Palliation of Thirst in Intensive Care Unit Patients

描述（由申请人提供）：本研究将测试一种创新、廉价、资源高效的口渴治疗方法的疗效——口渴是重症监护病房（icu）危重患者最普遍、最严重、最未被认识和治疗不足的症状之一。这项单盲随机临床试验的第一个目的是测试非药物干预对ICU患者口渴的影响。干预是一种针对口渴的综合治疗（CTT），包括使用无菌水口腔喷雾剂、无菌水拭子和薄荷醇唇舌润肤霜。该研究的第二个目的是检查增加ICU患者口渴风险的人口、环境、健康和疾病因素。目标1假设：(1)与接受研究小组观察的ICU患者相比，接受CTT治疗的患者口渴强度和痛苦会显著降低。(2)与接受研究组观察的ICU患者相比，接受CCT治疗的患者主观（如口干）和客观（如嘴唇干裂）口渴相关特征显著降低。目标2假设：(1)将发现口渴的存在与某些口渴的危险因素（如血清渗透压、水合状态和某些药物（如阿片类药物）的使用）之间存在显著关联。(2)口渴的强度与某些口渴的危险因素（如血清渗透压、水合状态和某些药物（如阿片类药物）的使用）之间存在显著关联。样本为245例ICU患者，分为实验组和对照组。口渴的人将被随机分为实验组和对照组。实验组接受CTT；对照组由课题组观察。报告无口渴的对照2组患者将与对照1组进行与口渴的存在和强度相关的特征比较。我们将采用多水平线性回归模型来检验治疗组和对照组之间线性变化轨迹的差异。多元逻辑回归分析和多元线性回归分析将分别用于确定危险因素与口渴的存在和强度的关联。研究结果将提供必要的经验数据，以刺激icu中治疗口渴的护理实践改变。结果还将确定口渴的风险概况，这将是未来ICU患者口渴研究的重要目标。

DESCRIPTION (provided by applicant): This study will test the efficacy of an innovative, inexpensive, resource-efficient treatment for thirst -- one of the most pervasive, intense, unrecognized, and under-treated symptoms suffered by critically ill patients in Intensive Care Units (ICUs). The first aim of this single-blinded, randomized clinical trial is to test a non-pharmacologic intervention for thirst in ICU patients. The intervention is a combination therapy treatment (CTT) for thirst that includes the use of sterile water mouth sprays, sterile water swabs, and menthol-based lip and tongue moisturizer. The second aim of the study is to examine demographic, environmental, and health and illness factors that increase an ICU patient's risk profile for thirst. Aim #1 hypotheses: (1) Thirst intensity and distress will decrease significantly in ICU patients who receive a CTT for thirst compared to those who receive research team observation. (2) Subjective (e.g., dry mouth) and objective (e.g., cracked lips) thirst-related characteristics will decrease significantly in ICU patients who receive a CCT for thirst compared to those who receive research team observation. Aim #2 hypotheses: (1) A significant association will be found between presence of thirst and certain risk factors for thirst, e.g., serum osmolality, hydration status, and administration of certain medications, e.g., opioids. (2) A significant association will be found between the intensity of thirst and certain risk factors for thirst, e.g., serum osmolality, hydration status, and administration of certain medications, e.g., opioids. The sample will be 245 ICU patients in one Experimental and two Control groups. Those with thirst will be randomized to either the Experimental or the Control 1 group. The Experimental group will receive the CTT; the Control 1 group will receive research team observation. The Control 2 group patients who reported no thirst will be compared to the Control 1 group on characteristics associated with the presence and intensity of thirst. Multilevel linear regression models will be employed to test the difference in the linear change trajectories between the treatment and control groups. Multiple logistic regression analysis and multiple linear regression analysis will be used to determine association of risk factors with the presence and intensity of thirst, respectively. Results will contribute empirical data needed to stimulate a far overdue nursing practice change for the treatment of thirst in ICUs. Results will also identify a risk profile for thirst that will be an important target for future research of thirst in ICU patients. PUBLIC HEALTH RELEVANCE: Patients in Intensive Care Units are often extremely thirsty due to their medicines, illness, treatments or medicines that they receive. This study will test whether patients who receive an easy to implement intervention for thirst will have greater relief from thirst than a group of patients who do not receive the intervention. The study will also identify the most important factors that make ICU patients thirsty so that future research studies can test how to relieve those factors and/or make interventions for thirst more readily available.