Status:
COMPLETED
Testing a Novel Manual Communication System for Mechanically Ventilated ICU Patients
Lead Sponsor:
University of Massachusetts, Worcester
Collaborating Sponsors:
Brown University
Conditions:
Communication
Ventilation Therapy; Complications
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The objective of this study is to gather initial information about the testing of a novel manual communication system for mechanically ventilated Intensive Care Unit (ICU) subjects. This phase of the ...
Detailed Description
Intensive Care Unit (ICU) admissions constitute a major part of hospital activity and resource allocation, and the number of patient days in ICUs and on mechanical ventilation is increasing. More than...
Eligibility Criteria
Inclusion
- PHASE 1
- Subjects who are awake, alert, and without clear evidence of delirium (GCS\>13) adult subjects in the Memorial and University ICUs 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.
- Eligible subjects must have a history of being able to understand and communicate in written and spoken English or Spanish.
- Any subject who is capable of consent but cannot speak will provide consent by signing the consent form if possible, with a witness, who is not a member of the research team, present who will sign the appropriate section of the consent form.
- PHASE 2
- Subjects who are awake with a GCS\>10 (Motor 6, Verbal 1, Eye opening 3) adult subjects in the Memorial and University ICUs 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.
- Eligible subjects must have a history of being able to understand and communicate in written and spoken English or Spanish.
- 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.
Exclusion
- PHASE 1/PHASE 2
- Spanish-speaking individuals may be included in the study under the following conditions:
- Spanish interpreter is available in person or by phone for the consent process.
- The consent process is followed as outlined in question 30-31, depending on whether subject is able to speak or not at this time.
- No other non-English-speaking subjects will be included in the study.
- The following vulnerable populations will not be included in the study:
- Pregnant women, non-adult individuals, prisoners.
Key Trial Info
Start Date :
September 6 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 20 2019
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT04105751
Start Date
September 6 2016
End Date
August 20 2019
Last Update
May 1 2023
Active Locations (1)
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1
UMass Medical School
Worcester, Massachusetts, United States, 01655