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NCT Number: NCT06814457

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

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

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Key information

Conditions

Oropharyngeal Dysphagia Deglutition Disorders Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Otorhinolaryngologic Diseases Pharyngeal Diseases

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kafrelsheikh University

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

Location status: Recruiting

Location contact

Eman W abdelaal, Ass. Professor

CONTACT

[email protected]

01065407334

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Kafrelsheikh University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 7, 2025
Registry last updated
Feb 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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