Pedi Postextubation Dysphagia

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05828537
Collaborator
(none)
100
13

Study Details

Study Description

Brief Summary

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 .

Condition or Disease Intervention/Treatment Phase
  • Device: endotracheal tube

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 Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
the Use of PEDI_EAT 10 Score Versus Nurse Performed Screening in the Assessment of Post Extubation Dysphagia
Anticipated Study Start Date :
Apr 30, 2023
Anticipated Primary Completion Date :
Apr 30, 2024
Anticipated Study Completion Date :
May 31, 2024

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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]

Eligibility Criteria

Criteria

Ages Eligible for Study:
1 Year to 16 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • All pediatric patients admitted to PICU and needed mechanical ventilation
Exclusion Criteria:
  • patient admitted to PICU but not neeed MV

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

  • Study Director: Azhar A Mohamed, lecturer, Assiut University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mohamed Gaber Hassaan Mohamed, resident, Assiut University
ClinicalTrials.gov Identifier:
NCT05828537
Other Study ID Numbers:
  • pedi postextubation dysphagia
First Posted:
Apr 25, 2023
Last Update Posted:
Apr 25, 2023
Last Verified:
Apr 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 25, 2023