Acute Respiratory Failure Requiring Mechanical Ventilation
Conditions
Keywords
Critical illness, Communication, Intensive care unit, Mechanical ventilation
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.
Interventions
DEVICEEyeControl 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.
Sponsors
Eyefree Assisting Communication Ltd
Emory University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Succeeded in Operating the EyeControl Device | Up to Day 3 | 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. |
| Time To Successful Operation of the EyeControl Device | Up to Day 3 | 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. |
| Number of Participants Successfully Operating the EyeControl Device Per Attempt Day | Up to Day 3 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Days of Use | Up to end of study participation (up to 3 days) | 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). |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from Emory University Hospital in Atlanta, Georgia, USA. Participant enrollment began May 19, 2021 and all study assessments were completed by January 23, 2023.
Participants by arm
| Arm | Count |
|---|---|
| EyeControl Eye-tracking Device Ventilated ICU patients using the EyeControl wearable, 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. | 30 |
| Total | 30 |
Baseline characteristics
| Characteristic | EyeControl Eye-tracking Device |
|---|---|
| Age, Continuous | 52 years |
| Body Mass Index (BMI) | 28.7 kg/m^2 STANDARD_DEVIATION 8.5 |
| Experienced delirium during admission | 12 Participants |
| ICU Type Medical | 13 Participants |
| ICU Type Neuroscience | 5 Participants |
| ICU Type Surgical | 12 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 16 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 12 Participants |
| Region of Enrollment United States | 30 Participants |
| Sequential Organ Failure Assessment (SOFA) Score at Admission | 6 score on a scale |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 30 |
| other Total, other adverse events | 1 / 30 |
| serious Total, serious adverse events | 0 / 30 |
Outcome results
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.
Time frame: Up to Day 3
Population: The population in this analysis includes the 11 participants who were able to successfully operate the device.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| EyeControl Eye-tracking Device | Number of Participants Successfully Operating the EyeControl Device Per Attempt Day | Day 1 | 8 Participants |
| EyeControl Eye-tracking Device | Number of Participants Successfully Operating the EyeControl Device Per Attempt Day | Day 2 | 3 Participants |
| EyeControl Eye-tracking Device | Number of Participants Successfully Operating the EyeControl Device Per Attempt Day | Day 3 | 0 Participants |
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.
Time frame: Up to Day 3
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| EyeControl Eye-tracking Device | Number of Participants Who Succeeded in Operating the EyeControl Device | 11 Participants |
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.
Time frame: Up to Day 3
Population: The population in this analysis includes the 11 participants who were able to successfully operate the device.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EyeControl Eye-tracking Device | Time To Successful Operation of the EyeControl Device | 11 minutes | Standard Deviation 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).
Time frame: Up to end of study participation (up to 3 days)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| EyeControl Eye-tracking Device | Days of Use | 1 days |
Post Hoc
Age of Participants Who Passed or Did Not Pass The Proficiency Test
Participants were stratified based on whether or not they passed the proficiency test and were able to successfully operate the EyeControl device. The mean age at admission of these groups of participants was compared.
Time frame: Up to Day 3
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EyeControl Eye-tracking Device | Age of Participants Who Passed or Did Not Pass The Proficiency Test | 51.9 years | Standard Deviation 15.2 |
| Did Not Pass Proficiency Test | Age of Participants Who Passed or Did Not Pass The Proficiency Test | 50.4 years | Standard Deviation 14.8 |
Post Hoc
Clinical Characteristics of Participants Who Passed or Did Not Pass The Proficiency Test
Participants were stratified based on whether or not they passed the proficiency test and were able to successfully operate the EyeControl device. Clinical characteristics (tracheostomy, delirium, and exposure to certain medications) of these groups of participants were examined.
Time frame: Up to Day 3
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| EyeControl Eye-tracking Device | Clinical Characteristics of Participants Who Passed or Did Not Pass The Proficiency Test | Exposure to fentanyl on day of attempt to use device | 2 Participants |
| EyeControl Eye-tracking Device | Clinical Characteristics of Participants Who Passed or Did Not Pass The Proficiency Test | Exposure to dexmedetomidine on day of attempt to use device | 6 Participants |
| EyeControl Eye-tracking Device | Clinical Characteristics of Participants Who Passed or Did Not Pass The Proficiency Test | Delirium detected on day of device use | 1 Participants |
| EyeControl Eye-tracking Device | Clinical Characteristics of Participants Who Passed or Did Not Pass The Proficiency Test | Exposure to propofol on day of attempt to use device | 0 Participants |
| EyeControl Eye-tracking Device | Clinical Characteristics of Participants Who Passed or Did Not Pass The Proficiency Test | Exposure to any benzodiazepine on day of attempt to use device | 0 Participants |
| EyeControl Eye-tracking Device | Clinical Characteristics of Participants Who Passed or Did Not Pass The Proficiency Test | Exposure to any pressors on day of attempt to use device | 4 Participants |
| EyeControl Eye-tracking Device | Clinical Characteristics of Participants Who Passed or Did Not Pass The Proficiency Test | Tracheostomy | 3 Participants |
| Did Not Pass Proficiency Test | Clinical Characteristics of Participants Who Passed or Did Not Pass The Proficiency Test | Exposure to any pressors on day of attempt to use device | 3 Participants |
| Did Not Pass Proficiency Test | Clinical Characteristics of Participants Who Passed or Did Not Pass The Proficiency Test | Tracheostomy | 8 Participants |
| Did Not Pass Proficiency Test | Clinical Characteristics of Participants Who Passed or Did Not Pass The Proficiency Test | Delirium detected on day of device use | 3 Participants |
| Did Not Pass Proficiency Test | Clinical Characteristics of Participants Who Passed or Did Not Pass The Proficiency Test | Exposure to fentanyl on day of attempt to use device | 6 Participants |
| Did Not Pass Proficiency Test | Clinical Characteristics of Participants Who Passed or Did Not Pass The Proficiency Test | Exposure to any benzodiazepine on day of attempt to use device | 1 Participants |
| Did Not Pass Proficiency Test | Clinical Characteristics of Participants Who Passed or Did Not Pass The Proficiency Test | Exposure to dexmedetomidine on day of attempt to use device | 7 Participants |
| Did Not Pass Proficiency Test | Clinical Characteristics of Participants Who Passed or Did Not Pass The Proficiency Test | Exposure to propofol on day of attempt to use device | 2 Participants |
Post Hoc
SOFA Score of Participants Who Passed or Did Not Pass The Proficiency Test
Participants were stratified based on whether or not they passed the proficiency test and were able to successfully operate the EyeControl device. The Sequential Organ Failure Assessment (SOFA) Score at admission of these groups of participants was compared. The SOFA score is a mortality prediction score that is based on the degree of dysfunction of 6 organ systems (respiratory, nervous, cardiovascular, liver, coagulation, and kidneys). Each organ system is scored on a 5-point scale where normal = 0 and high degree of disfunction = 4. The total score ranges from 0 to 24 and a higher score indicating greater severity. A score of 0-6 is associated with a mortality rate of less than 10% while a score between 16 and 24 is associated with a greater than 90% mortality rate.
Time frame: Up to Day 3
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| EyeControl Eye-tracking Device | SOFA Score of Participants Who Passed or Did Not Pass The Proficiency Test | 7 score on a scale |
| Did Not Pass Proficiency Test | SOFA Score of Participants Who Passed or Did Not Pass The Proficiency Test | 4 score on a scale |