Dysphagia (swallowing disorders) in intensive care unit (ICU) patients is associated with poor outcomes, including aspiration pneumonia, prolonged hospitalization, and increased mortality. Traditional dysphagia management approaches may be insufficient for the unique needs of critically ill patients. This study aims to evaluate the effectiveness of a newly developed ICU-specific dysphagia protocol compared to traditional therapy approaches.
The aim of this study are: 1. To compare the efficacy of traditional dysphagia therapy versus a developed ICU-specific protocol in improving swallowing function 2. To assess the impact of both approaches on clinical outcomes including aspiration rates, time to oral intake, ICU length of stay, and pneumonia incidence 3. To identify patient subgroups that may benefit most from the specialized protocol Methods Study Design * Prospective randomized controlled trial * Single-center study in a tertiary hospital ICU * 1:1 randomization to intervention or control group Participants * Total sample size: 90 adult ICU patients (45 per group) * Inclusion criteria: Adult patients (≥18 years) admitted to ICU with confirmed dysphagia by bedside evaluation within 72 hours of admission * Exclusion criteria: Preexisting neurological disorders affecting swallowing, head and neck cancer, inability to follow commands, expected ICU stay \<48 hours This study will provide evidence for the efficacy of a specialized dysphagia management protocol tailored to the unique needs of critically ill patients. If proven effective, the protocol could establish new standards of care for dysphagia management in ICU settings, potentially improving patient outcomes and reducing healthcare costs associated with dysphagia-related complications.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
90
This group will receive usual dysphagia care as provided in ICU settings * Standard bedside swallowing evaluation * Conventional compensatory strategies (postural changes, diet modifications) * Traditional exercises focusing on oral motor control * Therapy sessions 3 times per week for 30 minutes
* Innovative strengthening exercises adapted for ICU setting * Early mobilization component * ICU-specific compensatory strategies * Therapy sessions 5 times per week for 30 minutes with additional brief daily reinforcement
Riphah International University Lahore Campus
Lahore, Punjab Province, Pakistan
Improved Swallow Capacity
• Change in Functional Oral Intake Scale (FOIS) score from baseline to discharge (at discharge it should be more then 5 on its rating scale)
Time frame: 6 months
Improved Quality of Life
• Patient satisfaction with swallowing function
Time frame: 4 months
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