Comparing methods to assess laryngeal swelling during spinal surgery
Comparison of Conventional and Manometry Measurement Methods in the Evaluation of Perioperative Laryngeal Edema by USG in Patients Undergoing Lumbar Stabilization Surgery
NA · Fatih Sultan Mehmet Training and Research Hospital · NCT06770322
This study is testing two different ways to measure swelling in the throat of patients having back surgery to see if one method helps doctors better manage complications after surgery.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Fatih Sultan Mehmet Training and Research Hospital (other) |
| Locations | 1 site (Istanbul, Atasehir) |
| Trial ID | NCT06770322 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effects of two different methods for measuring laryngeal edema in patients undergoing lumbar stabilization surgery while positioned prone. The investigators will use conventional techniques and manometry measurement methods alongside ultrasonography to assess perioperative complications related to laryngeal edema. The aim is to improve patient outcomes by identifying and addressing potential complications during the postoperative period.
Who should consider this trial
Good fit: Ideal candidates are patients aged 18-65 who are scheduled for elective lumbar spinal surgery under general anesthesia and are classified as ASA I-III.
Not a fit: Patients over 65 years of age, those with significant comorbidities, or those with a history of specific upper airway surgeries may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better management of laryngeal edema, reducing complications and improving recovery for patients undergoing lumbar spinal surgery.
How similar studies have performed: While there is limited data on this specific approach, similar studies have shown promise in managing laryngeal edema during surgical procedures.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients who will undergo lumbar spinal surgery under general anesthesia under elective conditions * Patients aged 18-65 years, included in the ASA I-III group * Patients whose consent has been obtained Exclusion Criteria: * Patients under 18 years of age, over 65 years of age, included in the ASA IV-V group * Patients with a history of surgery in the oral cavity, including direct laryngoscopy and biopsy, microlaryngoscopic surgery, tonsillectomy, adenoidectomy, soft palate, oropharynx, hypopharynx, larynx and trachea, * Patients with a history of allergies, asthma, reflux, upper respiratory viral or fungal infections and cancer surgeries, * Patients receiving radiotherapy to the neck who had multiple intubation attempts in the previous year, * Patients undergoing emergency surgery, * Patients with advanced cardiac, renal, pulmonary and hepatic failure, * Patients who did not give consent to participate in the study.
Where this trial is running
Istanbul, Atasehir
- Fatih Sultan Mehmet Training and Research Hospital — Istanbul, Atasehir, Turkey (RECRUITING)
Study contacts
- Study coordinator: Berkehan M Nizamlioglu
- Email: bnzmoglu@gmail.com
- Phone: +905071400092
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.
Conditions: Spinal Stabilization, ultrasonography, laryngeal edema, endotracheal cuff, lumbar spinal stabilization surgery