Palliation of Thirst in Intensive Care Unit Patients

描述(由申请者提供)：这项研究将测试一种创新的、廉价的、资源高效的口渴治疗方法的有效性。口渴是重症监护病房(ICU)中的危重患者遭受的最普遍、最强烈、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ICU患者口渴的非药物干预。这项干预是针对口渴的综合疗法(CTT)，包括使用无菌水口腔喷雾剂、无菌水拭子和薄荷醇基唇舌保湿霜。这项研究的第二个目的是检查人口统计、环境、健康和疾病因素，这些因素增加了ICU患者口渴的风险。目的1假设：(1)与研究组观察者相比，接受CTT治疗的ICU患者的口渴强度和苦恼程度将显著降低。(2)与接受研究组观察的患者相比，接受CCT治疗的ICU患者的主观(例如口干)和客观(例如嘴唇破裂)与口渴相关的特征将显著减少。目的#2假设：(1)口渴的存在与某些口渴危险因素之间存在显著的关联，如血清渗透压、水合状态和某些药物的使用，如阿片类药物。(2)将发现口渴的强度与某些口渴风险因素之间存在显著的关联，例如血清渗透压、水合状态和某些药物的使用，例如阿片类药物。样本将是245名ICU患者，其中一组为试验组，两组为对照组。那些口渴的人将被随机分到试验组或对照1组。试验组将接受CTT；对照1组将接受研究小组观察。报告没有口渴的对照2组患者将在与口渴的存在和强度相关的特征上与对照1组进行比较。将使用多水平线性回归模型来检验治疗组和对照组之间的线性变化轨迹的差异。多元Logistic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。结果将有助于提供所需的经验数据，以刺激早就应该在ICU治疗口渴的护理实践的改变。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。 与公共卫生相关：重症监护病房的患者往往因为他们的药物、疾病、治疗或他们接受的药物而极度口渴。这项研究将测试接受易于实施的干渴干预的患者是否会比一组没有接受干预的患者获得更大的缓解口渴的效果。这项研究还将确定使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/或使干渴的干预更容易获得。

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.