NCT06981923

Awake Bedside Assessment of The Airway and Evaluation of Tracheal Intubation With CMAC D-Blade or Video Stylet in Bariatric Surgery

Awake Bedside Assessment of The Airway and Evaluation of Tracheal Intubation With CMAC D-Blade or Video Stylet in Bariatric Surgery: A Randomized Comparative Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: General Committee of Teaching Hospitals and Institutes, Egypt · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Comparing the effectiveness and safety of the CMAC D-Blade versus the CMAC Video-style for awake bedside airway assessment and their performance during tracheal intubation in bariatric patients with expected difficult intubation as predicted by the Simplified Airway Risk Index (SARI). Standard monitoring will be attached and recorded. Preoperative awake airway assessment: after airway topicalization, both devices will be used for airway assessment according to the group allocation, and the Cormack and Leane will be recorded. Induction of Anesthesia: A standardized protocol will be followed for all patients, including preoxygenation and administration of propofol, fentanyl, and muscle relaxants (e.g., rocuronium). Intubation: The intubating anesthetist will use the assigned device. \- Rescue Strategy: If intubation fails after three attempts or exceeds 120 seconds, the anesthetist will switch to an alternative device or follow the institutional difficult airway protocol.

Conditions

• Difficult Intubation in Obesity

Interventions

Type	Name	Description
DEVICE	CMAC D-Blade	Intubation will be performed using the CMAC D-Blade
DEVICE	CMAC Video Stylet	Intubation will be performed using the CMAC Video stylet

Timeline

• Start date: 2025-05-10
• Primary completion: 2025-09-10
• Completion: 2025-09-22
• First posted: 2025-05-21
• Last updated: 2025-10-07

Locations

2 sites across 1 country: Egypt