DysphagiaEarly Phase 1CPNCT07081399
the Effect of Adult Intubated Patient Clinical Pathway on Post-extubation Complications Prevention
A Early Phase 1 study testing ETT cuff pressure monitoring, ETT suctioning, cough augmentation technique, swallowing exercises,: Nebulized budesonide 1mg and IV methylprednisolone 40 mg we in people with Dysphagia and Dysphagia Rehabilitation, run by Damanhour University at 1 site in Egypt.
Trial summary
Post- extubation complications delay the complete recovery of critically ill patient. The clinical pathway is one strategies that help to manage and control these complications. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Dysphagia, Dysphagia Rehabilitation
- What is being tested?
- ETT cuff pressure monitoring, ETT suctioning, cough augmentation technique, swallowing exercises,: Nebulized budesonide 1mg and IV methylprednisolone 40 mg we
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 8 Aug 2024to Aug 2025
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adult (>18 years)
- orally intubated patients for the first time attached with MV for less than two weeks
- with Glasgow coma scale (GCS) from 13-15.
Who cannot join
- patients admitted with high risk for laryngeal edema,
- difficult intubation,
- ETT/anterior-posterior diameter ˃45%,
- self-extubation, and
- planned for tracheostomy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
heba attia effect of adult intubated CP on post-extubation complications contact
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Nursing, Damanhour University
Damanhūr, Egypt
effect of adult intubated CP on post-extubation complications, 045 3311679, admin.nur@nur.dmu.edu.eg
effect of adult intubated CP on post-extubation complications
About this study
Post- extubation complications delay the complete recovery of critically ill patient. The clinical pathway is one strategies that help to manage and control these complications.
Read the detailed description
The presence of endotracheal tube is associated with various fatal complications which are diagnosed mainly in post- extubation time. Those complications include laryngeal edema, laryngospasm, and post-extubation dysphagia which delay the complete recovery of critically ill patient. The clinical pathway is one of the excellent strategies that help the critical care staff to manage and control these complications
- Conditions
- Dysphagia, Dysphagia Rehabilitation
- Being tested
- ETT cuff pressure monitoring, ETT suctioning, cough augmentation technique, swallowing exercises,: Nebulized budesonide 1mg and IV methylprednisolone 40 mg we
- Keywords
- post-extubation dysphagia, post-extubation laryngospasm
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ETT cuff pressure monitoring, ETT suctioning, cough augmentation technique, swallowing exercises,: Nebulized budesonide 1mg and IV methylprednisolone 40 mg weCombination product
cough augmentation, larson maneuver, swallowing rehabilitation
| Study group | Role | What they receive |
|---|---|---|
| non-clinical pathway group | No intervention | non-clinical pathway group who received the routine hospital care. |
| clinical pathway group | Experimental | the clinical pathway group who recieved the CP interventions such as: ETTcuff pressure measurement, ETT suctioning, measures to prevent laryngeal edema, swallowing rehabilitation, maneuvers to prevent laryngospasm |
What is being measured
The primary outcome is the main question the study is designed to answer.
prevention of laryngeal edema
measured by respiratory distress observation score that it ranges from 0-16. the high score indicates sever respiratory distress
Measured: 72 hours after extubation
laryngospasm
measured by four point scale. it composed from 4 grades, grade 0 indicates no laryngospasm, grade 3 indicates severe degree of laryngospasm.
Measured: 72 hours after extubation
dysphagia
measured by Gugging Swallowing Screen scale that it ranges from 0 -20. the high score indicates severe dysphagia
Measured: 72 hours after extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2025
- Study start8 Aug 2024
- Primary completion8 Mar 2025
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysphagiaStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- non- clinical pathway group and clinical pathway group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Damanhour University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heba.Attia@nur.dmu.edu.eg, Damanhour University
- Investigators
- sahar youness effect of adult intubated CP on post-extubation complications, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07081399
- Sponsor's protocol ID
- 1a2b3c4d5e6f7g8h9i10j11k12l13m
- Acronym
- CP
- Status last verified
- Jul 2025
- First submitted
- 2 Jan 2025
- Last updated
- 23 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Effect of Adult Intubated Patient Clinical Pathway on Post-extubation Complications Prevention
- ClinicalTrials.gov ID
- NCT07081399
- Acronym / sponsor ID
- CP / 1a2b3c4d5e6f7g8h9i10j11k12l13m
- Conditions
- Dysphagia, Dysphagia Rehabilitation
- Keywords
- post-extubation dysphagia, post-extubation laryngospasm
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Damanhour UniversityUniversity, hospital or other
- Study start
- 8 Aug 2024 (actual)
- Primary completion
- 8 Mar 2025 (actual)
- Study completion
- Aug 2025 (estimated)
- First posted
- 23 Jul 2025 (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.
