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

测试 ICU 通气患者自控镇静的可行性

基本信息

批准号：
8240351
负责人：
CRAIG R WEINERT
金额：
$ 17.55万
依托单位：
UNIVERSITY OF MINNESOTA
依托单位国家：
美国
项目类别：
财政年份：
2012
资助国家：
美国
起止时间：
2012-02-15 至 2014-01-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8240351
关键词：
Absence of pain sensation Acute Address Adherence Admission activity Adopted Adult Adverse effects Adverse event Algorithms Ambulatory Surgical Procedures Anxiety Area Belief Breathing Caregivers Caring Chronic Disease Client satisfaction Clinical Clinical Trials Confusion Consent Critical Illness Data Delirium Devices Dexmedetomidine Diagnostic Procedure Disease Distress Dose Drug Exposure Enrollment Fright Funding Future Goals Hour Infusion Pumps Infusion procedures Inpatients Intensive Care Units Intervention Intravenous Intubation Length Life Measures Mechanical Ventilators Mechanical ventilation Mental Health Methodology Methods Modality Nurses Opioid Outcome Pain Pain management Patient Care Patient-Controlled Analgesia Patients Pharmaceutical Preparations Pilot Projects Postoperative Period Process Protocols documentation Proxy Pump Quality of life Randomized Randomized Controlled Trials Recruitment Activity Research Research Personnel Respiratory Failure Safety Sampling Science Sedation procedure Self Assessment Self Management Stress Symptoms Technology Testing Time Translating United States National Institutes of Health Ventilator Visual Weaning Work adverse outcome alertness analog base clinical practice clinically relevant design experience improved innovation mental state new technology pilot trial protocol violation randomized trial sedative symptom management treatment as usual trial comparing

项目摘要

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.

描述（由申请人提供）：机械通气（MV）是重症监护室（ICU）最常用的生命支持方式。为了减少焦虑、压力并提高对 MV 的耐受性，护士经常根据主观观察给患者服用各种镇静药物。虽然有时需要使用镇静剂，但它可能会产生严重的副作用，包括脱机延迟、精神状态改变、MV 延长和 ICU 停留时间延长。需要安全但能减轻 ICU 患者所经历的痛苦症状的替代策略。患者自控镇静 (PCS) 是一种需要在 ICU 中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) 已广泛用于术后患者的护理，并且已证明比护士提供的镇痛具有更好的疼痛管理和患者满意度。虽然 PCS 对通气 ICU 患者有很大希望，但尚未对其进行超过 24 小时的评估，因此尚不清楚 PCS 对于通气患者在大部分通气支持期间用于症状自我管理是否安全可行。该试点研究将：1) 在随机试点试验中确定受试者招募和方案遵守的可行性，该试验将使用右美托咪定的 PCS 与机械通气患者的常规镇静实践进行比较，2) 评估和完善研究方案，以：a) 提高完成率对于受试者自我评估，例如焦虑和谵妄量表，b) 可靠地确定受试者何时由于虚弱、混乱或严重疾病而无法自我管理镇静； c) 制定在未来 RCT 中暂停 PCS 治疗的规则，以及 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、焦虑水平和谵妄发生率，b)与药物、泵或两者相关的不良事件发生率和方案违规情况； c) 机械通气和 ICU 停留时间。将从中西部城市的两个 ICU 中招募 40 名机械通气成年患者作为样本。受试者将被分配到 PCS 或常规护理，由患者护理护士进行镇静治疗。每日评估包括视觉模拟量表——焦虑、警觉性和谵妄存在（CAM-ICU）。这项研究的长期目标是通过直接鼓励患者自我管理与通气支持相关的常见痛苦症状，对每年经历 MV 的数百万 ICU 患者的重要临床结果和生活质量产生积极影响。该项目涉及 NINR 的测试策略机会领域，以改善疾病轨迹上的症状管理（例如，需要 MV 的危重疾病）。拟议的研究采用了让患者直接参与症状管理的创新方法。这项研究将获得有关 PCS 安全性和可行性的重要初步数据，为未来直接比较 PCS 与护士服用的镇静药物对显着患者预后的随机试验提供信息。公共卫生相关性：项目叙述每天在美国 ICU 接受护理的 55,000 名成年人中，大多数需要机械通气支持来治疗各种原因引起的呼吸衰竭。使用镇静剂是 ICU 的常见做法，用于治疗插管和机械通气引起的焦虑和痛苦。证明患者自控镇静在该患者群体中的安全性和可行性，有可能对美国每年数千名机械通气 ICU 患者的治疗结果产生积极影响。