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

General Committee of Teaching Hospitals and Institutes, Egypt

Status: Not yet enrolling

Conditions: Difficult Intubation in Obesity

Treatments: Device: CMAC Video Stylet; Device: CMAC D-Blade

Study type: Interventional

Funder types: Other

Identifiers

NCT06981923

CMAC D-Blade or Video Stylet

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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150 participants in 2 patient groups

CMAC D-Blade Group

Active Comparator group

Description:

Intubation will be performed using the CMAC D-Blade

Treatment:

Device: CMAC D-Blade

CMAC Video Style Group

Active Comparator group

Description:

Intubation will be performed using the CMAC Video stylet

Treatment:

Device: CMAC Video Stylet