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

Not Applicable

Completed

• Conditions: Hypernatremia; Dehydration
• Interventions: Other: Mint Ice Cube; Procedure: Blood test; Other: Patient's questioning

• Registration Number: NCT03610074
• Lead Sponsor: Centre Hospitalier Arras

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-04-23
• Study First Submitted: 2018-06-21
• Study First Submitted QC: 2018-07-25
• Study First Posted: 2018-08-01
• Status Verified: 2019-03
• Primary Completion: 2019-03-08
• Study Completion: 2019-03-08
• Last Update Submitted: 2019-03-29
• Last Update Posted: 2019-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Mint ice cubes	Mint Ice Cube	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.
Mint ice cubes	Patient's questioning	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.
Mint ice cubes	Blood test	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.

Primary Outcome Measures

Name	Time	Method
Change of thirst intensity at 5 minutes from mint ice cubes application	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).

Secondary Outcome Measures

Name	Time	Method
Change of thirst-associated discomfort at 5 minutes from mint ice cubes application	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).
Duration of the observed effect on thirst intensity	over 24 hours from mint ice cubes application	This secondary endpoint measures how much time (in minutes) mint ice cubes application keeps working on thirst intensity.
Change of natremia at 24 hours from mint ice cubes application	at 24 hours from mint ice cubes application	Natremia (in mmol/L)
Time of appearance of the observed effect on thirst intensity	over 24 hours from mint ice cubes application	This secondary endpoint is the delay (in minutes) between mint ice cubes application and the observed effect on thirst intensity.
Change of natremia at 5 minutes from mint ice cubes application	at 5 minutes from mint ice cubes application	Natremia (in mmol/L)
Change of plasma osmolarity at 5 minutes from mint ice cubes application	at 5 minutes from mint ice cubes application	Plasma osmolarity (in mmol/L)
Change of plasma osmolarity at 24 hours from mint ice cubes application	at 24 hours from mint ice cubes application	Plasma osmolarity (in mmol/L)

Trial Locations

Locations (2)

Centre Hospitalier de Lens; 🇫🇷 Lens, France

Centre Hospitalier d'Arras; 🇫🇷 Arras, France