Post-Critical Illness Dysphagia in the Intensive Care Unit (the Dysphagia-ICU Study): Protocol for a Prospective Cohort Study.

Background: Post-critical illness dysphagia occurs in about 10% to 62% of patients in the intensive care unit (ICU). Studies focusing on risk factors for dysphagia following endotracheal intubation are scarce and provide conflicting results. More research is required to determine the true prevalence of dysphagia, possible mechanisms, and risk factors.

Objective: The aims of the study are to determine (1) risk factors associated with post-critical illness dysphagia, (2) the prevalence of post-critical illness dysphagia, (3) outcomes of patients with post-critical illness dysphagia, and (4) the diagnostic accuracy of the water sip test compared to fiber-optic endoscopic evaluation of swallowing (FEES).

Methods: We plan to undertake a single-center prospective cohort study of patients with post-critical illness dysphagia admitted to the ICU at Prince Sultan Military Medical City, Saudi Arabia. Our inclusion criteria are as follows: (1) being an adult (age 18 years and older), (2) having undergone invasive mechanical ventilation for >24 hours, (3) having been extubated for >24 hours, (4) being able to participate in a FEES, and (5) being hemodynamically stable. Each day, the research coordinator will screen all patients in the ICU for enrollment in the study. The research coordinator will collect daily data on the use of advanced life support, the need for mechanical ventilation, and outcomes (mortality, duration of mechanical ventilation, ICU length of stay, and hospital length of stay). Enrolled patients will undergo a water sip test in the ICU and FEES performed by a certified speech-language pathologist. Patients will then be followed during a hospital stay truncated for analysis at 30 days as two cohorts: (1) patients that have dysphagia, that is, abnormal FEES results; and (2) patients who have normal FEES results. Logistic regression will identify dysphagia risk factors (eg, age, Acute Physiology and Chronic Health Evaluation II score, and ventilation duration), while sensitivity and specificity tests will be used to compare the results of the water sip test to the FEES. Survival analysis will be used to evaluate 30-day outcomes.

Results: The study anticipates enrolling 200 patients over 18 months. Key outcomes include dysphagia prevalence and risk factors. Final results will be analyzed and reported upon completion of the 30-day follow-up for all participants. As of July 13, 2025, a total of 45 patients had been enrolled, with an average recruitment rate of 7.5 patients per month.

Conclusions: The study findings will promote early intervention for patients with post-critical illness dysphagia, improve multidisciplinary care, and inform policymakers for better resource allocation. This study lays the groundwork for future research and clinical guidelines tailored to Saudi Arabia's health care context.

International Registered Report Identifier (irrid): PRR1-10.2196/68053.