Manually Operated Communication System

Completed · Not applicable

Conditions studied: Communication, Ventilation Therapy; Complications

In brief

The objective of this study is to gather initial information about the testing of a novel manual communication system - which is currently called MOCS, for Manually Operated Communicated System - for mechanically ventilated Intensive Care Unit (ICU) subjects. This study is not hypothesis based; the goal is to gather data about which interaction modes and teaching approaches of MOCS are most intuitive for subjects and caregivers.

Key facts

Study ID

NCT03630003

Run by

J. Matthias Walz

People needed

20

Starts

2018-06-28

Expected to finish

2023-04-15

Last updated by the study team

2023-05-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects who are awake with a Glasgow Coma Scale score >10 (Motor 6, Verbal 0-1 [T], Eye opening 4) adult subjects at UMass Medical Center (Memorial and University ICUs) or at MGH (Bigelow 13, Lunder 6, Blake 7, Blake 12, or Ellison 4) are eligible for this study.
• Both subjects who are able to speak and subjects who are unable to speak (due to intubation or tracheostomy) will be sought to be included in the study, although the focus will be on subjects who are unable to speak. (If additional feedback about the system from subjects who can speak would be helpful, this type of subject may be enrolled.)
• Eligible subjects must have a history of being able to understand and communicate in written and spoken English, since the device software is in English.
• May enroll both adults capable of consent and cognitively impaired adults, who will provide assent, if possible, and will have consent given by their legally authorized representative.

You may not qualify if…

• non-adult individuals
• prisoners

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States
• UMass Medical School — Worcester, Massachusetts, United States

Full record on ClinicalTrials.gov

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