRIPTION (provided by applicant): Mechanical ventilation (MV) is the most frequently used life-support modality in intensive care units (ICUs). To reduce anxiety, stress and promote tolerance of MV, nurses frequently administer a variety of sedative medications to their patients based on subjective observations. While sedation is indicated at times, it can have serious side effects, including delayed weaning, mental status changes, prolonged MV, and extended ICU stay. Alternative strategies are needed that are safe yet alleviate the distressful symptoms experienced by ICU patients. Patient-controlled sedation (PCS) is a strategy that warrants testing in the ICU with ventilated patients. Patient-controlled analgesia (PCA) has been widely used in care of post-operative patients since the 1980's and has demonstrated superior pain management and patient satisfaction over nurse-delivered analgesia. While PCS holds great promise with ventilated ICU patients, it has not been evaluated for longer than 24 hours, thus it is not known if PCS is safe and feasible for ventilated patients to use for symptom self- management during a significant portion of ventilatory support. This pilot study will: 1) Establish the feasibility of subject recruitment and protocol adherence in a randomized pilot trial that compares PCS using dexmedetomidine to usual sedation practice in mechanically ventilated patients, 2) Evaluate and refine the study protocol to: a) improve completion rates for subject self-assessments such as anxiety and delirium scales, b) reliably determine when subjects are unable to self-manage their sedation due to weakness, confusion or severe illness; c) create rules for suspending PCS therapy in a future RCT, and 3) Estimate effect sizes on key variables to inform the design of a future randomized trial to compare: a) sedative exposure, anxiety levels, and delirium occurrence between groups, b) adverse event rates and protocol violations related to the drug, pump or both; and c) duration of mechanical ventilation and ICU stay. A sample of 40 mechanically ventilated adult patients will be recruited from two ICUs in the urban Midwest. Subjects will be allocated to PCS or usual care whereby sedative therapy is administered by patient-care nurses. Daily assessments include visual analog scale-anxiety, alertness and delirium presence (CAM-ICU). Long-term objectives of this research are to positively impact important clinical outcomes and quality of life for the millions of ICU patients who experience MV each year by directly encouraging patient self-management of common distressful symptoms associated with ventilatory support. This project addresses NINR's area of opportunity for testing strategies to improve management of symptoms over disease trajectories (e.g., critical illness requiring MV). The proposed study takes the innovative approach of involving patients directly with symptom management. This study will obtain important preliminary data on the safety and feasibility of PCS to inform a future randomized trial directly comparing PCS with nurse-administered sedative medications on salient patient outcomes. PUBLIC HEALTH RELEVANCE: Project Narrative A majority of the 55,000 adults who receive care each day in U.S. ICUs require mechanical ventilatory support to treat respiratory failure from a variety of causes. Administration of sedative agents is a common practice in ICUs to treat anxiety and distress that arise from intubation and mechanical ventilation. Demonstrating the safety and feasibility of patient-controlled sedation in this patient population has the potential to positively impact outcomes for thousands of mechanically ventilated ICU patients each year in the U.S.