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NCT Number: NCT07005427

Comparison of Traditional Dysphagia Therapy and Developed Protocol for Dysphagia Patients in Intensive Care Unit

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Dysphagia Deglutition Disorders Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Otorhinolaryngologic Diseases Pharyngeal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Riphah International University Lahore Campus

Lahore, Punjab Province, 54920, Pakistan

About this study

The aim of this study are:

  • To compare the efficacy of traditional dysphagia therapy versus a developed ICU-specific protocol in improving swallowing function
  • To assess the impact of both approaches on clinical outcomes including aspiration rates, time to oral intake, ICU length of stay, and pneumonia incidence
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients (≥18 years) admitted to ICU with confirmed dysphagia by bedside evaluation within 72 hours of admission
  • GCS more then 8

Exclusion criteria

  • Preexisting neurological disorders affecting swallowing, head and neck cancer, inability to follow commands, expected ICU stay <48 hours

Treatment and study plan

dysphagia therapy

Other

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

Other names: traditional dysphagia therapy

Designed protocol for dysphagia

Behavioral
  • 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 names: Guidelines

Primary outcomes

  1. Improved Swallow Capacity

    Time frame: 6 months

    • Change in Functional Oral Intake Scale (FOIS) score from baseline to discharge (at discharge it should be more then 5 on its rating scale)

Secondary outcomes

  1. Improved Quality of Life

    Time frame: 4 months

    • Patient satisfaction with swallowing function

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

Development of Dysphagia Management Protocol for Adult Patients in Intensive Care Unit

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 5, 2025
Registry last updated
Aug 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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