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

Acute Respiratory Failure Requiring Mechanical Ventilation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04582149
• Other study ID #: IRB00114955
• Status: Completed
• Phase: N/A
• Start date: May 19, 2021
• Est. completion date: January 23, 2023

Study information

• Verified date: January 2024
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 23, 2023
• Est. primary completion date: January 23, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Respiratory Failure Requiring Mechanical Ventilation
• Respiratory Insufficiency

Intervention

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.

Locations

Country	Name	City	State
United States	Emory University Hospital	Atlanta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	Eyefree Assisting Communication Ltd

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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)