Predicting Post Extubation Stridor After Maxillomandibular Fixation

Stridor Clinical Trial

— airway  

Official title:

Predicting Post Extubation Stridor in Patients With Intermaxillary Fixation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05839756
• Other study ID #: Post Extubation Stridor
• Status: Recruiting
• Phase: N/A
• Start date: May 3, 2023
• Est. completion date: June 30, 2025

Study information

• Verified date: February 2024
• Source: Mansoura University
• Contact: Maha A AboZeid, MD
• Phone: 02-01019216192
• Email: mahazed[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 62
• Est. completion date: June 30, 2025
• Est. primary completion date: February 25, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Respiratory Sounds
• Stridor

Intervention

Drug:
• budesonide
2 ml nebulized budesonide (containing 1 mg) diluted in 3 ml of normal saline will be nebulized preoperatively
• normal saline
5 ml normal saline will be nebulized preoperatively

Locations

Country	Name	City	State
Egypt	Maha Ahmed AboZeid	Mansoura

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Expiratory tidal volume immediate after intubation with the cuff deflated	ml	immediately after intubation
Other	Expiratory tidal volume immediate before extubation with the cuff inflated	ml	immediately before extubation
Other	Expiratory tidal volume immediate before extubation with the cuff deflated	ml	immediately before extubation
Other	cuff leak volume	ml	immediate after intubation and immediate before extubation
Other	Laryngeal air column width	mm	before intubation
Other	Laryngeal air column width	mm	immediate after intubation during the balloon-cuff inflation and during balloon-cuff deflation
Other	Laryngeal air column width	mm	immediate before extubation during the balloon-cuff inflation and during balloon-cuff deflation
Other	Laryngeal air column width difference	mm	immediate after intubation and immediate before extubation
Other	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
Primary	Laryngeal air column width ratio		immediately before extubation
Secondary	The duration of nasal endotracheal intubation	min	Procedure (from nasal endotracheal intubation till extubation)
Secondary	endotracheal tube insertion depth	cm	immediately after intubation
Secondary	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
Secondary	Expiratory tidal volume immediate after intubation with the cuff inflated	ml	immediately after intubation