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CompletedNCT07005427Updated Sep 29, 2026

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

An interventional study of dysphagia therapy and Designed protocol for dysphagia in Dysphagia, sponsored by Riphah International University. Completed at 1 site in Pakistan. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-29.

Sponsored by Riphah International University · Not applicable, Interventional, and Treatment

Updated Sep 29, 2026Now CompletedEnrollment updatedGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

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.
02

Conditions studied

  • Dysphagia

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Keywords

  • Dysphagia
  • ICU
  • Management Protocol
03

In context

Deglutition Disorders

710 studies on the registry are indexed under Deglutition Disorders; 219 are open to participants now.

This study's enrollment of 90 is above the median of 60 across 471 interventional studies indexed under Deglutition Disorders.

Browse Deglutition Disorders studies →

Lead sponsor

Riphah International University is the lead sponsor of 2,133 studies on the registry; 633 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • Preexisting neurological disorders affecting swallowing, head and neck cancer, inability to follow commands, expected ICU stay \<48 hours
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
90 participants (actual)

Study arms

  • Active comparator
    Comparison group

    This Group will receive traditional dysphagia therapy.

    Other: dysphagia therapy

  • Experimental
    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.

    Behavioral: Designed protocol for dysphagia

Interventions

  • Otherdysphagia 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

    Also known as: traditional dysphagia therapy

  • BehavioralDesigned 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

    Also known as: Guidelines

06

What researchers measure

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)

    Time frame: 6 months

Secondary outcomes

  1. Improved Quality of Life

    • Patient satisfaction with swallowing function

    Time frame: 4 months

07

Study locations

1 site
  • Riphah International University Lahore Campus
    Lahore, Punjab Province 54920, Pakistan
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Status
Active, not recruiting→Completed
changed Sep 29, 2026
Show all 1 update
  1. Sep 29, 2026
    Active, not recruiting→Completed
    + 3 other changes: identifiers, verification date and date precision

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07005427
Lead sponsor
Riphah International University
Responsible party
Sponsor
First posted
Jun 5, 2025
Start date
Jul 2, 2025
Primary completion
Apr 16, 2026
Completion
May 10, 2026
Last update
Sep 29, 2026

Study contacts

Anum Ashraf, PhD*
principal investigator · Riphah International University
Nazia Mumtaz, PhD*
study director · Riphah International University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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