Comparative Analysis of Communication Board and Eye Tracking in Intensive Care Mechanically Ventilated Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- State of the art questionnaire - communication difficulties related to mechanical ventilation as experienced by healthcare professionals.
研究概览
简要总结
This prospective study consisted of (1) a descriptive cross-sectional part describing communication difficulties related to mechanical ventilation as experienced by intensive care professionals and patients, and (2) an experimental randomized crossover part comparing the use of a conventional low-tech communication board and a high-tech eye tracking technology-based device to improve communication effectiveness of intensive care mechanically ventilated patients.
详细描述
Sample size:
The health professionals sample size is estimated by convenience to 100 professionals based on the accessible population in the study site (i.e., 95% of the health professionals from the study site). The patients sample size is estimated to 44 patients based on statistical calculation (with a type 1 error rate of 5%, a type 2 error rate of 10% and an allocation ratio of 1), including two groups of 22 patients.
Intervention:
The cross-sectional part involved the healthcare professionals through the "state of the art questionnaire" and the patients through the "ease of communication scale". The crossover part then randomized the patients from the cross-sectional part into two groups and the communication interfaces were divided into two time periods: group A received eye tracking/communication board sequence and group B received communication board/eye tracking sequence. For each period, the communication interfaces were evaluated through the "intervention form". The communication board provides simple messages based on orthographic and iconic content. The eye tracking computer-based system enables the production and construction of simple or complex messages (including word processing with spelling suggestions and voice synthesis), also based on orthographic and iconic content.
Statistical analysis:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 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
- 否
入选标准
- •healthcare professionals:
- •Working in the intensive care unit (study site).
排除标准
- •healthcare professionals:
- •Lack of consent.
- •Inclusion Criteria - patients:
- •Being hospitalized in the intensive care unit (study site),
- •Awake with a Richmond Agitation-Sedation Scale (RASS) between "restless" (+1) and "drowsy" (-1),
- •Age of 18 years or older,
- •French speaker.
- •Exclusion Criteria - patients:
- •Lack of consent,
- •Severe visual impairment (e.g., blindness).
研究组 & 干预措施
Communication board
The communication board consists of a printed paper interface with a size of 42 x 30 cm.
干预措施: Comparison between communication board and eye tracking (Device)
Eye tracking
The eye tracking device combines a laptop computer with a screen size of 29 x 16 cm, an eye tracker (PCEye Mini, Tobii dynavox, Danderyd, Sweden), an interface generated by a communication software (Communicator 5, Tobii dynavox) and a telescopic support.
干预措施: Comparison between communication board and eye tracking (Device)
结局指标
主要结局
State of the art questionnaire - communication difficulties related to mechanical ventilation as experienced by healthcare professionals.
时间窗: Before the use of communication interfaces.
Self-administered questionnaire assessing the difficulties to communicate with intubated or tracheostomized patients, the avoidance of interactions with patients, the perception of the help that could be provided by alternative communication systems and the interest in learning to use these systems.
Quantity of messages transmitted through the communication board.
时间窗: During the use of communication interfaces.
Communication effectiveness indicator, collected through the intervention form.
Success rate for the eye tracking.
时间窗: During the use of communication interfaces.
Communication effectiveness indicator, collected through the intervention form.
Level of satisfaction for the communication board.
时间窗: During the use of communication interfaces.
Communication effectiveness indicator, collected through the intervention form.
Communication content for the eye tracking.
时间窗: During the use of communication interfaces.
Communication effectiveness indicator, collected through the intervention form.
Difficulties of use related to the eye tracking.
时间窗: During the use of communication interfaces.
Communication effectiveness indicator, collected through the intervention form.
Ease of communication scale (ECS) - communication difficulties related to mechanical ventilation as experienced by patients.
时间窗: Before the use of communication interfaces.
Multidimensional scale completed through an assisted interview and covering the difficulty to be understood; to communicate physical needs, thoughts, and feelings with notably relatives, nurses and physicians; and to ask questions about care and health status.
Level of satisfaction for the eye tracking.
时间窗: During the use of communication interfaces.
Communication effectiveness indicator, collected through the intervention form.
Communication content for the communication board.
时间窗: During the use of communication interfaces.
Communication effectiveness indicator, collected through the intervention form.
Quantity of messages transmitted through the eye tracking.
时间窗: During the use of communication interfaces.
Communication effectiveness indicator, collected through the intervention form.
Success rate for the communication board.
时间窗: During the use of communication interfaces.
Communication effectiveness indicator, collected through the intervention form.
Difficulties of use related to the communcation board.
时间窗: During the use of communication interfaces.
Communication effectiveness indicator, collected through the intervention form.
次要结局
未报告次要终点
研究者
Emilie Szymkowicz
ICU nurse
University of Liege