Clinical trial NCT05839756: Predicting Post Extubation Stridor After Maxillomandibular Fixation
Official title: Predicting Post Extubation Stridor in Patients With Intermaxillary Fixation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stridor
Larynx Edema
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2023-05-03
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomly allocated into two equal groups via opaque coded envelopes
Primary purpose: PREVENTION

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Laryngeal air column width ratio
timeFrame: immediately before extubation
Secondary outcomes:
measure: The duration of nasal endotracheal intubation
timeFrame: Procedure (from nasal endotracheal intubation till extubation)
measure: endotracheal tube insertion depth
timeFrame: immediately after intubation
measure: The incidence of epistasis occurrence during nasotracheal intubation
timeFrame: immediately after intubation
measure: Expiratory tidal volume immediate after intubation with the cuff inflated
timeFrame: immediately after intubation
Other outcomes:
measure: Expiratory tidal volume immediate after intubation with the cuff deflated
timeFrame: immediately after intubation
measure: Expiratory tidal volume immediate before extubation with the cuff inflated
timeFrame: immediately before extubation
measure: Expiratory tidal volume immediate before extubation with the cuff deflated
timeFrame: immediately before extubation
measure: cuff leak volume
timeFrame: immediate after intubation and immediate before extubation
measure: Laryngeal air column width
timeFrame: before intubation
measure: Laryngeal air column width
timeFrame: immediate after intubation during the balloon-cuff inflation and during balloon-cuff deflation
measure: Laryngeal air column width
timeFrame: immediate before extubation during the balloon-cuff inflation and during balloon-cuff deflation
measure: Laryngeal air column width difference
timeFrame: immediate after intubation and immediate before extubation
measure: incidence of postoperative sore throat, dysphonia, swallowing disorders or PES.
timeFrame: First postoperative day
Locations:
city: Mansoura
country: Egypt
facility: Maha Ahmed AboZeid
Study officials:
References: