Predicting Post Extubation Stridor After Maxillomandibular Fixation

Not Applicable

Recruiting

• Conditions: Stridor; Larynx Edema
• Interventions: Drug: normal saline; Drug: budesonide

• Registration Number: NCT05839756
• Lead Sponsor: Mansoura University

Brief 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)

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 Timeline

• Study First Submitted: 2023-04-21
• Study First Submitted QC: 2023-05-01
• Study Start: 2023-05-03
• Study First Posted: 2023-05-03
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-05
• Last Update Posted: 2024-02-06
• Primary Completion: 2025-02-25
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 62

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control (C) group	normal saline	normal saline will be nebulized
Budesonide (B) group	budesonide	budesonide will be nebulized

Primary Outcome Measures

Name	Time	Method
Laryngeal air column width ratio	immediately before extubation

Secondary Outcome Measures

Name	Time	Method
endotracheal tube insertion depth	immediately after intubation	cm
Expiratory tidal volume immediate after intubation with the cuff inflated	immediately after intubation	ml
The duration of nasal endotracheal intubation	Procedure (from nasal endotracheal intubation till extubation)	min
The incidence of epistasis occurrence during nasotracheal intubation	immediately after intubation	4-point verbal descriptor scale (0=no symptoms, 1=mild, 2=moderate, 3=severe)

Trial Locations

Locations (1)

Maha Ahmed AboZeid; 🇪🇬 Mansoura, Egypt