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Use of Connected Glasses to Help the Communication of Non Temporarily Speaking Patients in Intensive Care Unit : a Pilot Study (CASTOR-REA)

2026年8月17日更新者：Assistance Publique - Hôpitaux de Paris

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.

調査の概要

状態

まだ募集していません

条件

詳細な説明

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.

研究の種類

観察的

入学 (推定)

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

名前：Audrey BARON, PhD
電話番号：+33 1 56 01 51 84
メール：audreypaule.baron@aphp.fr

研究連絡先のバックアップ

名前：Aude GIBELIN, PhD
電話番号：+ 33 1 56 01 50 29
メール：aude.gibelin@aphp.fr

研究場所

フランス
- - Paris、フランス、75020
    - Service Médecine Intensive Réanimation Tenon Hospital

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

大人
高齢者

健康ボランティアの受け入れ

いいえ

サンプリング方法

非確率サンプル

調査対象母集団

Adult patients hospitalized in the Intensive Care Medicine Department of the Tenon Hospital using connected glasses with electronic tablet and communication software

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

この研究は何を測定していますか？

主要な結果の測定

結果測定	メジャーの説明	時間枠
Median daily time spent actually using the connected glasses during the study. 時間枠：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

二次結果の測定

結果測定	メジャーの説明	時間枠
To assess limitations to the tool use 時間枠：7 month	Tool installation time (timed by the caregiver interacting with the patient)	7 month
To assess limitations to the tool use 時間枠：7 months	reason for not using the tool (change in patient condition temporarily incompatible with use of the tool, occurrence of malfunctions)	7 months
To assess limitations to the tool use 時間枠：1 month	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 時間枠：7 months	occurrence of malfunctions (yes/no)	7 months
To assess limitations to the tool use 時間枠：7 months	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)	7 months
To assess the qualitative and quantitative impact of the communication tool 時間枠：1 month	Communication ease questionnaire (10-item Ease of Communication Scale using a 5-level Likert scale, previously validated in psychometrics)	1 month
To assess the qualitative and quantitative impact of the communication tool 時間枠：1 month	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 時間枠：1 month	use of physical restraint (yes/no)	1 month

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Assistance Publique - Hôpitaux de Paris

捜査官

主任研究者：Audrey BARON, PhD、Assistance Publique - Hôpitaux de Paris

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年10月1日

一次修了 (推定)

2028年4月1日

研究の完了 (推定)

2028年5月1日

試験登録日

最初に提出

2025年12月12日

QC基準を満たした最初の提出物

2026年8月17日

最初の投稿 (実際)

2026年8月20日

学習記録の更新

投稿された最後の更新 (実際)