Swallowing Impairments in ICU Survivors and Community-Dwelling Adults (NCT07005037) | Clinical Trial Compass
WithdrawnNot Applicable
Swallowing Impairments in ICU Survivors and Community-Dwelling Adults
Stopped: Change of scope of the work given feedback from funding agency leading to new IRB/clinicaltrials.gov registration.
United States0Started 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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1I read about a withdrawn study on swallowing problems in ICU survivors — since it's no longer recruiting, can you tell me if there are any currently active studies on post-ICU swallowing difficulties that might be appropriate to discuss for my situation?
2My loved one is recovering from an ICU stay and seems to have trouble swallowing safely — is this something called post-intensive care syndrome, and how does it usually get evaluated and treated outside of a research study?
3Since this particular trial was withdrawn before enrolling anyone, does that mean there's limited research evidence on swallowing impairments after ICU care, and how does that affect the treatment options you'd recommend?
4The study was also looking at caregiver burden alongside the patient's swallowing issues — is that something our care team can help us address through existing support services right now?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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.
. 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).