Predicting Post Extubation Stridor After Maxillomandibular Fixation

Study Overview
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Brief Summary
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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
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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.

Official Title
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Predicting Post Extubation Stridor in Patients With Intermaxillary Fixation

Conditions
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Stridor, Larynx Edema

Intervention / Treatment
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* Drug: budesonide
* Drug: normal saline


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients will be randomly allocated into two equal groups via opaque coded envelopes
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: control (C) group<br>normal saline will be nebulized | Drug: normal saline<br>* 5 ml normal saline will be nebulized preoperatively<br>|
| Active Comparator: Budesonide (B) group<br>budesonide will be nebulized | Drug: budesonide<br>* 2 ml nebulized budesonide (containing 1 mg) diluted in 3 ml of normal saline will be nebulized preoperatively<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Laryngeal air column width ratio |  | immediately before extubation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The duration of nasal endotracheal intubation | min | Procedure (from nasal endotracheal intubation till extubation) | 
| endotracheal tube insertion depth | cm | 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) | immediately after intubation | 
| Expiratory tidal volume immediate after intubation with the cuff inflated | ml | immediately after intubation |