Testing a Novel Manual Communication System for Mechanically Ventilated ICU Patients

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 for mechanically ventilated Intensive Care Unit (ICU) subjects. This phase of the study is not hypotheses based; the goal is to gather data about which potential form factors and interaction modes of the proposed communication system are most intuitive for subjects and caregivers.

Key facts

Study ID

NCT04105751

Run by

University of Massachusetts, Worcester

People needed

27

Starts

2016-09-06

Expected to finish

2019-08-20

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…

• 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.

You may not qualify if…

• 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.

Where it is running

• UMass Medical School — Worcester, Massachusetts, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.