Clinical trial NCT04582149: Eye-Control Trial: Wearable Eye-Tracking Device as Means of Communication
Official title: Wearable Eye-Tracking Device as Means of Communication in the Critically Ill and Mechanically Ventilated Patient
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Respiratory Failure Requiring Mechanical Ventilation
Keywords: Critical illness
Communication
Intensive care unit
Mechanical ventilation
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Eyefree Assisting Communication Ltd
First posted: 2020-10-09
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants Who Succeeded in Operating the EyeControl Device
timeFrame: Up to Day 3
measure: Time To Successful Operation of the EyeControl Device
timeFrame: Up to Day 3
measure: Number of Participants Successfully Operating the EyeControl Device Per Attempt Day
timeFrame: Up to Day 3
Secondary outcomes:
measure: Days of Use
timeFrame: Up to end of study participation (up to 3 days)
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
Study officials:
affiliation: Emory University
name: Ofer Sadan, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: