- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05828537
The Use of PEDI_ EAT 10 Score Versus Nurse Performed Screening in the Assessment of Post Extubation Dysphagia
the Use of PEDI_EAT 10 Score Versus Nurse Performed Screening in the Assessment of Post Extubation Dysphagia
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Invasive mechanical ventilation is one of the most common interventions in critically ill patients, and is invariably characteristic, if not defining, of ICU therapeutic regimen Much attention has been paid to complications occurring during and because of mechanical ventilation, such as nosocomial infections, delirium, and critical illness neuropathy and myopathy. However, an often underappreciated and minimally explored complication of mechanical ventilation is post-extubation dysphagia .
Post-extubation dysphagia (PED) is defined as the difficulty or inability to effectively and safely transfer food and liquid from the mouth to the stomach after extubation.
As reported by Malandraki et al PED is more common in pediatric patients with an overall incidence of 29% and exceeds the 23% incidence reported in adults, Another Australian context showed that 41% of critically-ill pediatric patients requiring endotracheal intubation eventually evolved PED with one-third of those patients experiencing silent aspiration.
Using a prior pioneering prospective study of mechanically ventilated patients, Zuercher et al evaluated 933 extubated patients, of which 116 were screened for the presence of post-extubation dysphagia. They analyzed pre-intubation characteristics to derive factors possibly associated with development of PED, and found that pre-existing neurological disease, emergency admission, increased duration of mechanical ventilation, increased duration of renal replacement therapy, and higher severity of illness were associated with development of post- extubation dysphagia. Interestingly, increased BMI was associated with lower incidence of dysphagia.
Because of the significant negative impact of post-extubation dysphagia on outcomes of pediatric patients, early identification and intervention are crucial. The scientific description of the phenomenon of post-extubation dysphagia in pediatric populations as a distinct pathological entity from the phenomenon in adult populations is considered a corner stone in the systematic exploration of the phenomenon . Such systematic exploration has, to date, been limited...
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Mohamed G Hassaan, resident
- Phone Number: 01125813011
- Email: sabr14605@gmail.com
Study Contact Backup
- Name: Osama M Elasheer, prof
- Phone Number: 01001348864
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- All pediatric patients admitted to PICU and needed mechanical ventilation
Exclusion Criteria:
- patient admitted to PICU but not neeed MV
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assessing the efficiency of PED EAT 10 tool versus nurse performed screening to reliably evaluate PED among all ICU patients needed mechanical ventilation by detecting outcome: -oral feeding at ICU discharge
Time Frame: 1 year
|
Assessing the efficiency of PED EAT 10 tool versus nurse performed screening to reliably evaluate PED among all ICU patients needed mechanical ventilation by detecting outcome: -oral feeding at ICU discharge |
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assessing the efficiency of PED EAT 10 tool versus nurse performed screening to reliably evaluate PED among all ICU patients needed mechanical ventilation by detecting outcome: ICU readmission.
Time Frame: 1 year
|
Assessing the efficiency of PED EAT 10 tool versus nurse performed screening to reliably evaluate PED among all ICU patients needed mechanical ventilation by detecting outcome: ICU readmission. |
1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Azhar A Mohamed, lecturer, Assiut University
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- pedi postextubation dysphagia
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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