跳至主要内容
临床试验/NCT02791425
NCT02791425终止不适用

Wearable Brain Computer Interface (BCI) to Assist Communication in Mechanically Ventilated Patients the Intensive Care Unit (ICU)

University of Michigan2 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2017年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
1
试验地点
2
主要终点
BCI device accuracy

研究概览

简要总结

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

详细描述

BACKGROUND

An inability to consistently and effectively communicate their most fundamental physical needs is a major problem for mechanically ventilated ICU patients. Patients rate about 40% of communication sessions as difficult and more than a third of communications about pain as unsuccessful. Nurses initiate about 86% of all communication exchanges as it is typically very difficult for a voiceless ICU patient to initiate communication. Patients in the ICU therefore commonly suffer unrecognized pain and discomfort, feelings of loss of control and insecurity, depersonalization, anxiety, sleep disturbances, fear and frustration. Caregivers also frequently report feeling anxious and frustrated in not being able to adequately assess the needs of their patients. This inability to communicate effectively can lead to the inappropriate use of sedatives and prolongation of time spent on the ventilator, which may then lead to increased ICU length of stay and costs. Furthermore, the inability to communicate with caregivers hampers the ability of critically ill patients to be active participants in their treatment and in decision-making, including decisions to withdraw or withhold life-sustaining treatment.

The use of picture boards with icons representing common patient needs and complaints (pain, fear, hot/ cold, thirst, bedpan etc) has been shown to improve nurse-patient communication for patients in the postoperative period on the ventilator. These picture boards are widely available in most ICUs and are the closest thing to a current standard for communication with voiceless mechanically ventilated patient, for the purposes of addressing fundamental physical and emotional needs. Recent pilot studies have described the use of computer-assisted communication using touch sensitive screens, eye blink detectors and gaze trackers to enable communication in the ICU patient. The majority of patients and hospital staff surveyed in these studies indicated that the use of a computer-assisted communication device improved the ability to respond to patient needs and address patient comfort. Gaze and eye blink tracker systems are expensive, however, while touch sensitive screens may not be suitable for the many ICU patients with weakness and restriction in motor ability. Patients in the ICU, particularly those with neurological illness, frequently suffer from significant weakness and loss of co-ordination, however, limiting their ability to use their arms and hands to indicate the appropriate item on the board. While patients in the neuroICU are frequently weak because of focal brain injury, about a quarter of patients requiring mechanical ventilation in other ICUs may have significant weakness from critical illness neuropathy and myopathy, limiting their ability to use their hands to select the appropriate icon on a picture board. There are several patient populations, however, for whom the use of a picture board or touch screen is impossible, including patients with high spinal cord injury, advanced ALS and brainstem stroke, who are voiceless, but also typically have no useful motor function of their limbs. These patients are "locked-in", to varying degrees, awake and alert but with no control of bodily function or ability to articulate and communicate using standard forms of communication.

The use of Brain Computer Interface (BCI) devices to facilitate communication in "voiceless" patients has recently generated interest. A BCI translates deliberate, voluntary modulation of cerebral electrical activity, typically recorded by electroencephalography (EEG) into computer commands. A variety of BCI devices have been used to permit patients with advanced Amyotrophic Lateral Sclerosis (ALS), high spinal cord injury and brainstem stroke with the locked-in-syndrome, who have no voluntary use of their limbs, to communicate to varying degrees. These devices have typically been evaluated in the rehabilitation setting, following the period of acute medical illness, or at home. No study has evaluated the use of a BCI device to assist with communication of the typical physical and emotional needs/ complaints of the critically ill. This is significant, not only for patients with spinal cord injury and stroke, most of who are initially admitted to an ICU, but to the potentially large number of ICU patients who cannot use a picture board or other finger contact system because of critical illness neuropathy/ myopathy or acute brain injury causing weakness. Our focus is on creating a steady state visual evoked potential (SSVEP) based, wireless BCI system to facilitate communication with intubated ICU patients., The wearable BCI device of interest in this study functions through visual attention to illustrative icons displayed on an electronic screen. The icon, which may depict a common ICU patient need, such the need for repositioning or common patient complaint, such as pain, can be displayed as a symbol. The patient can, thereby, communicate by looking at a specific item depicting their need or complaint. This wearable device is entirely noninvasive and without significant risk to patients, functioning only to record and translate EEG signals. The device will communicate wirelessly with the user interface (UI) that can be either a tablet or the flat screen TV monitor that is present in every ICU patient room. The proposed prototype provides a user interface that includes basic functions that are typically used in communication between nurses and patients in the ICU.

STUDY DESIGN

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Brain Computer Interface (BCI) device

Experimental

The patient uses the Brain Computer Interface (BCI) device in the ICU for communication for 2 hours a day for 3 consecutive days. 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.

干预措施: Brain Computer Interface (BCI) device (Device)

Brain Computer Interface (BCI) device

Experimental

The patient uses the Brain Computer Interface (BCI) device in the ICU for communication for 2 hours a day for 3 consecutive days. 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.

干预措施: Communication picture board (Other)

结局指标

主要结局

BCI device accuracy

时间窗: Immediately following enrollment

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.

次要结局

  • Satisfaction survey(At the end of 3 days of using BCI device)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Venkatakrishna Rajajee

Clinical Associate Professor, Neurosurgery and Neurology Medical Director, Neurointensive Care

University of Michigan

研究点 (2)

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