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NCT05473351: THIRST
Thirst in the Intensive Care Unit, Recognition, Sensitivity and Type
trial testing Questionnaire in Thirst in Intensive Care Unit (ICU) Practice in 203 participants. Completed in 29 October 2024.
29 October 2024
Quick facts
| Lead sponsor | Assistance Publique - Hôpitaux de Paris |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 203 |
| Start date | 29 December 2022 |
| Primary completion | 29 October 2024 |
| Estimated completion | 29 October 2024 |
| Sites | 3 locations across France |
Drugs / interventions tested
- Questionnaire
Conditions studied
- Thirst in Intensive Care Unit (ICU) Practice — all drugs for Thirst in Intensive Care Unit (ICU) Practice →
Sponsor
Assistance Publique - Hôpitaux de Paris — full company profile →
Who can join
18 and older, any sex, with Thirst in Intensive Care Unit (ICU) Practice. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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. Patient 18 years of age and older 2. Patients undergoing invasive mechanical ventilation for at least 24 hours at one of the participating centers 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. Subjects meeting the inclusion and non-inclusion criteria (with the exception of the delirium test) will be informed of the study by the principal investigator or any other investigator trained and declared in the research. The oral information will be completed by the delivery of an information note. Patients who wish to participate in the study will be given up to 24 hours to consider their decision. If the patient agrees to participate in the study, his or her non-opposition is collected by the investigator on a dedicated form in duplicate. One copy will be given to the patient, and the other will be kept in the department with the research documents. In case of suspected confusion, a delirium screening test (CAM-ICU) will be performed to verify the patient's eligibility. If the test confirms the presence of confusion, the patient will be excluded from the study. The information and the collection of the non-opposition will be notified in the patient's medical file. Following their inclusion, patients are assessed only once during their stay in the ICU: the day of inclusion. Once enrolled, patients are asked to rate the intensity of thirst by placing a cursor on a 100 mm visual analog scale (VAS) bounded on the left by "not thirsty" and on the right by "intolerably thirsty". If a patient understands the principle of the assessment but is unable to move the VAS cursor himself, the observer assists the patient by holding the scale and supporting the patient's forearm. If the subject is unable to move his or her arms (as in some cases of severe neuromuscular impairment), observers are allowed to manipulate the VAS slider following the patient's instructions. However, this is not recommended and should be avoided whenever possible. The slider should never be adjusted directly or solely by the investigator. The visual analog scales for dry mouth, anxiety, pain and dyspnea will be performed as part of the protocol after the thirst assessment. The oral status, the search for edema or skin folds and the Revised Oral Assessment Guide (ROAG) score for intubated patients will also be performed at the same time. An average of 20 minutes is necessary to perform all these procedures.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05473351
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05473351 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Assistance Publique - Hôpitaux de Paris
- Last refreshed: 14 July 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05473351.
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