跳至主要内容
临床试验/NCT05473351
NCT05473351已完成不适用

Thirst in the Intensive Care Unit, Recognition, Sensitivity and Type

Assistance Publique - Hôpitaux de Paris3 个研究点 分布在 1 个国家目标入组 203 人开始时间: 2022年12月29日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
203
试验地点
3
主要终点
:Assessment of thirst in mechanically ventilated patients.

研究概览

简要总结

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.

详细描述

Thirst was reported in 70% of symptom assessments of intensive care patients. Thirst is a major source of physical discomfort. This should make it a concern for clinicians and ICU nurses whose mission is to alleviate symptoms in addition to treating pathology.

Balancing extracellular and intracellular volume is a goal in the poorly communicating patient with no spontaneous access to water. Thirst may exist, persist, reappear, or increase again after the institution of water intake; it may reveal changes in the intra/extra sector or inappropriate intakes. Thirst could therefore be useful as a clinical management tool. However, it has not been studied to any great extent in mechanically ventilated patients.

Neglecting thirst in these circumstances is bound to cause suffering. This neglect may also offset the physiological benefits in terms of clinical outcomes. It could also have a negative impact at a distance through negative memories. Nevertheless, thirst is not routinely assessed in ICU patients, except after extubation when the patient has access to spontaneous hydration.

Mechanically ventilated patients have multiple causes of thirst and dry mouth and at the same time have difficulty communicating and limited access to water. It is essential to study thirst in this population. In particular, determining the prevalence of thirst in this population would raise awareness of its screening. Finally, understanding the main mechanisms involved in thirst in patients undergoing invasive mechanical ventilation would allow the development of therapeutic solutions to minimize it.

In this context, the investigators wish to conduct a prospective observational study in mechanically ventilated patients able to communicate in order to better understand the prevalence, intensity, mechanisms and prognostic value of thirst as well as the sensation of dry mouth. They will also focus on the relationship of thirst with dyspnea, anxiety and pain.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Exclusion Criteria :
  • 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

结局指标

主要结局

:Assessment of thirst in mechanically ventilated patients.

时间窗: Through study completion, an average of 1 year

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

次要结局

  • 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 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 dry mouth in mechanically ventilated patients.(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)
  • Evaluation of the association between thirst and dyspnea in mechanically ventilated patients.ventilated patients.(Through study completion, an average of 1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

Loading locations...

相似试验