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Search / Trial NCT07005037

Swallowing Impairments in ICU Survivors and Community-Dwelling Adults

Launched by VANDERBILT UNIVERSITY MEDICAL CENTER · May 26, 2025

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

ClinConnect Summary

This clinical trial is designed to study swallowing difficulties, known as dysphagia, in adults who have recently recovered from being in the intensive care unit (ICU). Many older adults who survive an ICU stay face ongoing challenges, including physical and mental health issues, which are part of a condition called post-intensive care syndrome (PICS). The research aims to understand how common dysphagia is among these individuals, what factors might lead to swallowing problems, how patients recover their swallowing abilities over time, and how these difficulties affect their overall health and quality of life, as well as the burden on their caregivers.

To participate in this study, adult patients aged 18 and older who have been critically ill in the ICU may be eligible, provided they do not have a history of neurological or respiratory diseases, head and neck surgery, or previous swallowing problems. Caregivers of these patients can also take part if they are willing to complete a questionnaire. Participants can expect to contribute to important findings that could improve care for ICU survivors and their families. It’s also important to note that the trial is still in the planning stages and has not yet started recruiting participants.

Gender

ALL

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.

About Vanderbilt University Medical Center

Vanderbilt University Medical Center (VUMC) is a leading academic medical center located in Nashville, Tennessee, renowned for its commitment to advancing healthcare through innovative research and clinical excellence. As a prominent sponsor of clinical trials, VUMC integrates cutting-edge scientific inquiry with patient-centered care, supporting a diverse array of studies aimed at enhancing medical knowledge and improving treatment outcomes. With a robust infrastructure and a multidisciplinary team of experts, VUMC fosters collaboration across various fields, ensuring the highest standards of safety and ethical considerations in its research endeavors. Through its dedication to medical discovery and education, VUMC plays a pivotal role in shaping the future of medicine.

Locations

Nashville, Tennessee, United States

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported