EyeControl Communication Device for ICU Delirium

(EMERGE Trial)

Recruiting at 2 trial locations

Overseen By Van Nguyen, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Beth Israel Deaconess Medical Center

Must not be taking: Neuromuscular blockers

Disqualifiers: Advanced dementia, Neurological disorders, Psychiatric disorders, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 7 days

160 Participants Needed

Trial Summary

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the EyeControl communication device treatment for ICU delirium?

Research suggests that eye-tracking devices, like the EyeControl-Med, can improve communication for patients in the ICU who cannot speak, potentially reducing anxiety and frustration that may contribute to delirium. These devices allow patients to communicate through eye movements, which can help them express their needs and reduce feelings of isolation. ^{1 2 3 4 5}

Is the EyeControl Communication Device safe for use in humans?

The available studies on eye-tracking devices, including the EyeControl-Med, focus on improving communication for ICU patients but do not report any specific safety concerns, suggesting they are generally safe for use in humans. ^{1 4 5 6 7}

How does the EyeControl Communication Device differ from other treatments for ICU delirium?

The EyeControl Communication Device is unique because it uses eye movements to help ventilated ICU patients communicate, potentially reducing anxiety and frustration that can lead to delirium. Unlike traditional methods, this device allows patients to interact through audio content and eye-tracking, offering a novel way to address communication challenges in critically ill patients. ^{1 2 4 5 6}

What is the purpose of this trial?

The purpose of this research is to investigate whether addition of the EyeControl-Pro platform as an adjunct to standard guideline-based intensive care unit management of critically ill patients is effective in reducing delirium incidence and severity.

Research Team

Somnath Bose, MD

Principal Investigator

Beth Israel Deaconess Medical Center

Eligibility Criteria

This trial is for critically ill patients aged 50 or older who are expected to need a ventilator for at least 24 hours and can respond minimally. They shouldn't be in another conflicting study, have severe cognitive impairments, uncorrected hearing or vision issues, or conditions limiting survival or care directives.

Inclusion Criteria

Your RASS score is between -3 and +1.

You are expected to need a ventilator for at least 24 hours.

I am 50 years or older and on a mechanical ventilator.

Exclusion Criteria

It is not expected that you will live for at least 24 hours.

Have severe uncorrected psychiatric disorders

Enrolled in a clinical trial which prohibits co-enrollment

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Treatment

Participants receive either the EyeControl-Pro device or a sham device for up to 7 days while in the ICU

7 days

Daily assessments (in-person)

Follow-up

Participants are monitored for cognitive function and anxiety/depression scores 30 days post-randomization

30 days

1 visit (in-person or virtual)

Treatment Details

Interventions

• EyeControl-Pro

Trial Overview The EMERGE trial is testing if the EyeControl-Pro platform helps reduce how often and how severely delirium occurs in ICU patients when added to standard care. Patients will either use the new device (EyeControl-Pro) or receive usual care without it.

Participant Groups

Group I: EyeControl-Pro assisted active intervention arm Active Control 1 Intervention

The device will be placed on patient's heads. Once the device is properly positioned, patient's will undergo a training session/tutorial lasting 2-3 minutes to orient them to the device usage. Personalized family messages recorded by LARs or others will be played at regular intervals up to 5 times per day (between 08:00-18:00) (8 am to 6 pm). Personalized music/brown noise will be played for 15 minutes every 4 hours, which will be modulated according to your reactions/choices. A study team member will assess patient's mental status by asking thinking and memory questions twice a day (AM and PM). The device will perform the same assessments within 30 minutes of those performed by the study team. The device will be removed at 1800/2000 hrs to ensure adequate sleep. Patient's will be in this study arm for up to 7 days of start of study. The device will be removed on day 7 or sooner if patient's do not need ventilator support and standard care will continue as before device usage.

Group II: Sham Control Placebo Group 1 Intervention

The device will be placed on patient's heads. Once the device is properly positioned, patient's will undergo a training session/tutorial lasting 2-3 minutes to orient them to the device usage. Patient's will not receive any of the orientation or family messages and no music will be played through the earphones of the device. A study team member will assess patient's mental status by asking thinking and memory questions twice a day (AM and PM). The device will perform the same assessments within 30 minutes of those performed by the study team. The device will be removed at 1800/2000 hrs to ensure adequate sleep. Patient's will be in this study arm for up to 7 days of start of study. The device will be removed on day 7 or sooner if patient's do not need ventilator support and standard care will continue as before device usage.

Who Is Running the Clinical Trial?

Beth Israel Deaconess Medical Center

Lead Sponsor

Trials

872

Recruited

12,930,000+

Assuta Medical Center

Collaborator

Trials

43

Recruited

44,700+

Rabin Medical Center

Collaborator

Trials

423

Recruited

149,000+

BIRD (Israel-United States Binational Industrial Research and Development) Foundation- Funding agency

Collaborator

Trials

1

Recruited

160+

Eyefree Assisting Communication Ltd

Industry Sponsor

Trials

3

Recruited

210+

Findings from Research

Patients in the ICU who used eye-tracking devices were able to effectively communicate their basic needs, indicating that these devices can enhance communication in critical care settings.

