Testing a Novel Manual Communication System for Mechanically Ventilated ICU Patients

NCT04105751 | Completed FDA Device

• 1 other identifier: H00010101
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Communication; Ventilation Therapy; Complications

Outcome Measures

Primary Outcomes (1)

• Ability of user to make one or more selections in the software

  Whether the user is able to make one or more selections in the software will be evaluated.

  1 hour

Secondary Outcomes (1)

• Duration of use

  1 hour

Study Arms (1)

Use of Device with post-use interview/questionnaire

EXPERIMENTAL

All patients will be asked to utilize device and will then be asked to provide feedback on their experiences. This may be done by interview or a questionnaire. There could be up to three sessions using the device. Each session is expected to last between 10 and 30 minutes. If the subject is interested in continuing, session could last up to one hour.

Device: Novel Communication System

Interventions

Novel Communication System DEVICE

Small hand held device that aids in answering questions. Used in conjunction with a tablet computer.

Use of Device with post-use interview/questionnaire

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• University of Massachusetts, Worcester: lead
• Brown University: collaborator

Study Sites (1)

UMass Medical School

Worcester, Massachusetts, 01655, United States

Location

MeSH Terms

Conditions

Communication

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• J. Matthias Walz, MD

  UMass Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Interim Chair, Dept of Anesthesiology and Perioperative Medicine

Study Record Dates

• First Submitted: August 24, 2019
• First Posted: September 26, 2019
• Study Start: September 6, 2016
• Primary Completion: August 20, 2019
• Study Completion: August 20, 2019
• Last Updated: May 1, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)