Brain Computer Interface for Communication in Ventilated Patients

Summary

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

Conditions

• Mechanical Ventilation
• Nonverbal Communication
• Intratracheal Intubation
• Critical Illness

Interventions

DEVICE

Brain Computer Interface (BCI) device

A BCI system to facilitate communication in intubated patients. Patients use the device in the ICU for communication for 2 hours a day for 3 consecutive days.

OTHER

Communication picture board

The patient then uses a communication picture board for 2 hours a day for 3 consecutive days on the same days that the BCI device is used for comparison.

Sponsors & Collaborators

• Michigan Institute for Clinical and Health Research (MICHR)

  collaborator UNKNOWN

• University of Michigan

  lead OTHER

Principal Investigators

• Omid Dehzanghi, PhD · University of Michigan

Study Design

Allocation

NA

Purpose

OTHER

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-03-01

Primary Completion

2017-08-25

Completion

2017-08-25

Countries

• United States

Study Locations