Relieve the Patient's Thirst, Refresh the Mouth First
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Change of thirst intensity at 5 minutes from mint ice cubes application
研究概览
简要总结
Thirst is considered as one of the most distressing symptoms experienced by patients hospitalized in the Intensive Care Unit (ICU). Whereas pain is a permanent concern for all caregivers, thirst is often ignored and its complications are poorly known. Mechanisms involved in thirst regulation are numerous and complex. To date, care of thirst is still non optimal. Critically ill patients are usually rehydrated intravenously or using a naso-gastric tube, thus shunting the mouth as a therapeutic target to relieve the patient's thirst.
Water, cold and mint applied in mouth were studied separately and were shown to decrease thirst significantly on animal models and healthy humans.
Therefore, the hypothesis of this study is that application of small mint ice cubes in mouth of very dehydrated ICU patients should allow decreasing quickly and significantly thirst for these patients, before the correction of their biological parameters, like natremia and osmolarity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hypernatremia upper than 150mmol/L or hypernatremia upper than 145mmol/L associated with water deficiency upper than 3L
- •Estimated hospitalization duration in ICU upper than 24h
排除标准
- •Contraindication for ice cubes application in mouth
- •Known mint allergy
- •Incapability to understand study outcome and to answer basic questions
- •Pregnancy
- •Dying person
研究组 & 干预措施
Mint ice cubes
Physician applies 3 mint ice cubes in mouth of highly dehydrated patient. Patient undergoes an additional blood test at 5 min from mint ice cubes application.
Physician performs patient's questioning before mint ice cubes application and at 5 min, 1h, 2h, 4h, 12h and 24h from mint ice cubes application.
干预措施: Mint Ice Cube (Other)
Mint ice cubes
Physician applies 3 mint ice cubes in mouth of highly dehydrated patient. Patient undergoes an additional blood test at 5 min from mint ice cubes application.
Physician performs patient's questioning before mint ice cubes application and at 5 min, 1h, 2h, 4h, 12h and 24h from mint ice cubes application.
干预措施: Blood test (Procedure)
Mint ice cubes
Physician applies 3 mint ice cubes in mouth of highly dehydrated patient. Patient undergoes an additional blood test at 5 min from mint ice cubes application.
Physician performs patient's questioning before mint ice cubes application and at 5 min, 1h, 2h, 4h, 12h and 24h from mint ice cubes application.
干预措施: Patient's questioning (Other)
结局指标
主要结局
Change of thirst intensity at 5 minutes from mint ice cubes application
时间窗: at 5 minutes from mint ice cubes application
The primary endpoint is a change of thirst intensity of at least 1.5 points on the thirst intensity scale at 5 minutes from mint ice cubes application. Thirst intensity scale is a numeric scale ranging from 0 to 10 points. 0 corresponds to no thirst (the best outcome). 10 corresponds to a thirst of the strongest possible intensity (the worst outcome).
次要结局
- Change of thirst-associated discomfort at 5 minutes from mint ice cubes application(at 5 minutes from mint ice cubes application)
- Duration of the observed effect on thirst intensity(over 24 hours from mint ice cubes application)
- Change of natremia at 24 hours from mint ice cubes application(at 24 hours from mint ice cubes application)
- Time of appearance of the observed effect on thirst intensity(over 24 hours from mint ice cubes application)
- Change of natremia at 5 minutes from mint ice cubes application(at 5 minutes from mint ice cubes application)
- Change of plasma osmolarity at 5 minutes from mint ice cubes application(at 5 minutes from mint ice cubes application)
- Change of plasma osmolarity at 24 hours from mint ice cubes application(at 24 hours from mint ice cubes application)