Reducing Sedative Exposure in Ventilated ICU Patients

减少 ICU 通气患者的镇静剂暴露

基本信息

批准号：
7216791
负责人：
Linda L Chlan
金额：
$ 42.93万
依托单位：
UNIVERSITY OF MINNESOTA
依托单位国家：
美国
项目类别：
财政年份：
2006
资助国家：
美国
起止时间：
2006-04-01 至 2010-01-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7216791
关键词：
Acute Address Adult Adverse effects Affect American Analgesics Anxiety Area Biochemical Care given by nurses Caring Clinical Clinical Practice Guideline Clinical Trials Collection Condition Critical Care Critical Illness Daily Data Analyses Delirium Distress Dose Environment Equipment and supply inventories Evaluation Experimental Designs Exposure to Frequencies Future Goals Healed Health Hour Human Hydrocortisone Imagery Incidence Intensive Care Units Intervention Intervention Trial Intravenous Intubation Investigation Length Life Measures Mechanical ventilation Mechanics Medical Medicine Mind-Body Intervention Modality Muscle Weakness Music Music Therapy NIH Program Announcements National Institute of Nursing Research Noise Nurses Outcome Pain Participant Patients Persons Pharmaceutical Preparations Physiological Prevention Procedures Protocols documentation Psyche structure Quality of life Randomized Recruitment Activity Relaxation Reporting Research Research Personnel Research Priority Research Project Grants Respiratory Insufficiency Sampling Sedation procedure Self Management Severity of illness Societies Stimulus Stress Technology Testing Time Ventilator Visual Analogue Pain Scale biological adaptation to stress critical care nursing day desire experience healing innovation mind body interaction response sedative symptom management urinary

项目摘要

DESCRIPTION (provided by applicant): Mechanical ventilation is the most frequently used advanced, life-supportive modality in intensive care units (ICUs) to treat respiratory insufficiency from a variety of causes. To reduce anxiety, stress and promote tolerance of mechanical ventilation, nurses frequently administer sedative agents to these patients. While sedation is indicated at times, it is not without serious side effects which include muscle weakness, mental status changes, prolonged ventilatory support, and extended ICU stay. Clinical practice guidelines suggest that non-pharmacologic strategies be tried to reduce patient distress before administering sedatives. However, non-pharmacologic strategies are under-utilized and lack rigorous evaluation in clinical trials that document patient benefit. One non-pharmacologic intervention that shows promise in reducing anxiety after a single treatment but lacks rigorous evaluation on clinically salient outcomes is music. Thus, the primary aim of this clinical trial is to test a patient-directed, as desired music intervention (PDM) on reducing sedative exposure and anxiety in adult ventilated patients, and to examine attendant influences on length of ventilatory support, length of ICU stay, and stress modulation. A sample of 186 alert patients receiving acute ventilatory support will be recruited from 5 ICUs in the urban Midwest for this 3 group experimental design study with repeated measures. Subjects receiving ventilatory support will be randomized to PDM, noise- canceling headphones, or to usual care for up to 30 days. Sedative exposure (aggregate dose and dose frequency), anxiety levels (visual analog scale and State Anxiety Inventory), and 24-hour urinary cortisol samples (stress) will all be collected daily. Primary data analysis will be repeated measures ANCOVA, controlling for illness severity. Long-term objectives of this study are to positively impact important clinical outcomes and quality of life for the millions of ICU patients who experience mechanical ventilation each year by enhancing personal control while reducing exposure to sedative agents and their serious side effects.

描述（由申请人提供）：机械通气是重症监护病房 (ICU) 中最常用的先进生命支持方式，用于治疗各种原因引起的呼吸功能不全。为了减少焦虑、压力并提高机械通气的耐受性，护士经常给这些患者服用镇静剂。虽然有时需要使用镇静剂，但它并非没有严重的副作用，包括肌肉无力、精神状态改变、呼吸支持时间延长和 ICU 停留时间延长。临床实践指南建议在使用镇静剂之前尝试非药物策略来减轻患者的痛苦。然而，非药物策略并未得到充分利用，并且缺乏记录患者获益的临床试验的严格评估。音乐是一种非药物干预措施，它有望在单次治疗后减少焦虑，但缺乏对临床显着结果的严格评估。因此，该临床试验的主要目的是测试以患者为导向的按需音乐干预 (PDM)，以减少成人通气患者的镇静剂暴露和焦虑，并检查随之而来的对通气支持时间、ICU 住院时间的影响。和应力调制。将从中西部城市的 5 个 ICU 中招募 186 名接受急性通气支持的警觉患者作为样本，进行这项重复测量的 3 组实验设计研究。接受通气支持的受试者将被随机分配至 PDM、降噪耳机或常规护理，持续时间长达 30 天。每天都会收集镇静剂暴露（总剂量和剂量频率）、焦虑水平（视觉模拟量表和状态焦虑量表）和 24 小时尿皮质醇样本（压力）。主要数据分析将重复测量ANCOVA，控制疾病的严重程度。这项研究的长期目标是通过加强个人控制，同时减少镇静剂的接触及其严重副作用，对每年数百万接受机械通气的 ICU 患者的重要临床结果和生活质量产生积极影响。