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

Wearable Eye-Tracking Device as Means of Communication in the Critically Ill and Mechanically Ventilated Patient

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.

Study Overview

• Status: Completed
• Conditions: Acute Respiratory Failure Requiring Mechanical Ventilation
• Intervention / Treatment: Device: EyeControl Eye-tracking Device

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ofer Sadan, MD, PhD; Phone Number: 470-480-6956; Email: ofer.sadan@emory.edu

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: EyeControl Eye-tracking Device; Ventilated ICU patients using the EyeControl wearable, eye-tracking device.

Device: EyeControl Eye-tracking Device; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Who Succeeded in Operating the EyeControl Device	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.	Up to Day 3
Time To Successful Operation of the EyeControl Device	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.	Up to Day 3
Number of Participants Successfully Operating the EyeControl Device Per Attempt Day	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.	Up to Day 3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Days of Use	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).	Up to end of study participation (up to 3 days)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wakefulness Monitoring	The device will record the times in which the patient is awake by monitoring when the patient's eyes are open. This data will later be correlated with outcome measures such as delirium, length of stay, and functional outcome.	Up to extubation or ICU discharge (up to 5 days, on average)
Confusion Assessment Method in Intensive Care Unit (CAM-ICU) Validation	The CAM-ICU will be administered by ICU nurses as standard of care and the examination will be repeated using the device by using multiple-choice questions and asking the patient to choose the correct answers by blinking. Correlation between the responses between collected by nurses and with the device will be assessed.	Up to extubation or ICU discharge (up to 5 days, on average)

Collaborators and Investigators

• Sponsor: Emory University
• Collaborators: Eyefree Assisting Communication Ltd
• Investigators: Principal Investigator: Ofer Sadan, MD, PhD, Emory University

Study record dates

Study Major Dates

• Study Start (Actual): May 19, 2021
• Primary Completion (Actual): January 23, 2023
• Study Completion (Actual): January 23, 2023

Study Registration Dates

• First Submitted: October 5, 2020
• First Submitted That Met QC Criteria: October 5, 2020
• First Posted (Actual): October 9, 2020

Study Record Updates

• Last Update Posted (Estimated): February 14, 2024
• Last Update Submitted That Met QC Criteria: January 23, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Intensive care unit; Critical illness; Communication; Mechanical ventilation
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• Other Study ID Numbers: IRB00114955

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie results reported in the study publications (text, tables, figures, and appendices) will be available for sharing with other researchers, after deidentification.
• IPD Sharing Time Frame: Individual participant data will be available for sharing beginning one year after article publication, with no end date.
• IPD Sharing Access Criteria: Non-study investigators and researchers (i.e., external) may submit their proposal to the study investigators for approval of methodologically appropriate proposals and inquiry. Data will be available for sharing in order to achieve aims in the approved proposal. Proposals should be submitted to the PI at ofer.sadan@emory.edu. Requestors will be required to execute a data use/transfer agreement to receive a limited dataset. Data will be provided directly to external investigators.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes