Predicting breathing difficulties after jaw surgery
Predicting Post Extubation Stridor in Patients With Intermaxillary Fixation
This study is testing if using ultrasound and a simple breathing test can help doctors predict which patients might have trouble breathing after jaw surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 62 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mansoura University Academic / other |
| Locations | 1 site (Al Mansurah, Mansoura) |
| Trial ID | NCT05839756 on ClinicalTrials.gov |
What this trial studies
This study aims to identify patients at risk of developing post-extubation stridor, a condition characterized by noisy breathing due to airway narrowing after surgery. It utilizes ultrasound to measure laryngeal morphology and assess the laryngeal air-column width, which can help predict the likelihood of stridor. Additionally, the cuff-leak test will be employed to evaluate the risk of stridor based on the difference in tidal volume with the cuff inflated versus deflated. The goal is to enhance patient safety during recovery from maxillomandibular fixation surgeries.
Who should consider this trial
Good fit: Ideal candidates are adult patients over 18 years old undergoing elective maxillomandibular fixation surgeries under general anesthesia.
Not a fit: Patients with certain medical conditions, such as neuromuscular diseases or uncontrolled diabetes, or those who have had recent upper airway infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved prediction and management of post-extubation stridor, enhancing patient safety and recovery outcomes.
How similar studies have performed: While the use of ultrasound for laryngeal assessment is established, the specific predictive approach in this study is novel and has not been extensively tested in similar contexts.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Al Mansurah, Mansoura
- Maha Ahmed AboZeid — Al Mansurah, Mansoura, Egypt (Recruiting)
Study contacts
- Study coordinator: Maha A AboZeid, MD
- Email: mahazed@yahoo.com
- Phone: 02-01019216192
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.