Dolores One: Maximizing Functional Communication for Adults Using Non-Invasive Ventilation in the Acute Care Setting
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Change in the Easy of Communication Scale
研究概览
简要总结
Difficulties with communication for patients requiring mechanical ventilation is known to be a source of distress in the acute care setting. The inability to speak has been associated with increased psychological distress and increased feelings of fear and anger and impact negatively on patient participation with caregivers and their overall recovery. Developing and maintaining communication between patients and hospital staff reduces patient stress and increases patient satisfaction and part of the standard pf care. According to the new and revised The Joint Commission standards, hospitals must identify and document patients' communication needs and communicate with patients during their care in a manner that meets those needs. Using the Dolores One device for patients can improve the ease and efficiency of communication while they are in the acute care setting.
For non-speaking patients, nonverbal communication means are often used, including mouthing words and head nods to indicate yes/no responses. However, relying completely on nonverbal means can limit patient responses and lead to ineffective and frustrating communication exchanges. There have been several studies reviewing the negative effects of the inability to speak for intubated, mechanically ventilated patients. However, there is a need for more research to address communication difficulties in other mechanically ventilated populations, including patients receiving non-invasive ventilation and ventilator dependent tracheostomy patients.
The Dolores One is comprised of an acoustic throat sensor and positioned at the patient's neck with a soft adjustable collar. The sensor gathers vocal cord vibrations and transmits signals to a control unit, processes the sensor signal, and finally, generates the patient's voice. The smart signal processing automatically accommodates both weak forced voices and whispers, producing a voice output to allow for normal conversation in a patient's natural voice, free from the sounds of rushing air or equipment noises secondary to Non-Invasive Mechanical Ventilation (NIMV) systems.
The purpose of the study is to determine if the Dolores One devices can be used in the clinical acute care setting with patients in NIMV to improve their ability to communication as measured as ease to communicate and intelligibility, with family and the members of the medical team.
详细描述
Primary Aims:
- Is to determine if the Dolores One device can significantly improve the ease of communication as measured by the Ease of Communication
- Is to determine if the Dolores One device can significantly improve the intelligibility of communication as measured by the Intelligibility section of the Frenchay Dysarthria Assessment (FDA).
Design:
This study will be a prospective study using a convenient cohort of 55 adult patients, who was using NIMV, to pilot the effectiveness of the Dolores One to improve verbal communication. There will be no randomization and no control group. The design is a pretest / posttest mixed method in which the Easy of Communication Scale and the Intelligibility section of the FDA will be administered at base line and repeated once the Dolores One has been set up on the patient.
Methodology:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Requires NIMV
- •Uses a full face mask
- •Using a University of Maryland Medical Center (UMMC) device
- •Medically stable as determined by the medical team (register nurse (RN) and licensed independent provider)
- •The patient is stable on NIMV which measure same settings for a period 30 to 90 minutes as per RT guidelines
- •Glasgow Coma Scale (GCS) 15
- •Subjects speak English
- •Skin is intact in the area where the Dolores One would be placed.
排除标准
- •Patient is unable to consent self for the study
- •Pre-existing speech, language, voice or cognitive deficits
- •NIMV setting that exceeds the following prescription: FIO2 > .60; Peep > 12 mmHg, inspiratory pressure > 15 mmHg
结局指标
主要结局
Change in the Easy of Communication Scale
时间窗: Testing is at baseline, and 24-36 hours after use of the Dolores One
Easy of Communication Scale is a self reported 10 item questionnaire where the subjects rate their perception of the ease to communicate. It is scored on a 5 point likert scale (0 to 4) with a range of 0-40. The investigators are examining the change in communication without and with the use of the Dolores One device. The higher the score the more difficulty the subject perceives it is to communicate with other.
Change in the Intelligibility Subscale of the Frenchay Dysarthria Assessment Tool
时间窗: Testing is at baseline and 24 to 36 hours after use of the Dolores One
The Intelligibility Score is a subscale of the Frenchay Dysarthria Assessment Tool that examines motor speech deficits. The Intelligibility Subscales examines the precision of articulation. This subscale involves the subject speaking 5 randomized short phrases and the intelligibility is scored as a yes / no based upon accuracy of a volunteer repeating the phrase accurately. The subscale has a range of 0-5 with 5 being normal and has a minimally detectable change of 1 being significant.
次要结局
未报告次要终点
研究者
Chris Wells
EBP & Research Coordinator
University of Maryland, Baltimore
