Eye-Control Trial: Wearable Eye-Tracking Device as Means of Communication

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the feasibility of use of a wearable communication device for critically ill patients who are admitted to the intensive care unit (ICU) and mechanically ventilated. The study will assess the safety, tolerability, and ease of use of the EyeControl device, and examine its potential monitoring capabilities.

Detailed Description
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Critically ill patients, who are mechanically ventilated, suffer not only from their acute, potentially devastating illness, but also from the lack of ability to communicate in an effective manner. This is the direct result of the orotracheal tube or tracheostomy required for the mechanical ventilation, which does not allow speech to be produced. On top of the mechanical change in air flow, communication challenges result from sedation, neurological injuries (primary brain injury or secondary encephalopathy), and delirium. Lack of communication can lead to increased frustration, anxiety, and overall psychological stress and could continue to the development of post-traumatic stress disorder (PTSD). On top of the subjective discomfort, the inability to communicate in an effective manner may impair medical care-for example, by failure to assess symptoms such as pain or breathing discomfort by behavioral cues only. Currently, the solutions for communication deficits in mechanically ventilated patients are mainly using yes/no communication, attempting to write, and communication boards that allow people to point at defined pictures or letters. Recently, technological advancements led to incorporation of more sophisticated communication devices, proving the feasibility of an eye-tracking approach, for example. The EyeControl is a new, wearable, eye-tracking device that facilitates communication by means of internal feedback to the patients with a bone-conducting speaker. In this way, the device can ask the patient what he or she wants to say, and the patient replies by eye gestures such as blinking or moving the eyes in a certain direction. This approach eliminates the need for calibration, as most eye-tracking devices that use a screen require, and is relatively easy to operate. This study will assess the safety, tolerability, and ease of use of the EyeControl device.

Official Title
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Eye-Control Trial: Wearable Eye-Tracking Device as Means of Communication in the Critically Ill, and Mechanically Ventilated Patient

Conditions
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Acute Respiratory Failure Requiring Mechanical Ventilation

Intervention / Treatment
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* Device: EyeControl Eye-tracking Device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Intensive Care Unit (ICU) Admission Mechanically ventilated for at least 24 hours Richmond Agitation Sedation Score (RASS) between -1 to 1 at the time of screening Ability to follow simple commands Exclusion Criteria: Inability to follow commands during screening (at a minimum: open and close eyes, move eyes to one side or the other). Known cerebral injury (acute or chronic) in the dominant hemisphere concerning for aphasia on clinical assessment Significant pre-existing neurologic (i.e., dementia and/or cognitive deficiencies), psychiatric, or baseline communication challenges that would confound outcomes assessments Inability to blink or move eyes for any reason Prisoner or incarceration Inability or unwillingness to provide informed consent Unwillingness to be contacted for follow-up

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EyeControl Eye-tracking Device<br>Ventilated ICU patients using the EyeControl wearable, eye-tracking device. | Device: EyeControl Eye-tracking Device<br>* The EyeControl is a new, wearable, eye-tracking device that facilitates communication by means of internal feedback to the patients with a bone-conducting speaker. In this way, the device can ask the patient what he or she wants to say, and the patient replies by eye gestures such as blinking or moving the eyes in a certain direction. Once the patient is able to operate the device, it will stay on the patient for as long as she or he would like it on, or until the patient is successfully extubated or discharged from the ICU, whichever is earliest.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time To Successful Operation | The outcome measure for this goal will be the time (in minutes) of training required for a patients to successfully execute two tasks using the device: call for help and choose a predefined sentence for the device to say three times straight. | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of Use | The length of device use, in minutes, will be recorded. | Up to extubation or ICU discharge (up to 5 days, on average) | 
| Type of Use | The type of use will be categorized as use for communication, entertainment, call for help, and other categories, as necessary. | Up to extubation or ICU discharge (up to 5 days, on average) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Critical illness, Communication, Intensive care unit, Mechanical ventilation