Swallowing Impairments in ICU Survivors and Community-Dwelling Adults

Vanderbilt University Medical Center

Status: Not yet enrolling

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

Study type: Observational

Funder types: Other

Identifiers

NCT07005037

250839

Details and patient eligibility

About

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.

Full 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.

Enrollment: 460 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

460 participants in 2 patient groups

Healthy community dwelling adults

Description:

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

ICU survivors and their care partners

Description:

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