DysphagiaNCT07005427
Comparison of Traditional Dysphagia Therapy and Developed Protocol for Dysphagia Patients in Intensive Care Unit
A study testing dysphagia therapy and Designed protocol for dysphagia in people with Dysphagia, run by Riphah International University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dysphagia
- What is being tested?
- dysphagia therapy and Designed protocol for dysphagia
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 sitePakistan
- Study dates
- 2 Jul 2025to 10 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult patients (≥18 years) admitted to ICU with confirmed dysphagia by bedside evaluation within 72 hours of admission
- GCS more then 8
Who cannot join
- Preexisting neurological disorders affecting swallowing, head and neck cancer, inability to follow commands, expected ICU stay <48 hours
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Riphah International University Lahore Campus
Lahore, Punjab Province, 54920
About this study
Official title: Development of Dysphagia Management Protocol for Adult 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.
Read the detailed description
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.
- Conditions
- Dysphagia
- Being tested
- dysphagia therapy, Designed protocol for dysphagia
- Keywords
- Dysphagia, ICU, Management Protocol
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dysphagia therapyOther
Also called traditional 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 dysphagiaBehavioural
Also called Guidelines
- 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
| Study group | Role | What they receive |
|---|---|---|
| Comparison group | Active comparator | This Group will receive traditional dysphagia therapy. Receives: 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. Receives: Behavioral: Designed protocol for dysphagia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 6 months
Secondary outcomes (1)
Improved Quality of Life
- Patient satisfaction with swallowing function
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2025
- Study start2 Jul 2025
- Primary completion16 Apr 2026
- Study completion10 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysphagiaStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anum Ashraf, PhD*, Principal investigator, Riphah International UniversityNazia Mumtaz, PhD*, Study director, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07005427
- Sponsor's protocol ID
- Anum Ashraf 1107
- Status last verified
- Sep 2026
- First submitted
- 15 May 2025
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Dysphagia Management Protocol for Adult Patients in Intensive Care Unit
- ClinicalTrials.gov ID
- NCT07005427
- Acronym / sponsor ID
- Anum Ashraf 1107
- Conditions
- Dysphagia
- Keywords
- Dysphagia, ICU, Management Protocol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 2 Jul 2025 (actual)
- Primary completion
- 16 Apr 2026 (actual)
- Study completion
- 10 May 2026 (actual)
- First posted
- 5 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Comparison group | Active comparator | Other: dysphagia therapyThis Group will receive traditional dysphagia therapy. |
| Experimental Group | Experimental | Behavioral: Designed protocol for dysphagiaThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients (≥18 years) admitted to ICU with confirmed dysphagia by bedside evaluation within 72 hours of admission
- GCS more then 8
Key exclusion criteria (1 listed)
- Preexisting neurological disorders affecting swallowing, head and neck cancer, inability to follow commands, expected ICU stay <48 hours
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dysphagia therapyAlso: traditional dysphagia therapyThis 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 | Comparison group |
| Designed protocol for dysphagiaAlso: Guidelines* 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 | Behavioural | Experimental Group |
Primary outcome
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)
1 secondary outcome
Improved Quality of Life
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anum Ashraf, PhD* principal investigator
Riphah International University
Nazia Mumtaz, PhD* study director
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dysphagia therapy and Designed protocol for dysphagia in people with Dysphagia, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improved Swallow Capacity (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.