Journal of critical care · 2025
A pilot study to assess the safety and feasibility of a wearable communication device in mechanically ventilated critically ill patients.
Клиническое исследованиеСтатьяМногоцентровое исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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Sadan Ofer, Ratcliff Jonathan J, Samuels Owen B, Hall Alex J
Аннотация
INTRODUCTION: Critically ill patients with inability to generate speech due to the presence of an artificial airway suffer from communication challenges. The EyeControl-Med wearable eye-tracking device was designed to overcome this challenge. This pilot study was aimed at demonstrating the safety and feasibility of deploying the EyeControl-Med device in critically ill patients.
METHODS: A prospective pilot, open-label clinical trial was performed in multiple intensive care units (ICU) (medical, surgical, and neuroscience ICU) in a single tertiary hospital. Critically ill patients requiring an artificial airway, unable to produce voice communication, awake (defined as Richmond Agitation Sedation Scale (RASS) score of -1 to 1), and able to follow simple commands were included. The study intervention included wearing a head-mounted device communication device, and operating it using bi-directional communication with the device. The patients were delivered a structured tutorial and followed by proficiency test. Passing the latter served as the primary endpoint.
RESULTS: A total of 30 patients participated in the study. The median (range) age was 52(25-85), and a third were females. The primary outcome was met in 11 patients (36%). In a secondary analysis, 70% of the patients were able to partially operate the device, while not all successfully completed the proficiency test. No serious adverse events were noted.
CONCLUSIONS: The EyeControl communication device can be used for critically ill patients with an artificial airway in a safe manner. Most patients were able to operate elements of the device, and a third were able to complete the pre-defined thorough proficiency test.
METHODS: A prospective pilot, open-label clinical trial was performed in multiple intensive care units (ICU) (medical, surgical, and neuroscience ICU) in a single tertiary hospital. Critically ill patients requiring an artificial airway, unable to produce voice communication, awake (defined as Richmond Agitation Sedation Scale (RASS) score of -1 to 1), and able to follow simple commands were included. The study intervention included wearing a head-mounted device communication device, and operating it using bi-directional communication with the device. The patients were delivered a structured tutorial and followed by proficiency test. Passing the latter served as the primary endpoint.
RESULTS: A total of 30 patients participated in the study. The median (range) age was 52(25-85), and a third were females. The primary outcome was met in 11 patients (36%). In a secondary analysis, 70% of the patients were able to partially operate the device, while not all successfully completed the proficiency test. No serious adverse events were noted.
CONCLUSIONS: The EyeControl communication device can be used for critically ill patients with an artificial airway in a safe manner. Most patients were able to operate elements of the device, and a third were able to complete the pre-defined thorough proficiency test.