NCT05473351

Brief Summary

Thirst is a perception that provokes the desire to drink liquids. It is a multidimensional symptom that is described in terms of intensity and distress and is associated with dry mouth, called xerostomia. Thirst is poorly recognized in intensive care unit practice. Yet, research has shown that it is one of the most prevalent, most intense, and least well treated symptoms in intensive care patients. Thirst and dry mouth are associated with physical discomfort in the ICU. However, thirst often goes unnoticed and untreated. In this context, The investigators aim to conduct a prospective observational study in mechanically ventilated patients able to communicate to better understand the prevalence, intensity, mechanisms and prognostic value of thirst as well as dry mouth sensation. Primary objective: to assess thirst in mechanically ventilated patients. Primary endpoint: visual analog thirst scale from 0 mm (no thirst) to 100 mm (maximal thirst)

  1. 1.Patient 18 years of age and older
  2. 2.Patients undergoing invasive mechanical ventilation for at least 24 hours at one of the participating centers
  3. 3.No objection to participation in the study During the study period, patients from 3 resuscitation sites are systematically screened for inclusion in the study on a daily basis, between 9:00 am and 12:00 pm.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
203

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2022

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 12, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 25, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

December 29, 2022

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 29, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 29, 2024

Completed
Last Updated

July 14, 2025

Status Verified

July 1, 2025

Enrollment Period

1.8 years

First QC Date

July 12, 2022

Last Update Submit

July 9, 2025

Conditions

Keywords

ThirstIntensive care unit,Cohort

Outcome Measures

Primary Outcomes (1)

  • :Assessment of thirst in mechanically ventilated patients.

    visual analog thirst scale from 0 mm (no thirst) to 100 mm (maximum thirst)

    Through study completion, an average of 1 year

Secondary Outcomes (6)

  • Evaluation of the association between thirst and dry mouth in mechanically ventilated patients.

    Through study completion, an average of 1 year

  • Evaluation of the association between thirst and oral status in mechanically ventilated patients.

    Through study completion, an average of 1 year

  • valuation of the association between thirst and extracellular volume in ventilated patients

    Through study completion, an average of 1 year

  • Evaluation of the association between thirst and anxiety in the mechanically ventilated patient.

    Through study completion, an average of 1 year

  • Evaluation of the association between thirst and pain in mechanically ventilated patients.

    Through study completion, an average of 1 year

  • +1 more secondary outcomes

Study Arms (1)

Thirst

Patients undergoing invasive mechanical ventilation for at least 24 hours in one of the participating centers

Other: Questionnaire

Interventions

Visual Analogic Scale

Thirst

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients on invasive mechanical ventilation, admitted to one of the participating centers

You may qualify if:

  • Patient 18 years of age and older
  • Patients undergoing invasive mechanical ventilation for at least 24 hours at one of the participating centers
  • No objection to participation in the study

You may not qualify if:

  • Patients unable to communicate verbally and reliably self-report thirst:
  • Richmond Agitation-Sedation Scale (RASS) \< -2 or \> +2,
  • delirium according to the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) (if confusion is suspected)
  • severe cognitive impairment or severe mental illness
  • non-French speaking patients
  • severe hearing loss.
  • Pregnant women
  • Adults under legal protection
  • Not affiliated to a social security system or not benefiting from such a system

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Service de médecine intensive et réanimation, hôpital Avicenne

Bobigny, 93000, France

Location

Service de médecine intensive et réanimation, hôpital Saint-Louis

Paris, 75010, France

Location

Service de medecine intensive et réanimation, hôpital Pitié Salpêtrière

Paris, 75013, France

Location

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 12, 2022

First Posted

July 25, 2022

Study Start

December 29, 2022

Primary Completion

October 29, 2024

Study Completion

October 29, 2024

Last Updated

July 14, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will share

The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor
Access Criteria
Researchers who provide a methodologically sound proposal

Locations