Larynx Edema, Stridor
Conditions
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.
Interventions
DRUGbudesonide
2 ml nebulized budesonide (containing 1 mg) diluted in 3 ml of normal saline will be nebulized preoperatively
DRUGnormal saline
5 ml normal saline will be nebulized preoperatively
Sponsors
Mansoura University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Masking description
The preoperative aerosolized drug will be applied by an anesthetist who is not involved in further patient care
Intervention model description
Patients will be randomly allocated into two equal groups via opaque coded envelopes
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Laryngeal air column width ratio | immediately before extubation | % |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The duration of nasal endotracheal intubation | Procedure (from nasal endotracheal intubation till extubation) | min |
| endotracheal tube insertion depth | immediately after intubation | cm |
| 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) |
| Expiratory tidal volume immediate after intubation with the cuff inflated | immediately after intubation | ml |
Countries
Egypt
Contacts
CONTACTMaha A AboZeid, MD
Outcome results
None listed