Swallowing Impairments in ICU Survivors and Community-Dwelling Adults

Improving Recovery in Older ICU Survivors: Evaluation of Swallowing Dysfunction and Aspiration Risk

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.

Study Overview

• Status: Withdrawn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

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 Type: Observational

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

We will enroll 100 community dwelling adults who meet inclusion criteria, 180 critically ill adults who meet inclusion criteria, and 180 caregivers of critically ill adults who meet inclusion criteria.

Description

Inclusion criteria community-dwelling adults:

1. adult ≥18 years old
2. no prior history of neurological diseases or respiratory diseases
3. no prior history of head and neck surgery/head and neck cancer/radiation to head and neck region
4. no prior history of dysphagia.

Exclusion criteria community-dwelling adults:

1. <18 years old
2. neurological disease or respiratory disease diagnosis
3. history of head and neck cancer/surgery to the head and neck region
4. history of dysphagia.

Inclusion criteria critically-ill adults:

1. adult ≥ 18 years old
2. ICU patients requiring monitoring or treatment for respiratory failure and/or shock (e.g., hypovolemic, septic, and/or cardiogenic)
3. cognitive capacity and willingness to provide informed consent
4. medically stable for testing (e.g., can sit upright, respiratory status is stable [Sp02 > 90%, off mechanical ventilation or CPAP/BiPAP for > 30 minutes, respiratory rate < 30 bpm], and Richmond Agitation-Sedation Scale score is 0 (awake and alert).

Exclusion criteria critically ill adults:

1. neurological disease diagnosis
2. history of head and neck cancer/surgery to the head and neck region
3. history of dysphagia prior to ICU admission.

Inclusion criteria caregivers:

1. caregiver of critically ill adult who meets inclusion criteria for study
2. willing to complete questionnaire.

Exclusion criteria caregivers:

1. not a caregiver of critically ill adult
2. unwilling to complete questionnaire.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Healthy community dwelling adults; Healthy community dwelling adults who meet the inclusion criteria for the study will be enrolled.
ICU survivors and their care partners; Critically ill adults and their care partners who meet inclusion criteria for the study will be enrolled.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Swallowing safety and efficiency	The validated Dynamic Imaging Grade of Swallowing Toxicity (DIGEST) scale will be used to measure 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.

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Vanderbilt University Medical Center

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2027
• Primary Completion (Estimated): July 30, 2029
• Study Completion (Estimated): July 30, 2030

Study Registration Dates

• First Submitted: May 26, 2025
• First Submitted That Met QC Criteria: May 26, 2025
• First Posted (Actual): June 4, 2025

Study Record Updates

• Last Update Posted (Actual): June 2, 2026
• Last Update Submitted That Met QC Criteria: May 29, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Digestive System Diseases; Gastrointestinal Diseases; Esophageal Diseases; Otorhinolaryngologic Diseases; Pharyngeal Diseases; Stress, Psychological; Behavior; Caregiver Burden; Deglutition Disorders; postintensive care syndrome
• Other Study ID Numbers: 250839

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No