Predicting Post Extubation Stridor After Maxillomandibular Fixation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: budesonide, normal saline.
- Who it may be relevant to
- Registry conditions: Stridor, Larynx Edema. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Predicting Post Extubation Stridor in Patients With Intermaxillary Fixation
Overview
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.
Interventions
- Drug budesonide
2 ml nebulized budesonide (containing 1 mg) diluted in 3 ml of normal saline will be nebulized preoperatively - Drug normal saline
5 ml normal saline will be nebulized preoperatively
Primary outcome measures
- Laryngeal air column width ratio [Time frame: immediately before extubation]
Secondary outcome measures (4)
- 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]
Eligibility criteria
Inclusion criteria
- Adult patients (>18 years)
- American Society of Anesthesiologists status I and II
- undergoing elective maxillomandibular fixation surgeries under general anesthesia with nasal endotracheal intubation
Exclusion criteria
- patients' refusal
- pregnant females
- patients with body mass index <18.5 or ≥ 35 kg/m2
- risk of aspiration
- cardiorespiratory disorder
- neuromuscular disease
- 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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Prevention
Study locations
Egypt · 1 center
- Maha Ahmed AboZeid — Al Mansurah
Identifiers
NCT: NCT05839756 · Post Extubation Stridor