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功效，口渴是重症监护病房 (ICU) 重症患者最普遍、最强烈、未被识别和治疗不足的症状之一。这项单盲、随机临床试验的首要目的是测试针对 ICU 患者口渴的非药物干预措施。该干预措施是针对口渴的联合疗法（CTT），包括使用无菌水口腔喷雾剂、无菌水拭子以及薄荷醇唇舌保湿剂。该研究的第二个目的是检查增加 ICU 患者口渴风险的人口、环境、健康和疾病因素。目标 1 假设：(1) 与接受研究团队观察的患者相比，接受口渴 CTT 的 ICU 患者的口渴强度和痛苦会显着降低。 (2) 与接受研究团队观察的患者相比，接受口渴 CCT 的 ICU 患者的主观（例如口干）和客观（例如嘴唇干裂）口渴相关特征将显着下降。目标 #2 假设：(1) 口渴的存在与口渴的某些危险因素（例如血清渗透压、水合状态和某些药物（例如阿片类药物）的使用）之间存在显着关联。 (2) 口渴强度与口渴的某些危险因素之间存在显着关联，例如血清渗透压、水合状态和某些药物（例如阿片类药物）的使用。 样本为 245 名 ICU 患者，分为一组实验和两组对照组。那些口渴的人将被随机分配到实验组或控制组 1。实验组将获得CTT；对照1组将接受研究小组观察。将报告不口渴的对照 2 组患者与对照 1 组患者在与口渴的存在和强度相关的特征上进行比较。 将采用多级线性回归模型来测试治疗组和对照组之间线性变化轨迹的差异。将使用多元逻辑回归分析和多元线性回归分析分别确定危险因素与口渴的存在和强度的关联。 结果将提供所需的经验数据，以刺激 ICU 治疗口渴的护理实践变革，这是早该发生的。结果还将确定口渴的风险概况，这将成为未来 ICU 患者口渴研究的重要目标。 公共健康相关性：重症监护病房的患者常常因药物、疾病、治疗或接受的药物而极度口渴。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。该研究还将确定导致 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/或更容易地采取口渴干预措施。

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.