Relieve the Patient's Thirst, Refresh the Mouth First (ICU-MIC)

Study Overview
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Brief Summary
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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.

Official Title
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Relieve the Patient's Thirst, Refresh the Mouth First

Conditions
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Hypernatremia, Dehydration

Intervention / Treatment
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* Other: Mint Ice Cube
* Procedure: Blood test
* Other: Patient's questioning


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Contraindication for ice cubes application in mouth Known mint allergy Incapability to understand study outcome and to answer basic questions Pregnancy Dying person

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Interventional Model Description: Adult patient displaying an hypernatremia upper than 150mmol/L or an hypernatremia upper than 145mmol/L associated with a water deficiency upper than 3L
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mint ice cubes<br>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. | Other: Mint Ice Cube<br>* Application in patient's mouth of 3 mint ice cubes<br>Procedure: Blood test<br>* Additional blood test 5 min after mint ice cubes application<br>Other: Patient's questioning<br>* Patient's questioning before mint ice cubes application and at 5 min, 1h, 2h, 4h, 12h and 24h from mint ice cubes application<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of thirst intensity 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). | at 5 minutes from mint ice cubes application | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of thirst-associated discomfort at 5 minutes from mint ice cubes application | This secondary endpoint is a change of thirst-associated discomfort on the discomfort scale at 5 minutes from mint ice cubes application. The discomfort scale is a numeric scale ranging from on a 0 to 5 points. 0 corresponds to very comfortable (the best outcome). 5 corresponds to very uncomfortable (the worst outcome). | at 5 minutes from mint ice cubes application | 
| Time of appearance of the observed effect on thirst intensity | This secondary endpoint is the delay (in minutes) between mint ice cubes application and the observed effect on thirst intensity. | over 24 hours from mint ice cubes application | 
| Duration of the observed effect on thirst intensity | This secondary endpoint measures how much time (in minutes) mint ice cubes application keeps working on thirst intensity. | over 24 hours from mint ice cubes application | 
| Change of natremia at 5 minutes from mint ice cubes application | Natremia (in mmol/L) | at 5 minutes from mint ice cubes application | 
| Change of natremia at 24 hours from mint ice cubes application | Natremia (in mmol/L) | at 24 hours from mint ice cubes application | 
| Change of plasma osmolarity at 5 minutes from mint ice cubes application | Plasma osmolarity (in mmol/L) | at 5 minutes from mint ice cubes application | 
| Change of plasma osmolarity at 24 hours from mint ice cubes application | Plasma osmolarity (in mmol/L) | at 24 hours from mint ice cubes application | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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thirst, mouth, critical care, water deprivation