Nursing Care Bundle on Oral Intake Among Critically Ill Children With Post-Extubation Dysphagia

NCT06814457 | Recruiting

• 1 other identifier: KafrelsheikhU5
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

the aim of this study is to evaluate the effect of Nursing care Bundle on Oral Intake among Critically Ill Children with Post-Extubation Dysphagia

Conditions

Oropharyngeal Dysphagia

Outcome Measures

Primary Outcomes (3)

• Change from baseline of oral health post-extubation on Post-Extubation Oral Assessment Scale

  It consisted of eight categories including Voice, ability to swallow, lips, saliva, tongue, mucous membranes, gingiva and teeth. scoring of each component 0 score indicates (normal) , 1 score indicates (mild abnormality) and 2 scores indicate (sever abnormality). Total score (0-3) indicates minimal risk of post-extubation complications ,4-6 indicates moderate risk of complications and 7-10 indicates high risk of post-extubation complications.

  The first measurement time will be From extubation of mechanical ventilation up to 1 week"7 th day's post-extubation". The second time will be from extubation up to 2 week"14th day's" post-extubation

• change from the baseline in swallowing on Pediatric Dysphagia Screening Questionnaire (PDSQ)

  it designed to identify children at risk for oropharyngeal dysphagia. scoring of each component 0 score indicates (no difficultly) ,1 score indicates (mild difficulty)2 scores (moderate difficulty) and 3 score indicates (severe difficulty). Total score (0-5) indicates minimal or to no dysphagia risk ,6-10 indicates to some dysphagia risk, 11-15 indicates high dysphagia risk and 16-18 indicates Severe dysphagia risk.

  The first measurement time will be From extubation of mechanical ventilation up to 1 week"7 th day's post-extubation". The second time will be from extubation up to 2 week"14th day's" post-extubation

• change from baseline of normal oral intake of the children on the Pediatric Functional Oral Intake Scale (P-FOIS)

  it includes a 6-point scale used to assess a child's oral intake ability. It categorizes intake into seven levels, ranging from complete dependence on non-oral feeding to successful oral intake.

  The first measurement time will be From extubation of mechanical ventilation up to 1 week"7 th day's post-extubation". The second time will be from extubation up to 2 week"14th day's" post-extubation

Study Arms (2)

Conventional care group

NO INTERVENTION

Consisted of 30 children who will receive conventional hospital care with no additional interventions.

Care bundle group

EXPERIMENTAL

Consisted of 30 children who will receive a nursing care bundle for enhancing oral intake

Procedure: a nursing care bundle on oral intake

Interventions

a nursing care bundle on oral intake PROCEDURE

a nursing care bundle on oral intake will be started the day after their successful extubation and extend for 14th days. Additionally, the participants will be provided with a brief education on safe swallowing.

Care bundle group

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• undergoing emergency oral endotracheal intubation for at least 48 hours
• able to communicate and having no sensory deficit and accepted to participate in the research

You may not qualify if:

• children who had a history of neuromuscular disease, preexisting swallowing problems and agitated children were excluded.

Sponsors & Collaborators

• Kafrelsheikh University: lead

Study Sites (1)

Kafrelsheikh University

Kafr ash Shaykh, Kafr Ash Shaykh, Kafr el-Sheikh, Egypt,, 33516, Egypt

RECRUITING

MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor of pediatric nursing

Study Record Dates

• First Submitted: February 3, 2025
• First Posted: February 7, 2025
• Study Start: October 1, 2024
• Primary Completion: February 28, 2025
• Study Completion: March 30, 2025
• Last Updated: February 10, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)