Use of Connected Glasses to Help the Communication of Non Temporarily Speaking Patients in Intensive Care Unit : a Pilot Study (CASTOR-REA)
Hospitalization in an intensive care unit (ICU) is accompanied by major physical and emotional stress for patients, a source of discomfort and a risk factor for post-resuscitation syndrome. Efficient patient-caregiver and patient-family communication is needed to: understand the patient's symptoms in order to relieve them, understand the patient's primary needs, understand the patient's questions and concerns in order to respond to them, rehumanize our care and re-establish a more balanced relationship with the patient. However, communication with the patient is often limited, due for example to invasive mechanical ventilation: it is estimated that half of intubated patients meet basic communication criteria (calm patient responding to simple commands and verbal requests) after 2 days of mechanical ventilation, without however being able to express themselves verbally.
Augmentative and alternative communication tools exist, ranging from pictograms and slates to voice synthesizers, and are used in ICU. The critical care departments of the University Hospitals of Marseille and Tours use a communication interface consisting of a mobile screen with eye tracking for vigilant patients unable to communicate verbally, which seems to have been appreciated by patients and their families, although its effect has not been measured.
Connected glasses are one of the tools available. These are pairs of glasses fitted with infrared sensors that detect a signal predefined with the patient (such as a wink) and thus enable a tablet with customized communication software to be clicked on and navigated. Potential advantages over eye tracking, which has already been used in critical care departments, include: use in low-light conditions, smaller size (no need for an arm to adjust screen orientation), less concentration (eye tracking requires precise, sustained eye fixation).
The objective is to conduct a pilot study to assess the feasibility of using this tool in non temporarily speaking patients hospitalized in ICU.
研究概览
地位
详细说明
- The main objective of this pilot study is to evaluate the ability of ICU patients, who are vigilant but unable to communicate verbally, to use connected glasses as a communication aid.
- The secondary objectives are to assess the limitations to the use of the communication aid and to measure the qualitative and quantitative impact of the communication tool.
- Course of the study : Participation in the study is offered to any patient hospitalized in the department for a foreseeable period of ≥ 48 hours and whose clinical condition corresponds to the selection criteria. After oral and written information, the patient's non-opposition is collected and consigned in the information notice in the patient's file. Calibration of the connected glasses is carried out with the patient by trained medical and nursing staff (choice of personalized signal to control the cursor on the electronic tablet). Then, the connected glasses are put on the patient by the medical and nursing staff for an exchange session facilitated by the communication interface (no predefined duration): at least at each monitoring round (every 4 hours except during the night round if the patient is asleep) and during the medical visit each morning. Installation and actual use times are timed. Outcomes (see below) are collected on a Case Report Form (CRF) at the patient's bedside. Use of the connected glasses is temporarily suspended if the patient's condition no longer allows him/her to use it (onset of confusion, change in neurological status, deterioration in helath state). It may be resumed if the patient's condition subsequently improves.
The study ends:
- when the patient is able to communicate verbally (e.g. extubation, decanulation) or using the slate (e.g. recovery of sufficient motor skills to use the slate correctly);
- or when the patient is discharged from the ICU;
- or after a maximum of 1 month's use of the tool for each patient.
- After the study : there is no other data collected, the patient will not be contacted relating to the study.
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名：Audrey BARON, PhD
- 电话号码：+33 1 56 01 51 84
- 邮箱：audreypaule.baron@aphp.fr
研究联系人备份
- 姓名：Aude GIBELIN, PhD
- 电话号码：+ 33 1 56 01 50 29
- 邮箱：aude.gibelin@aphp.fr
学习地点
-
-
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Paris、法国、75020
- Service Médecine Intensive Réanimation Tenon Hospital
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-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
取样方法
研究人群
描述
Inclusion Criteria:
- Adult patients hospitalized in the Intensive Care Medicine Department of the Tenon Hospital, whatever their reason for admission to the department
- Neuropsychiatric state compatible with the development of a coherent dialogue: good vigilance attested by a RASS -1 to +1 (Richmond Agitation Sedation Scale), no confusion attested by a negative CAM-ICU test (Confusion Assessment Method for the Intensive Care Unit), no sedative treatment or light sedative treatment
- Physically unable to communicate verbally for a foreseeable period of at least 48 hours, which may be linked to invasive mechanical ventilation (with endotracheal tube or tracheotomy without phonatory cannula) or to a speech and/or phonation disorder whatever the cause (eg: after-effects of ENT surgery, laryngeal oedema, etc.).
- Have expressed no objection to participating in the study.
Exclusion Criteria:
- Neuropsychiatric state incompatible with the development of a coherent dialogue: agitation (RASS ≥ 2) or somnolence (RASS ≤ -2), confusion (CAM-ICU positive)
- Simple, fluid appropriation by the patient of the slate as a communication tool : no motor deficit of the dominant upper limb, no graphic problems, no language barrier
- Inability of patient to use connected glasses: blindness, eye conditions preventing eye opening, vision disorders without corrective lenses available, known patent cognitive disorders, mental retardation
学习计划
研究是如何设计的？
设计细节
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Median daily time spent actually using the connected glasses during the study.
大体时间：7 month
|
This is the median of daily usage times from the beginning to the end of the study.
Every day, the actual use of the tool (yes/no) is collected and the use of the connected glasses is timed (thanks to the stopwatch available on the patient monitor).
|
7 month
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
To assess limitations to the tool use
大体时间：7 month
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Tool installation time (timed by the caregiver interacting with the patient)
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7 month
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To assess limitations to the tool use
大体时间：7 months
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reason for not using the tool (change in patient condition temporarily incompatible with use of the tool, occurrence of malfunctions)
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7 months
|
|
To assess limitations to the tool use
大体时间：1 month
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satisfaction questionnaire and profile (age, gender, function) of the member of the care team in charge of the patient
|
1 month
|
|
To assess limitations to the tool use
大体时间：7 months
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occurrence of malfunctions (yes/no)
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7 months
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To assess limitations to the tool use
大体时间：7 months
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type of malfunction (technical failure, battery not charged, unfamiliarity of caregivers with the tool, lack of space or inappropriate positioning of the tool, lack of caregiver time)
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7 months
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To assess the qualitative and quantitative impact of the communication tool
大体时间：1 month
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Communication ease questionnaire (10-item Ease of Communication Scale using a 5-level Likert scale, previously validated in psychometrics)
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1 month
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To assess the qualitative and quantitative impact of the communication tool
大体时间：1 month
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satisfaction questionnaire and profile (age, sex) of the doctor in charge of the patient, administration of psychotropic drugs (molecules and doses)
|
1 month
|
|
To assess the qualitative and quantitative impact of the communication tool
大体时间：1 month
|
use of physical restraint (yes/no)
|
1 month
|
合作者和调查者
调查人员
- 首席研究员：Audrey BARON, PhD、Assistance Publique - Hôpitaux de Paris
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- APHP250022
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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