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

NCT07005427 | Active Not Recruiting

• 1 other identifier: Anum Ashraf REC/RCR & AHS/22
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dysphagia

Keywords

Dysphagia; ICU; Management Protocol

Outcome Measures

Primary Outcomes (1)

• 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)

  6 months

Secondary Outcomes (1)

• Improved Quality of Life

  4 months

Study Arms (2)

Comparison group

ACTIVE COMPARATOR

This Group will receive traditional dysphagia therapy.

Other: dysphagia therapy

Experimental Group

EXPERIMENTAL

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.

Behavioral: Designed protocol for dysphagia

Interventions

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

Also known as: traditional dysphagia therapy

Comparison group

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

Also known as: Guidelines

Experimental Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Riphah International University Lahore Campus

Lahore, Punjab Province, 54920, Pakistan

Location

MeSH Terms

Conditions

Deglutition Disorders

Interventions

Guidelines as Topic

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Anum Ashraf, PhD*

  Riphah International University

  PRINCIPAL INVESTIGATOR

• Nazia Mumtaz, PhD*

  Riphah International University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2025
• First Posted: June 5, 2025
• Study Start: July 2, 2025
• Primary Completion: April 16, 2026
• Study Completion: May 10, 2026
• Last Updated: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)