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NCT Number: NCT05839756

Predicting Post Extubation Stridor After Maxillomandibular 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)

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Key information

Conditions

Stridor Laryngeal Diseases Laryngeal Edema Larynx Edema Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Respiratory Sounds Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maha Ahmed AboZeid

Al Mansurah, Mansoura, 35511, Egypt

Location status: Recruiting

Location contact

Maha A AboZeid

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Budesonide

Drug

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

normal saline

Drug

5 ml normal saline will be nebulized preoperatively

Primary outcomes

  1. Laryngeal air column width ratio

    Time frame: immediately before extubation

    %

Secondary outcomes

  1. The duration of nasal endotracheal intubation

    Time frame: Procedure (from nasal endotracheal intubation till extubation)

    min

  2. endotracheal tube insertion depth

    Time frame: immediately after intubation

    cm

  3. The incidence of epistasis occurrence during nasotracheal intubation

    Time frame: immediately after intubation

    4-point verbal descriptor scale (0=no symptoms, 1=mild, 2=moderate, 3=severe)

  4. Expiratory tidal volume immediate after intubation with the cuff inflated

    Time frame: immediately after intubation

    ml

Other outcomes

  1. Expiratory tidal volume immediate after intubation with the cuff deflated

    Time frame: immediately after intubation

    ml

  2. Expiratory tidal volume immediate before extubation with the cuff inflated

    Time frame: immediately before extubation

    ml

  3. Expiratory tidal volume immediate before extubation with the cuff deflated

    Time frame: immediately before extubation

    ml

  4. cuff leak volume

    Time frame: immediate after intubation and immediate before extubation

    ml

  5. Laryngeal air column width

    Time frame: before intubation

    mm

  6. Laryngeal air column width

    Time frame: immediate after intubation during the balloon-cuff inflation and during balloon-cuff deflation

    mm

  7. Laryngeal air column width

    Time frame: immediate before extubation during the balloon-cuff inflation and during balloon-cuff deflation

    mm

  8. Laryngeal air column width difference

    Time frame: immediate after intubation and immediate before extubation

    mm

  9. incidence of postoperative sore throat, dysphonia, swallowing disorders or PES.

    Time frame: First postoperative day

    4-point verbal descriptor scale (0=no symptoms, 1=mild, 2=moderate, 3=severe)

Study contacts

Contact information is provided by the study sponsor or research team.

Maha A AboZeid, MD

CONTACT

[email protected]

02-01019216192

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

Predicting Post Extubation Stridor in Patients With Intermaxillary Fixation

Acronym: airway

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
May 3, 2023
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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