Swallowing Impairments in ICU Survivors and Community-Dwelling Adults (NCT07005037) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Swallowing Impairments in ICU Survivors and Community-Dwelling Adults
United States460 participantsStarted 2027-04-01
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. \<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
What they're measuring
1
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.
✕. 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).