Clinical trial NCT06814457: Nursing Care Bundle on Oral Intake Among Critically Ill Children With Post-Extubation Dysphagia
Official title: The Effect of Nursing Care Bundle on Oral Intake Among Critically Ill Children With Post-Extubation Dysphagia: Randomized Control Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Oropharyngeal Dysphagia
Lead sponsor: Kafrelsheikh University
Sponsor class: OTHER
First posted: 2025-02-07
Enrollment: 60
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline of oral health post-extubation on Post-Extubation Oral Assessment Scale
timeFrame: 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
measure: change from the baseline in swallowing on Pediatric Dysphagia Screening Questionnaire (PDSQ)
timeFrame: 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
measure: change from baseline of normal oral intake of the children on the Pediatric Functional Oral Intake Scale (P-FOIS)
timeFrame: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Kafr Ash Shaykh
country: Egypt
facility: Kafrelsheikh University
state: Kafr Ash Shaykh, Kafr el-Sheikh, Egypt,
Study officials:
References: