NCT05828537

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 .

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2023

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 12, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 25, 2023

Completed
5 months until next milestone

Study Start

First participant enrolled

September 30, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2024

Completed
Last Updated

June 18, 2023

Status Verified

June 1, 2023

Enrollment Period

1 year

First QC Date

April 12, 2023

Last Update Submit

June 16, 2023

Conditions

Pediatric Post Extubation Dysphagia

Outcome Measures

Primary Outcomes (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

    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 Outcomes (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

Interventions

endotracheal tubeDEVICE

pediatric extubation

Eligibility Criteria

Age1 Year - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

pediatric patients admitted to PICU and needed MV

You may qualify if:

  • All pediatric patients admitted to PICU and needed mechanical ventilation

You may not qualify if:

  • patient admitted to PICU but not neeed MV

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Azhar A Mohamed, lecturer

    Assiut University

    STUDY DIRECTOR

Central Study Contacts

Mohamed G Hassaan, resident

CONTACT

01125813011sabr14605@gmail.com

Osama M Elasheer, prof

CONTACT

01001348864

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
resident

Study Record Dates

First Submitted

April 12, 2023

First Posted

April 25, 2023

Study Start

September 30, 2023

Primary Completion

September 30, 2024

Study Completion

October 31, 2024

Last Updated

June 18, 2023

Record last verified: 2023-06