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

Relieve the Patient's Thirst, Refresh the Mouth First

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.

Study Overview

• Status: Completed
• Conditions: Dehydration; Hypernatremia
• Intervention / Treatment: Other: Mint Ice Cube; Procedure: Blood test; Other: Patient's questioning

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Arras, France
    • Centre Hospitalier D'arras
  • Lens, France
    • Centre Hospitalier de LENS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Arras

Study record dates

Study Major Dates

• Study Start (Actual): April 23, 2018
• Primary Completion (Actual): March 8, 2019
• Study Completion (Actual): March 8, 2019

Study Registration Dates

• First Submitted: June 21, 2018
• First Submitted That Met QC Criteria: July 25, 2018
• First Posted (Actual): August 1, 2018

Study Record Updates

• Last Update Posted (Actual): April 1, 2019
• Last Update Submitted That Met QC Criteria: March 29, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: critical care; mouth; thirst; water deprivation
• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Water-Electrolyte Imbalance; Dehydration; Hypernatremia
• Other Study ID Numbers: 2017-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No