N/A N=30 Supportive Care

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

Acute Respiratory Failure Requiring Mechanical Ventilation

Bottom Line

View on ClinicalTrials.gov: NCT04582149 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2024

Primary outcome: Primary: Number of Participants Who Succeeded in Operating the EyeControl Device — 11 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: EyeControl Eye-tracking Device (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Emory University
Primary completion: Jan 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants Who Succeeded in Operating the EyeControl Device	11	—
PRIMARY Time To Successful Operation of the EyeControl Device	11	—
PRIMARY Number of Participants Successfully Operating the EyeControl Device Per Attempt Day	8; 3; 0	—
SECONDARY Days of Use	1	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04582149). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.