Palliation of Thirst in Intensive Care Unit Patients

描述（由申请人提供）：这项研究将测试一种创新的，廉价的，资源有效的治疗口渴的疗效-这是重症监护室（ICU）中重症患者最普遍，强烈，未被识别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ICU患者口渴的非药物干预。干预是一种针对口渴的联合治疗（CTT），包括使用无菌水口腔喷雾剂，无菌水拭子和薄荷基唇和舌保湿剂。该研究的第二个目的是检查增加ICU患者口渴风险的人口统计学，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患者相比，接受CTT治疗口渴的ICU患者的口渴强度和痛苦将显著降低。(2)主观（例如，口干）和客观（例如，与接受研究小组观察的患者相比，接受CCT治疗口渴的ICU患者的口渴相关特征将显著降低。目标#2假设：（1）在口渴的存在和口渴的某些风险因素之间会发现显著的关联，例如，血清渗透压、水合状态和某些药物的施用，例如，阿片类药物。(2)在口渴的强度和口渴的某些危险因素之间会发现显著的关联，例如，血清渗透压、水合状态和某些药物的施用，例如，阿片类药物。 样本将为一个实验组和两个对照组中的245名ICU患者。口渴的人将被随机分配到实验组或对照组1。实验组将接受CTT;对照1组将接受研究团队观察。将报告无口渴的对照2组患者与对照1组在与口渴的存在和强度相关的特征方面进行比较。 将采用多水平线性回归模型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。 结果将有助于经验数据需要刺激一个姗姗来迟的护理实践的变化，治疗口渴的ICU。研究结果还将确定口渴的风险特征，这将是未来ICU患者口渴研究的重要目标。 公共卫生相关性：重症监护室的患者通常由于他们的药物，疾病，治疗或药物而非常口渴。这项研究将测试接受易于实施的口渴干预的患者是否比未接受干预的患者更能缓解口渴。该研究还将确定使ICU患者口渴的最重要因素，以便未来的研究可以测试如何缓解这些因素和/或更容易地进行口渴干预。

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.