StridorairwayNCT05839756
Predicting Post Extubation Stridor After Maxillomandibular Fixation
A study testing budesonide and normal saline in people with Stridor and Larynx Edema, run by Mansoura University at 1 site in Egypt.
Trial summary
Endotracheal intubation can induce laryngotracheal injury which results in narrowing of the airway due to edema of the glottis. This can increase the risk of development of post-extubation stridor (PES) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stridor, Larynx Edema
- What is being tested?
- budesonide and normal saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 1 siteEgypt
- Study dates
- 3 May 2023to 30 Jun 2028
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (>18 years)
- American Society of Anesthesiologists status I and II
- undergoing elective maxillomandibular fixation surgeries under general anesthesia with nasal endotracheal intubation
Who cannot join
- patients' refusal
- pregnant females
- patients with body mass index <18.5 or ≥ 35 kg/m2
- risk of aspiration
- cardiorespiratory disorder
- neuromuscular disease
Show all 12Show fewer
- uncontrolled diabetes mellitus
- gastrointestinal bleeding
- on chronic steroid therapy
- intubated patients or were intubated or had upper airway infection within 1 week prior to surgery
- history of any pathology, radiotherapy or surgery in the neck
- had difficult laryngeal US plane (as neck wound)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Maha Ahmed AboZeid
Al Mansurah, Mansoura, 35511
Maha A AboZeid, mahazed@yahoo.com
About this study
Official title: Predicting Post Extubation Stridor in Patients With Intermaxillary Fixation
Endotracheal intubation can induce laryngotracheal injury which results in narrowing of the airway due to edema of the glottis. This can increase the risk of development of post-extubation stridor (PES)
Read the detailed description
Ultrasound (US) is a useful and non-invasive tool for the evaluation of vocal cords and laryngeal morphology in intubated patients. The laryngeal air-column width (LACW), Laryngeal air column width difference (LACWD), and laryngeal air-column width ratio (LACWR) measured by ultrasound can potentially identify patients at risk of post-extubation stridor, in whom caution should be taken after extubation.
The cuff-leak test can predict successful extubation through using the difference between the expired tidal volume with the cuff inflated and with the cuff deflated; the higher the leak, the lower the likelihood that post-extubation stridor will occur.
- Conditions
- Stridor, Larynx Edema
- Being tested
- budesonide, normal saline
- Medical subject headings
- Respiratory Sounds, Laryngeal Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
budesonideDrug
2 ml nebulized budesonide (containing 1 mg) diluted in 3 ml of normal saline will be nebulized preoperatively
normal salineDrug
5 ml normal saline will be nebulized preoperatively
| Study group | Role | What they receive |
|---|---|---|
| control (C) group | Placebo comparator | normal saline will be nebulized Receives: Drug: normal saline |
| Budesonide (B) group | Active comparator | budesonide will be nebulized Receives: Drug: budesonide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Laryngeal air column width ratio
%
Measured: immediately before extubation
Secondary outcomes (4)
The duration of nasal endotracheal intubation
min
Measured: Procedure (from nasal endotracheal intubation till extubation)
endotracheal tube insertion depth
cm
Measured: immediately after intubation
The incidence of epistasis occurrence during nasotracheal intubation
4-point verbal descriptor scale (0=no symptoms, 1=mild, 2=moderate, 3=severe)
Measured: immediately after intubation
Expiratory tidal volume immediate after intubation with the cuff inflated
ml
Measured: immediately after intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start3 May 2023
- Primary completion25 Feb 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StridorStudies 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
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomly allocated into two equal groups via opaque coded envelopes
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, maha abou-zeid, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05839756
- Sponsor's protocol ID
- Post Extubation Stridor
- Acronym
- airway
- Status last verified
- Feb 2026
- First submitted
- 21 Apr 2023
- Last updated
- 17 Feb 2026
- 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 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting Post Extubation Stridor in Patients With Intermaxillary Fixation
- ClinicalTrials.gov ID
- NCT05839756
- Acronym / sponsor ID
- airway / Post Extubation Stridor
- Conditions
- Stridor, Larynx Edema
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 3 May 2023 (actual)
- Primary completion
- 25 Feb 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 3 May 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.
Endotracheal intubation can induce laryngotracheal injury which results in narrowing of the airway due to edema of the glottis. This can increase the risk of development of post-extubation stridor (PES)
Detailed description
Ultrasound (US) is a useful and non-invasive tool for the evaluation of vocal cords and laryngeal morphology in intubated patients. The laryngeal air-column width (LACW), Laryngeal air column width difference (LACWD), and laryngeal air-column width ratio (LACWR) measured by ultrasound can potentially identify patients at risk of post-extubation stridor, in whom caution should be taken after extubation.
The cuff-leak test can predict successful extubation through using the difference between the expired tidal volume with the cuff inflated and with the cuff deflated; the higher the leak, the lower the likelihood that post-extubation stridor will occur.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Patients will be randomly allocated into two equal groups via opaque coded envelopes
| Arm | Type | Receives |
|---|---|---|
| control (C) group | Placebo comparator | Drug: normal salinenormal saline will be nebulized |
| Budesonide (B) group | Active comparator | Drug: budesonidebudesonide will be nebulized |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients (>18 years)
- American Society of Anesthesiologists status I and II
- undergoing elective maxillomandibular fixation surgeries under general anesthesia with nasal endotracheal intubation
Key exclusion criteria (12 listed)
- patients' refusal
- pregnant females
- patients with body mass index <18.5 or ≥ 35 kg/m2
- risk of aspiration
- cardiorespiratory disorder
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 |
|---|---|---|
| budesonide2 ml nebulized budesonide (containing 1 mg) diluted in 3 ml of normal saline will be nebulized preoperatively | Drug | Budesonide (B) group |
| normal saline5 ml normal saline will be nebulized preoperatively | Drug | control (C) group |
Primary outcome
Laryngeal air column width ratio
Time frame: immediately before extubation
%
4 secondary outcomes
The duration of nasal endotracheal intubation
Time frame: Procedure (from nasal endotracheal intubation till extubation)
endotracheal tube insertion depth
Time frame: immediately after intubation
The incidence of epistasis occurrence during nasotracheal intubation
Time frame: immediately after intubation
Expiratory tidal volume immediate after intubation with the cuff inflated
Time frame: immediately after intubation
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 17 Feb 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing budesonide and normal saline in people with Stridor and Larynx Edema, run by Mansoura 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 12 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 17 Feb 2026. 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. Some participants in this study may receive a placebo. 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?
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 Maha A AboZeid, MD (02-01019216192, mahazed@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Laryngeal air column width ratio (time frame: immediately before extubation). 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 17 Feb 2026.