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

February 6, 2025 updated by: Eman Wardany Abdelaal Mohamed, Kafrelsheikh University

The Effect of Nursing Care Bundle on Oral Intake Among Critically Ill Children With Post-Extubation Dysphagia: Randomized Control Study

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The researchers explained the study's aim, benefits, and procedures for participation, after that the parents of the children provided an informed consent. children's baseline data was collected from their records prior to intervention in order to identify children who meet the required criteria of the study. then the participants were selected and divided randomly (using a simple random method) into two equal groups. One subject for the control group, one for the study group, and so on, distributed the participants into two equivalent groups as fellow:

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

Study Group: Consisted of 30 children who will receive a nursing care bundle on oral intake starting the day after their successful extubation and extend for 14th days. Additionally, the participants were provided with a brief education on safe swallowing.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Conventional care group
Consisted of 30 children who will receive conventional hospital care with no additional interventions.
Experimental: Care bundle group
Consisted of 30 children who will receive a nursing care bundle for enhancing oral intake
Procedure: a nursing care bundle on oral intake
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline of oral health post-extubation on Post-Extubation Oral Assessment Scale
Time Frame: 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
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)
Time Frame: 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
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)
Time Frame: 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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kafrelsheikh University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2024

Primary Completion (Estimated)

February 28, 2025

Study Completion (Estimated)

March 30, 2025

Study Registration Dates

First Submitted

February 3, 2025

First Submitted That Met QC Criteria

February 3, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 6, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KafrelsheikhU5

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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