Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Communication
  • Ventilation Therapy; Complications
Type
Interventional
Phase
Not Applicable
Design
Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Other

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

Intensive Care Unit (ICU) admissions constitute a major part of hospital activity and resource allocation, and the number of patient days in ICUs and on mechanical ventilation is increasing. More than 5 million patients are admitted to an ICU annually in the United States, and approximately 55,000 c...

Intensive Care Unit (ICU) admissions constitute a major part of hospital activity and resource allocation, and the number of patient days in ICUs and on mechanical ventilation is increasing. More than 5 million patients are admitted to an ICU annually in the United States, and approximately 55,000 critically ill patients are cared for each day. The most common cause for admission is respiratory insufficiency or failure; a study of data from 2005-2007 estimated that nearly 40 percent of ICU patients require mechanical ventilation. Patients experience frequent emotional and psychiatric complications from ICU stays, including depression, anxiety, and post-traumatic stress disorder. One 2011 study found a prevalence of "clinically significant" depressive symptoms ranging from 17 percent to 43 percent among post-ICU patients. In 2013, it was reported that up to 50 percent of patients experience general anxiety symptoms one year after discharge, a rate much higher than in the broader US population. Patients who temporarily lose the ability to speak report a high level of frustration. A study of 127 patients reported that, "two stressors, being intubated and not being able to talk, were significantly more stressful… than all the other stressors. The mean stressfulness score for [25] other stressors was between no distress and mild distress." Improving subject communication with ICU care team will likely require better technological interventions, and current best practice for assessing the optimal patient communication method is dependent on the evaluation of an experienced speech-language pathologist (SLP). Current approaches are insufficient for patient's needs, as one representative study described: "Patients rated 40% of the communication sessions with nurses as somewhat difficult to extremely difficult. Assistive communication strategies were uncommon, with little to no use of assistive communication materials (e.g., writing supplies, alphabet or word boards)." Designing an effective mode of communication for ICU patients unable to speak due to mechanical ventilation will likely improve patient's experiences and, potentially, long-term outcomes. Some limited technologies exist to address these issues; however, they are not in widespread use due to a variety of reasons, including cost, lack of intuitiveness, and design that is not appropriate for the ICU setting. The investigators are designing a technological solution to assist ICU subjects in communicating with their caregivers, particularly nurses. The investigators are planning to do the initial testing of this device in the adult ICUs at the University of Massachusetts/UMass Memorial Medical Center at both the University Campus and Memorial Campus. The purpose of this stage of the project is to test the current device and determine whether the physical factors and interaction modes that have been designed up to this point will be appropriate for the needs and desires of ICU subjects while communicating.

Tracking Information

NCT #
NCT04105751
Collaborators
Brown University
Investigators
Principal Investigator: J. Matthias Walz, MD UMass Medical School