Predicting Post Extubation Stridor After Maxillomandibular Fixation (airway)

Mansoura University

Status: Enrolling

Conditions: Stridor; Larynx Edema

Treatments: Drug: budesonide; Drug: normal saline

Study type: Interventional

Funder types: Other

Identifiers

NCT05839756

Post Extubation Stridor

Details and patient eligibility

About

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)

Full 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.

Enrollment: 62 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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62 participants in 2 patient groups, including a placebo group

control (C) group

Placebo Comparator group

Description:

normal saline will be nebulized

Treatment:

Drug: normal saline

Budesonide (B) group

Active Comparator group

Description:

budesonide will be nebulized

Treatment:

Drug: budesonide