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

Not Applicable

Completed

Conditions: Acute Respiratory Failure Requiring Mechanical Ventilation

Interventions: Device: EyeControl Eye-tracking Device

Registration Number: NCT04582149

Lead Sponsor: Emory University

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 30

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
EyeControl Eye-tracking Device	EyeControl Eye-tracking Device	Ventilated ICU patients using the EyeControl wearable, eye-tracking device.

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Succeeded in Operating the EyeControl Device	Up to Day 3	Successful operation of the device was defined as completing a set of assignments termed as a proficiency test. This proficiency test included the ability to call for help and the ability to choose a correct answer out of multiple choice questions that were read to the patient using the device. Participants were able to try to learn to operate the device once per day for up to three days.
Number of Participants Successfully Operating the EyeControl Device Per Attempt Day	Up to Day 3	Successful operation of the device was defined as completing a set of assignments termed as a proficiency test. This proficiency test included the ability to call for help and the ability to choose a correct answer out of multiple choice questions that were read to the patient using the device. Participants were able to try to learn to operate the device once per day for up to three days. The study day when participants passed the proficiency test was documented.
Time To Successful Operation of the EyeControl Device	Up to Day 3	Successful operation of the device was defined as completing a set of assignments termed as a proficiency test. This proficiency test included the ability to call for help and the ability to choose a correct answer out of multiple choice questions that were read to the patient using the device. Participants were able to try to learn to operate the device once per day for up to three days. The time (in minutes) of training required for a patient to successfully operate the device was documented.

Secondary Outcome Measures

Name	Time	Method
Days of Use	Up to end of study participation (up to 3 days)	The duration of EyeControl device use and participation in the trial was recorded in days (participation in the trial ended when use of the device ended). Participants left the trial due to inability to operate the device, patient request, technical issues, and no longer needing the device (extubation, ICU discharge).