Clinical trial NCT07005427: Comparison of Traditional Dysphagia Therapy and Developed Protocol for Dysphagia Patients in Intensive Care Unit
Official title: Development of Dysphagia Management Protocol for Adult Patients in Intensive Care Unit
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Dysphagia
Keywords: Dysphagia
ICU
Management Protocol
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2025-06-05
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Improved Swallow Capacity
timeFrame: 6 months
Secondary outcomes:
measure: Improved Quality of Life
timeFrame: 4 months
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Riphah International University Lahore Campus
state: Punjab
Study officials:
affiliation: Riphah International University
name: Anum Ashraf, PhD*
role: PRINCIPAL_INVESTIGATOR
affiliation: Riphah International University
name: Nazia Mumtaz, PhD*
role: STUDY_DIRECTOR
References: