Clinical trial NCT07005037: Swallowing Impairments in ICU Survivors and Community-Dwelling Adults
Official title: Improving Recovery in Older ICU Survivors: Evaluation of Swallowing Dysfunction and Aspiration Risk
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Dysphagia
Healthy Aging
Post Intensive Care Syndrome
Caregiver Burden
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2025-06-04
Enrollment: 460
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Swallowing safety and efficiency
timeFrame: 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:
measure: Voluntary cough peak expiratory flow
timeFrame: 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.
measure: Grip strength
timeFrame: 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.
measure: Tongue strength
timeFrame: 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.
measure: Swallowing and Eating Related Fatigue Questionnaire (SERF)
timeFrame: 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.
measure: Eating Assessment Tool 10 (EAT-10)
timeFrame: 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.
measure: 3 oz water swallow test
timeFrame: 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.
measure: Reflex cough
timeFrame: 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.
measure: Screening for Oral Frailty Tool (SOFT)
timeFrame: 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.
measure: Swallowing Related Quality of Life Questionnaire (SWAL-QOL)
timeFrame: During baseline visit at time of enrollment for community dwelling adults. 3 months post-hospital discharge for critically ill adults.
measure: Caregiver Analysis of Reported Experiences with Swallowing Disorders (CARES) Questionnaire
timeFrame: 3 months post-hospital discharge for care partners of critically ill adults.
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
References: