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

Riphah International University

Status: Active, not recruiting

Conditions: Dysphagia

Treatments: Behavioral: Designed protocol for dysphagia; Other: dysphagia therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT07005427

Anum Ashraf REC/RCR & AHS/22

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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90 participants in 2 patient groups

Comparison group

Active Comparator group

Description:

This Group will receive traditional dysphagia therapy.

Treatment:

Other: dysphagia therapy

Experimental Group

Experimental group

Description:

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.

Treatment:

Behavioral: Designed protocol for dysphagia