Brain Computer Interface for Communication in Ventilated Patients

Stopped early · Not applicable

Conditions studied: Mechanical Ventilation, Nonverbal Communication, Intratracheal Intubation, Critical Illness

In brief

Objectives: Specific Aim 1: To demonstrate the feasibility of using a Steady State Visual Evoked Potential (SSVEP) based Brain Computer Interface (BCI) device to facilitate communication of common patient needs in alert mechanically ventilated patients in the Intensive Care Unit (ICU). Specific Aim 2: To determine patient, family and bedside nurse satisfaction with communication using the BCI device and elicit open-ended feedback to guide future device improvements Design: Translational pilot study of a Steady State Visual Evoked Potential (SSVEP) based BCI system to facilitate communication in intubated patients, with sequential use of the BCI device and a picture board. Selection of the primary self-identified primary patient need on the BCI device will be compared to the icon selected on the picture board (reference standard). A patient satisfaction survey will then be provided to the patient or a family member following use for 2 hours a day for 3 consecutive days. Primary outcome: Accurate selection of the illustrative icon on the brain computer interface representing the physical or emotional need self-identified by the patient as being the most common trigger for communication with the bedside nurse during their admission. Secondary outcome: Selection by patients or family of "agree" or "strongly agree" with the statement "The Brain computer interface device allowed me to communicate my needs to the bedside nurse adequately". Intervention: Use of the brain computer device in the ICU for communication for 2 hours a day for 3 consecutive days Control/ Comparator: Sequential use of a communication picture board for 2 hours a day for 3 consecutive days, on the same days that the BCI device is used Sample Size: 30 mechanically ventilated but alert patients in the Intensive Care Unit

Key facts

Study ID

NCT02791425

Run by

University of Michigan

People needed

1

Starts

2017-03-01

Expected to finish

2017-08-25

Last updated by the study team

2019-04-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Admitted to an Intensive Care Unit and on mechanical ventilation for at least 24 hours
• Age 18 years or older
• Able to briskly follow commands
• Unimpaired use of at least one upper limb

You may not qualify if…

• Ongoing respiratory distress, severe pain or other source of obvious discomfort requiring immediate medical or nursing attention
• Severe hemodynamic instability with ongoing need for vasopressor titration or resuscitation
• Known impairment of vision, other than error of refraction with corrective lenses present
• Inability to tolerate interruption of sedation
• Inability to communicate fluently in English
• Need for ongoing EEG monitoring

Where it is running

• University of Michigan Health System — Ann Arbor, Michigan, United States

Full record on ClinicalTrials.gov

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