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Completed

NCT Number: NCT03163823

CTSI-iPad for Vented Patient Communication

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Froedtert Memorial Lutheran Hospital

Milwaukee, Wisconsin, 53226, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Proloquo2Go

Other

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

Standard of care

Other

Standard of Care communication methods

Primary outcomes

  1. Ease of Communication

    Time frame: 30 Days

    Patient self-reported ease of communication during mechanical ventilation measured using a Likert scale

Secondary outcomes

  1. Patient Anxiety

    Time frame: 30 Days

    Patient Anxiety while Mechanically Ventilated in an ICU measured by VAS anxiety

  2. Patient Satisfaction

    Time frame: 30 Days

    Mechanically ventilated ICU patient satisfaction with device measured using a Likert scale

Sponsors and collaborators

Lead sponsor

Medical College of Wisconsin

Other

Collaborators

  • Marquette University

Registry information

Official study title

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

Acronym: iPad

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
May 23, 2017
Registry last updated
May 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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