The use of eye-tracking devices led to significant improvements in patients' psychosocial status, with a positive overall impact score on the Psychosocial Impact of Assistive Devices Scale (PIADS), suggesting potential benefits for patient outcomes in the ICU.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot study of eye-tracking devices in intensive care. Garry, J., Casey, K., Cole, TK., et al.[2022]

In a study involving 11 mechanically ventilated patients, eye-tracking technology was successfully learned and used for communication within an average of 64 minutes, allowing patients to express their needs and answer questions about their condition.

All patients preferred the gaze fixation method over the wink control for operating the eye-tracking device, indicating a user-friendly approach that enhances communication and may improve rehabilitation outcomes by allowing for better detection of complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First experiences of communication with mechanically ventilated patients in the intensive care unit using eye-tracking technology. Ull, C., Weckwerth, C., Schildhauer, TA., et al.[2023]

In a study involving 44 mechanically ventilated patients, the high-tech eye tracking device significantly improved communication effectiveness compared to a conventional low-tech communication board, with patients transmitting a median of four messages per exchange versus two for the board.

The eye tracking device also had a higher success rate (100% vs. 80%) and greater patient satisfaction (52% satisfied and 48% very satisfied) compared to the board, indicating its potential to enhance patient-centered care in intensive care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of communication interfaces for mechanically ventilated patients in intensive care. Szymkowicz, E., Bodet-Contentin, L., Marechal, Y., et al.[2023]

The study involved 15 dysarthric ICU patients, 8 physicians, and 15 nurses, and found that using a gaze-controlled communication system (eye tracker) significantly improved communication between patients and medical staff across various domains, including understanding patient needs and clinical conditions.

Post-intervention results indicated a notable reduction in anxiety and frustration for both patients and healthcare providers, suggesting that enhanced communication can positively impact psychological well-being in the ICU setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gaze-controlled, computer-assisted communication in Intensive Care Unit: "speaking through the eyes". Maringelli, F., Brienza, N., Scorrano, F., et al.[2022]

In a pilot study involving 15 critically ill patients, the EyeControl-Med device significantly improved communication capabilities, as indicated by a mean increase of 19.3 points on the Loewenstein Communication Scale (p < 0.0001).

The use of the EyeControl-Med device also correlated with a reduction in delirium symptoms, with the mean number of errors on the CAM-ICU questionnaire decreasing from 6.5 to 2.5 (p = 0.0006), and no adverse effects were reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The EyeControl-Med device, an alternative tool for communication in ventilated critically ill patients: A pilot study examining communication capabilities and delirium. Itai Bendavid, I., Assi, S., Sasson, N., et al.[2023]

In a pilot study involving 12 mechanically ventilated patients in a surgical ICU, both a communication board (CB) and an eye tracking device (ETD) were found to be equally effective in helping patients communicate their basic needs, achieving 100% accuracy.

A significant 83% of patients expressed a desire to communicate additional needs beyond basic questions, highlighting the importance of using assistive communication devices to uncover a wider range of patient concerns, including emotional and spiritual needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot study assessing the spiritual, emotional, physical/environmental, and physiological needs of mechanically ventilated surgical intensive care unit patients via eye tracking devices, head nodding, and communication boards. Duffy, EI., Garry, J., Talbot, L., et al.[2022]

This pilot study involving 20 intubated ICU patients suggests that the Deltascan single-channel EEG may provide additional insights into detecting delirium, although it did not show statistically significant agreement with the CAM-ICU assessment.

The Deltascan measurements showed a higher, yet not statistically significant, agreement with clinical diagnoses of delirium made by ICU physicians, indicating potential value for further research in larger studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison Between Deltascan Single Channel Electroencephalography (EEG), Confusion Assessment Method-Intensive Care Unit (CAM-ICU) Score and Clinical Assessment in Diagnosing Delirium in Intubated Patients in the Intensive Care Unit. Aben, J., Pouwels, S., Oldenbeuving, A.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

A pilot study of eye-tracking devices in intensive care. [2022]

2. England pubmed.ncbi.nlm.nih.gov

First experiences of communication with mechanically ventilated patients in the intensive care unit using eye-tracking technology. [2023]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Comparison of communication interfaces for mechanically ventilated patients in intensive care. [2023]

4. Italy pubmed.ncbi.nlm.nih.gov

Gaze-controlled, computer-assisted communication in Intensive Care Unit: "speaking through the eyes". [2022]

5. United States pubmed.ncbi.nlm.nih.gov

The EyeControl-Med device, an alternative tool for communication in ventilated critically ill patients: A pilot study examining communication capabilities and delirium. [2023]

6. England pubmed.ncbi.nlm.nih.gov

A pilot study assessing the spiritual, emotional, physical/environmental, and physiological needs of mechanically ventilated surgical intensive care unit patients via eye tracking devices, head nodding, and communication boards. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Comparison Between Deltascan Single Channel Electroencephalography (EEG), Confusion Assessment Method-Intensive Care Unit (CAM-ICU) Score and Clinical Assessment in Diagnosing Delirium in Intubated Patients in the Intensive Care Unit. [2022]