Pediatric Post Extubation DysphagiaNCT05828537
The Use of PEDI_ EAT 10 Score Versus Nurse Performed Screening in the Assessment of Post Extubation Dysphagia
An observational study of Pediatric Post Extubation Dysphagia, run by Assiut University.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 year to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatric Post Extubation Dysphagia
- What is being tested?
- endotracheal tube
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 30 Sep 2023to 31 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: pediatric patients admitted to PICU and needed MV
Who may be able to join
- All pediatric patients admitted to PICU and needed mechanical ventilation
Who cannot join
- patient admitted to PICU but not neeed MV
Trial locations and contacts
No sites are listed yet.
Osama M Elasheer, prof contact
About this study
Official title: the Use of PEDI_EAT 10 Score Versus Nurse Performed Screening in the Assessment of Post Extubation Dysphagia
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 .
Read the 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...
- Conditions
- Pediatric Post Extubation Dysphagia
- Being tested
- endotracheal tube
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endotracheal tubeDevice
pediatric extubation
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2023
- Study start30 Sep 2023 (estimated)
- Primary completion30 Sep 2024 (estimated)
- Study completion31 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Post Extubation DysphagiaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Gaber Hassaan Mohamed, Assiut University
- Investigators
- Azhar A Mohamed, lecturer, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05828537
- Sponsor's protocol ID
- pedi postextubation dysphagia
- Status last verified
- Jun 2023
- First submitted
- 12 Apr 2023
- Last updated
- 18 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Use of PEDI_EAT 10 Score Versus Nurse Performed Screening in the Assessment of Post Extubation Dysphagia
- ClinicalTrials.gov ID
- NCT05828537
- Acronym / sponsor ID
- pedi postextubation dysphagia
- Conditions
- Pediatric Post Extubation Dysphagia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 30 Sep 2023 (estimated)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 31 Oct 2024 (estimated)
- First posted
- 25 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 year to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- pediatric patients admitted to PICU and needed MV
Key inclusion criteria (1 listed)
- All pediatric patients admitted to PICU and needed mechanical ventilation
Key exclusion criteria (1 listed)
- patient admitted to PICU but not neeed MV
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| endotracheal tubepediatric extubation | Device | – |
Primary outcome
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 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2023.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Osama M Elasheer, prof contact
Azhar A Mohamed, lecturer study director
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatric Post Extubation Dysphagia, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed G Hassaan, resident (01125813011, sabr14605@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2023.