Predicting Post Extubation Stridor After Maxillomandibular Fixation (airway)

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)

Study Overview

• Status: Recruiting
• Conditions: Stridor; Larynx Edema
• Intervention / Treatment: Drug: normal saline; Drug: budesonide

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 Type: Interventional
• Enrollment (Estimated): 62
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maha A AboZeid, MD; Phone Number: 02-01019216192; Email: mahazed@yahoo.com

Study Locations

• Egypt
  • Mansoura, Egypt, 35511
    • Recruiting
    • Maha Ahmed AboZeid
    • Contact: Maha A AboZeid; Email: mahazed@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Expiratory tidal volume immediate after intubation with the cuff deflated	ml	immediately after intubation
Expiratory tidal volume immediate before extubation with the cuff inflated	ml	immediately before extubation
Expiratory tidal volume immediate before extubation with the cuff deflated	ml	immediately before extubation
cuff leak volume	ml	immediate after intubation and immediate before extubation
Laryngeal air column width	mm	before intubation
Laryngeal air column width	mm	immediate after intubation during the balloon-cuff inflation and during balloon-cuff deflation
Laryngeal air column width	mm	immediate before extubation during the balloon-cuff inflation and during balloon-cuff deflation
Laryngeal air column width difference	mm	immediate after intubation and immediate before extubation
incidence of postoperative sore throat, dysphonia, swallowing disorders or PES.	4-point verbal descriptor scale (0=no symptoms, 1=mild, 2=moderate, 3=severe)	First postoperative day

Collaborators and Investigators

• Sponsor: Mansoura University

Study record dates

Study Major Dates

• Study Start (Actual): May 3, 2023
• Primary Completion (Estimated): February 25, 2025
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: April 21, 2023
• First Submitted That Met QC Criteria: May 1, 2023
• First Posted (Actual): May 3, 2023

Study Record Updates

• Last Update Posted (Estimated): February 6, 2024
• Last Update Submitted That Met QC Criteria: February 5, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory; Respiratory Sounds; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Budesonide
• Other Study ID Numbers: Post Extubation Stridor

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No