N/A
Completed N=30
Eye-Control Trial: Wearable Eye-Tracking Device as Means of Communication
Acute Respiratory Failure Requiring Mechanical Ventilation
Source: ClinicalTrials.gov NCT04582149 ↗
Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Feb 2024
Primary outcomePrimary: Number of Participants Who Succeeded in Operating the EyeControl Device — 11 Participants
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.
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 | — |
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
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. Informational only — not medical advice.