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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Median daily time spent actually using the connected glasses during the study.

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).

Time frame
7 month

Secondary outcomes

1

To assess limitations to the tool use

Tool installation time (timed by the caregiver interacting with the patient)

Time frame
7 month
2

To assess limitations to the tool use

reason for not using the tool (change in patient condition temporarily incompatible with use of the tool, occurrence of malfunctions)

Time frame
7 months
3

To assess limitations to the tool use

satisfaction questionnaire and profile (age, gender, function) of the member of the care team in charge of the patient

Time frame
1 month
4

To assess limitations to the tool use

occurrence of malfunctions (yes/no)

Time frame
7 months

Other outcomes

Sponsors and contacts

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