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Completed
NCT06981923
Awake Video Stylet Airway Assessment and Evaluation of Tracheal Intubation With CMAC D-Blade Versus Video Stylet in Bariatric Surgery
Conditions: Difficult Intubation in Obesity
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 350
Sponsor: General Committee of Teaching Hospitals and Institutes, Egypt
Location: Madina Women's Hospital Alexandria
Summary
Patients undergoing bariatric surgery often present challenges during intubation due to limited neck mobility, increased soft tissue in the airway, and elevated body mass index (BMI). Predicting difficult intubation in these patients is critical to ensuring safety. The Simplified Airway Risk Index (SARI) by Ganzouri is a validated tool for predicting difficult intubation. It considers factors like neck mobility, Mallampati score, and body weight, which are highly relevant in difficult airway prediction in the bariatric population.
The CMAC video laryngoscope is widely used to manage difficult airways. Two commonly used devices are the CMAC D-Blade, designed explicitly for difficult airways, and the CMAC Video stylet, which combines video guidance with a flexible tip. This study will compare the efficacy and safety of these two devices in bariatric patients with an anticipated difficult airway, as identified by the SARI.
Eligibility Criteria
Inclusion Criteria:
* Adult patients (≥ 18 years)
* BMI ≥ 35 kg/m²
* SARI score ≥ 4
* Scheduled for elective bariatric surgery
Exclusion Criteria:
1. SARI score \< 4.
2. any known or suspected airway pathology (such as tumors, airway trauma, or history of airway surgery/tracheostomy).
3. Emergency surgery.
4. Coagulopathy.
5. seizures, pregnancy,
6. mouth opening ≤ 2 cm.
7. contraindications to general anesthesia or neuromuscular blockade and uncooperative patients.
Source: ClinicalTrials.gov (NCT06981923). StuddyBuddy aggregates publicly available trial information.