CTSI-iPad for Vented Patient Communication

Respiratory Failure Clinical Trial

— iPad  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03163823
• Other study ID #: 27533
• Secondary ID: 9665310
• Status: Completed
• Phase: N/A
• Start date: February 23, 2017
• Est. completion date: September 21, 2020

Study information

• Verified date: May 2021
• Source: Medical College of Wisconsin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: September 21, 2020
• Est. primary completion date: September 21, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Respiratory Failure
• Respiratory Insufficiency

Intervention

Other:
• Proloquo2Go
Use of communication application Proloquo2Go modified for the ICU setting on an iPad device
• Standard of Care
Standard of Care communication methods

Locations

Country	Name	City	State
United States	Froedtert Memorial Lutheran Hospital	Milwaukee	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
Medical College of Wisconsin	Marquette University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ease of Communication	Patient self-reported ease of communication during mechanical ventilation measured using a Likert scale	30 Days
Secondary	Patient Anxiety	Patient Anxiety while Mechanically Ventilated in an ICU measured by VAS anxiety	30 Days
Secondary	Patient Satisfaction	Mechanically ventilated ICU patient satisfaction with device measured using a Likert scale	30 Days