Difficult Intubation in Obesity
Conditions
Keywords
CMAC D-Blade, CMAC Video-style, bariatric patients, Simplified Airway Risk Index (SARI)
Brief 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
Standard monitoring will be attached. Preoperative awake airway assessment: after airway topicalization, CMAC Video stylet will be used for airway assessment, and the Cormack and Leane and percentage of glottic view 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.
Interventions
DEVICECMAC D-Blade
Intubation will be performed using the CMAC D-Blade
DEVICECMAC Video Stylet
Intubation will be performed using the CMAC Video stylet
Sponsors
General Committee of Teaching Hospitals and Institutes, Egypt
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Intervention model description
Intervention Groups 1. CMAC D-Blade Group: Intubation will be performed using the CMAC D-Blade. 2. CMAC Video Style Group: Intubation will be performed using the CMAC Video stylet.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| First-Pass Success Rate | At the time of the procedure | This is a successful intubation on the first attempt without needing an alternative device. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of the successful intubation attempt | At the time of the procedure | Measured from the insertion of the device into the mouth until confirmation of endotracheal tube placement via capnography. |
| Number of intubation attempts | At the time of the procedure | Number of trials of intubation will be recorded during the procedure. |
| Intubation Difficulty Score (IDS) | At the time of the procedure | A composite score based on multiple intubation-related factors, such as the number of attempts, additional maneuvers, and the application of external laryngeal pressure. |
| Cormack-Lehane Classification and percentage of glottic view | At the time of the procedure | Cormack-Lehane Classification and percentage of glottic view will be assessed during the awake airway assessment and after induction of anesthesia during the intubation process. |
| Video classification of intubation (VCI) | At the time of the procedure | Video classification of intubation score will be assessed and recorded during intubation after induction of anesthesia. |
| Need for Alternative Intubation Devices | At the time of the procedure | Documentation of cases where the initially assigned device failed, and an alternative was needed. |
| Stress response of intubation | At the time of the procedure | serum level of stress markers measured before and after intubation (catecholamines) |
| Heart rate | At the time of the procedure | Heart rate will be assessed before and after intubation (beats per minute) |
| Mean arterial blood pressure (MAP) | At the time of the procedure | Mean arterial pressure (MAP) is the average blood pressure in a person's arteries during one complete cardiac cycle. Mean arterial blood pressure will be assessed before and after intubation. Calculation Formula: (systolic blood pressure plus two times diastolic blood pressure) divided by 3. (In millimeters mercury) |
| Complications | At the time of the procedure | for example, 1. Hypoxemia (SpO₂ \< 92%) 2. Esophageal intubation or failed intubation 3. Airway trauma (dental or oropharyngeal injury) |
| Operator satisfaction | At the time of the procedure | 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). |
| Patient satisfaction | At the time of the procedure | Patient satisfaction will be assessed using Likert scale. Common 5-Point Scale Options: 1. Very dissatisfied 2. Dissatisfied 3. Neutral 4. Satisfied 5. Very satisfied |
Countries
Egypt
Outcome results
None listed