Swallowing Impairments in ICU Survivors and Community-Dwelling Adults

Not yet recruiting

• Conditions: Dysphagia; Healthy Aging; Post Intensive Care Syndrome; Caregiver Burden

• Registration Number: NCT07005037
• Lead Sponsor: Vanderbilt University Medical Center

Brief Summary

Post-intensive care syndrome (PICS), which consists of physical, cognitive, and psychosocial problems, is a pervasive complication for older intensive care unit (ICU) survivors and contributes to detrimental health outcomes and significant reductions in quality of life. Yet, little is known about the relationship between PICS, swallowing difficulties (dysphagia), and other ICU-related negative outcomes such as frailty and Alzheimer's Disease and Related Dementias (ADRD). The primary purpose of this research study is to determine the prevalence and severity of dysphagia, risk factors for dysphagia development, recovery patterns of dysphagia over time, and the impact of dysphagia on health outcomes, quality of life, and care partner burden in adult ICU survivors with PICS.

Detailed Description

This study will involve one in-person research visit for community dwelling adults and two research visits for critically ill adults (one in the ICU, one 3-months post-hospital discharge) that will last approximately 1 hour and will consist of a screening, cough testing, swallow function testing, assessments of hand grip and tongue strength, and completion of questionnaires. Caregivers of ICU survivors will complete questionnaires at the 3-month follow up visit.

Study Timeline

• Study First Submitted: 2025-05-26
• Study First Submitted QC: 2025-05-26
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-03
• Study First Posted: 2025-06-04
• Last Update Posted: 2025-06-05
• Study Start: 2025-08-01
• Primary Completion: 2029-07-30
• Study Completion: 2030-07-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 460

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Swallowing safety and efficiency	During baseline visit at time of enrollment for community dwelling adults. During baseline visit at time of enrollment and 3 months post-hospital discharge for critically ill adults.	The validated Dynamic Imaging Grade of Swallowing Toxicity (DIGEST) scale will be used to measure swallowing safety and efficiency.

Secondary Outcome Measures

Name	Time	Method
Voluntary cough peak expiratory flow	During baseline visit at time of enrollment for community dwelling adults. During baseline visit at time of enrollment and 3 months post-hospital discharge for critically ill adults.	A measure of cough strength
Grip strength	During baseline visit at time of enrollment for community dwelling adults. During baseline visit at time of enrollment and 3 months post-hospital discharge for critically ill adults.	Grip strength be used to quantify clinical frailty using a digital hand dynamometer.
Tongue strength	During baseline visit at time of enrollment for community dwelling adults. During baseline visit at time of enrollment and 3 months post-hospital discharge for critically ill adults.	Tongue strength will be assessed using the Iowa Oral Pressure Instrument (IOPI).
Swallowing and Eating Related Fatigue Questionnaire (SERF)	During baseline visit at time of enrollment for community dwelling adults. During baseline visit at time of enrollment and 3 months post-hospital discharge for critically ill adults.	Scores on the SERF range 0-48 with higher scores indicating greater impairment.
Eating Assessment Tool 10 (EAT-10)	During baseline visit at time of enrollment for community dwelling adults. During baseline visit at time of enrollment and 3 months post-hospital discharge for critically ill adults.	The EAT-10 contains 10 questions (score range: 0-40), higher scores indicate greater impairment.
3 oz water swallow test	During baseline visit at time of enrollment for community dwelling adults. During baseline visit at time of enrollment and 3 months post-hospital discharge for critically ill adults.	Participants will be given a cup of three ounces of water and instructed to drink the water continuously. Fail criteria includes interrupted drinking and/or coughing/throat clearing during or immediately following the drinking task.
Reflex cough	During baseline visit at time of enrollment for community dwelling adults. During baseline visit at time of enrollment and 3 months post-hospital discharge for critically ill adults.	Participants will undergo reflex cough testing.
Screening for Oral Frailty Tool (SOFT)	During baseline visit at time of enrollment for community dwelling adults. During baseline visit at time of enrollment and 3 months post-hospital discharge for critically ill adults.	Oral frailty will be assessed as present/absent using the Screening for Oral Frailty Tool.
Swallowing Related Quality of Life Questionnaire (SWAL-QOL)	During baseline visit at time of enrollment for community dwelling adults. 3 months post-hospital discharge for critically ill adults.	Scores on the SWAL-QOL range from 0-100 with lower scores indicating greater impairment.
Caregiver Analysis of Reported Experiences with Swallowing Disorders (CARES) Questionnaire	3 months post-hospital discharge for care partners of critically ill adults.	Scores on the CARES range from 0-26 with higher scores indicating greater caregiver burden.

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States