Comparison of Traditional Dysphagia Therapy and Developed Protocol for Dysphagia Patients in Intensive Care Unit
NCT ID: NCT07005427
Last Updated: 2025-08-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
90 participants
INTERVENTIONAL
2025-07-02
2026-05-10
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Comparison group
This Group will receive traditional dysphagia therapy.
dysphagia therapy
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
Experimental Group
This group will receive treatment as per recently designed dysphagia management protocol, that includes the role of early mobilization, dietary intervention with varying postures, and overall care designed for first 48 hours.
Designed protocol for dysphagia
* 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
Interventions
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dysphagia therapy
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
Designed protocol for dysphagia
* 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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* GCS more then 8
Exclusion Criteria
18 Years
ALL
Yes
Sponsors
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Riphah International University
OTHER
Responsible Party
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Principal Investigators
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Anum Ashraf, PhD*
Role: PRINCIPAL_INVESTIGATOR
Riphah International University
Nazia Mumtaz, PhD*
Role: STUDY_DIRECTOR
Riphah International University
Locations
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Riphah International University Lahore Campus
Lahore, Punjab Province, Pakistan
Countries
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Other Identifiers
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Anum Ashraf REC/RCR & AHS/22
Identifier Type: -
Identifier Source: org_study_id
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