Swallowing Impairments in ICU Survivors and Community-Dwelling Adults

NCT07005037 | Not Yet Recruiting

• 1 other identifier: 250839
• Study Type: observational
• Target: 460
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Intensive Care Syndrome; Caregiver Burden; Dysphagia; Healthy Aging

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• 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.

• 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.

• 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.

• 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.

• 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.

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• \<18 years old
• neurological disease or respiratory disease diagnosis
• history of head and neck cancer/surgery to the head and neck region
• history of dysphagia.
• adult ≥ 18 years old
• ICU patients requiring monitoring or treatment for respiratory failure and/or shock (e.g., hypovolemic, septic, and/or cardiogenic)
• cognitive capacity and willingness to provide informed consent
• 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).
• neurological disease diagnosis
• history of head and neck cancer/surgery to the head and neck region
• history of dysphagia prior to ICU admission.
• willing to complete questionnaire.
• not a caregiver of critically ill adult
• unwilling to complete questionnaire.

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Deglutition Disorders; postintensive care syndrome; Caregiver Burden

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Stress, Psychological; Behavioral Symptoms; Behavior

Central Study Contacts

Cara Donohue, PhD CCC-SLP

CONTACT

615-852-5085; cara.donohue@vumc.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Director of Medical Speech-Language Pathology

Study Record Dates

• First Submitted: May 26, 2025
• First Posted: June 4, 2025
• Study Start (Estimated): April 1, 2027
• Primary Completion (Estimated): July 30, 2029
• Study Completion (Estimated): July 30, 2030
• Last Updated: March 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)