Post- extubation complications delay the complete recovery of critically ill patient. The clinical pathway is one strategies that help to manage and control these complications.
Detailed description
The presence of endotracheal tube is associated with various fatal complications which are diagnosed mainly in post- extubation time. Those complications include laryngeal edema, laryngospasm, and post-extubation dysphagia which delay the complete recovery of critically ill patient. The clinical pathway is one of the excellent strategies that help the critical care staff to manage and control these complications
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- non- clinical pathway group and clinical pathway group
| Arm | Type | Receives |
|---|---|---|
| non-clinical pathway group | No intervention | –non-clinical pathway group who received the routine hospital care. |
| clinical pathway group | Experimental | –the clinical pathway group who recieved the CP interventions such as: ETTcuff pressure measurement, ETT suctioning, measures to prevent laryngeal edema, swallowing rehabilitation, maneuvers to prevent laryngospasm |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Adult (>18 years)
- orally intubated patients for the first time attached with MV for less than two weeks
- with Glasgow coma scale (GCS) from 13-15.
Key exclusion criteria (5 listed)
- patients admitted with high risk for laryngeal edema,
- difficult intubation,
- ETT/anterior-posterior diameter ˃45%,
- self-extubation, and
- planned for tracheostomy.
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 |
|---|---|---|
| ETT cuff pressure monitoring, ETT suctioning, cough augmentation technique, swallowing exercises,: Nebulized budesonide 1mg and IV methylprednisolone 40 mg wecough augmentation, larson maneuver, swallowing rehabilitation | Combination product | – |
Primary outcome
prevention of laryngeal edema
Time frame: 72 hours after extubation
measured by respiratory distress observation score that it ranges from 0-16. the high score indicates sever respiratory distress
laryngospasm
Time frame: 72 hours after extubation
measured by four point scale. it composed from 4 grades, grade 0 indicates no laryngospasm, grade 3 indicates severe degree of laryngospasm.
dysphagia
Time frame: 72 hours after extubation
measured by Gugging Swallowing Screen scale that it ranges from 0 -20. the high score indicates severe dysphagia
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2025.
- Individual participant dataSharing planned: No
Related trials for Dysphagia
RecruitingObservational study
A Study to Evaluate the Efficacy and Safety of Long-term Administration of K-CAB Tab./K-CAB ODT(Tegoprazan) 25 mg as Maintenance Therapy Following the Treatment of GERD
Maintenance Therapy Following Treatment for Gastroesophageal Reflux Disease(GERD)
Recruiting
The Esophageal String Test as a Diagnostic Screening Tool for Eosinophilic Esophagitis Among Africans With Dysphagia in Mali and the United States
Dysphagia, Eosinophilic Esophagitis
Recruiting
taVNS in Infants Severe Dysphagia
Dysphagia, Swallowing Disorders
Not yet recruitingPhase 2
Early Feeding TL Trial
Total Laryngectomy
Active, not recruitingObservational study
RETHINK REFLUX Registry
Gastroesophageal Reflux
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.
heba attia effect of adult intubated CP on post-extubation complications contact
sahar youness effect of adult intubated CP on post-extubation complications study chair
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing ETT cuff pressure monitoring, ETT suctioning, cough augmentation technique, swallowing exercises,: Nebulized budesonide 1mg and IV methylprednisolone 40 mg we in people with Dysphagia and Dysphagia Rehabilitation, run by Damanhour University at 1 site in Egypt.
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 3 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 23 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact heba attia effect of adult intubated CP on post-extubation complications (045 01274855242, heba.attia@nur.dmu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prevention of laryngeal edema (time frame: 72 hours after extubation). The study lists 3 primary outcomes in all. 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 23 Jul 2025.