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CTSI-iPad for Vented Patient Communication

A Randomized Controlled Trial of an iPad for Patient Communication During Mechanical Ventilation

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03163823
Acronym
iPad
Enrollment
21
Registered
2017-05-23
Start date
2017-02-23
Completion date
2020-09-21
Last updated
2021-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Failure

Brief summary

This study will enroll 75 mechanically vented adults in the ICU to compare self-reported ease of communication, patient satisfaction, and patient anxiety and frustration levels between a group using a communication application on an iPad and a group using standard methods of communication while mechanically vented.

Detailed description

The Investigators will randomize patients to either an iPad application available for communication or usual care. An existing iPad communication application (Proloquo2Go) that allows picture or text to voice communication was tailored to needs of adult mechanically ventilated (MV) patient. In the tailored application, common messages for an adult MV population are depicted on picture tiles organized into folders. When patients touch a picture tile either additional message options appear or a phrase or word is spoken by the device. Access to a pop-up keyboard on each screen allows patients to easily type unique text to voice messages. Intervention: Patients will be randomized to either an iPad with the tailored communication application or usual care. Patients randomized to the iPad group will be given a brief introduction to the communication application and then will be asked to communicate four messages to verify understanding. Patients who are unable to successfully use the iPad with the initial introduction will remain in the study. Research staff will continue to assist the patient daily and a speech language pathologist will be consulted to facilitate the patients ability to use the device. The iPad will remain at the bedside to be used for communication as desired for the remainder of the time the patient is on the ventilator. A manual providing instruction for the iPad and application operation will be at the bedside of all patients randomized to the intervention group. Research staff will visit patients daily to assist with any problems encountered and will also be available by phone to assist as needed. Although patients will be encouraged to use the iPad for communication, use of other strategies or tools will not be restricted.

Interventions

OTHERProloquo2Go

Use of communication application Proloquo2Go modified for the ICU setting on an iPad device

OTHERStandard of Care

Standard of Care communication methods

Sponsors

Marquette University
CollaboratorOTHER
Medical College of Wisconsin
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Sufficient motor and visual function to allow use of touch screen 2. Mechanically ventilated 3. Awake and able to participate in informed consent discussion

Exclusion criteria

1. Non-English Speaking 2. Receiving ventilator support prior to admission. 3. Delirium present in the last 24 hours 4. Tracheostomy 5. Structural Neurological Injury (such as stroke or traumatic brain injury) 6. Coma 7. Deep Sedation (Richmond Agitation Scale \> -2)

Design outcomes

Primary

MeasureTime frameDescription
Ease of Communication30 DaysPatient self-reported ease of communication during mechanical ventilation measured using a Likert scale

Secondary

MeasureTime frameDescription
Patient Anxiety30 DaysPatient Anxiety while Mechanically Ventilated in an ICU measured by VAS anxiety
Patient Satisfaction30 DaysMechanically ventilated ICU patient satisfaction with device measured using a Likert scale

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026