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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CMAC D-Blade Group | Active Comparator | Intubation will be performed using the CMAC D-Blade |
|
| CMAC Video Style Group | Active Comparator | Intubation will be performed using the CMAC Video stylet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CMAC D-Blade | Device | Intubation will be performed using the CMAC D-Blade |
| |
| Measure | Description | Time Frame |
|---|---|---|
| First-Pass Success Rate | This is a successful intubation on the first attempt without needing an alternative device. | At the time of the procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Intubation | Measured from the insertion of the device into the mouth until confirmation of endotracheal tube placement via capnography. | At the time of the procedure |
| Intubation Difficulty Score (IDS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Madina Women's Hospital | Alexandria | 21531 | Egypt | |||
| The surgical department of Medical Research Institute Hospital, Alexandria University |
The analysis will be performed on a blinded dataset after completing the medical/scientific review. All protocol violations will be identified and resolved, and the dataset will be declared complete. All data will be collected in a data management system (Castor EDC, Amsterdam, The Netherlands; https://www.castoredc.com), handled according to Good Clinical Practice guidelines, Data Protection Directive certificate, and complied with Title 21 CFR Part 11. Furthermore, the data centers where all the research data will be stored are certified according to ISO27001, ISO9001, and Dutch NEN7510.
Can be asked by the contact person
Whole study period
Ask contact person
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Intervention Groups
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| CMAC Video Stylet |
| Device |
Intubation will be performed using the CMAC Video stylet |
|
A composite score based on multiple intubation-related factors, such as the number of attempts, additional maneuvers, and the application of external laryngeal pressure.
| At the time of the procedure |
| Stress response of intubation | serum level of stress markers measured before and after intubation (catecholamines) | At the time of the procedure |
| awake Cormack-Lehane Classification | awake Cormack-Lehane Classification of Glottic View assessment and after induction of anesthesia during the intubation process. | At the time of the procedure |
| Operator satisfaction | the anesthesiologist rated their satisfaction with the device performance on a 5-point Likert scale (5 = extremely satisfied, 4 = satisfied, 3 = neutral, 2 = dissatisfied, 1 = extremely dissatisfied). | At the time of the procedure |
| Complications | for example,
| At the time of the procedure |
| Need for Alternative Intubation Devices | Documentation of cases where the initially assigned device failed, and an alternative was needed. | At the time of the procedure |
| Alexandria |
| Egypt |