Swallowing Impairments in ICU Survivors and Community-Dwelling Adults

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

460 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-01-01

Study Completion Date

2030-07-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Dysphagia Healthy Aging Post Intensive Care Syndrome Caregiver Burden

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Healthy community dwelling adults

Healthy community dwelling adults who meet the inclusion criteria for the study will be enrolled.

No interventions assigned to this group

ICU survivors and their care partners

Critically ill adults and their care partners who meet inclusion criteria for the study will be enrolled.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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.

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).

2. willing to complete questionnaire.

Exclusion Criteria

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.

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.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes