Clinical trial NCT06981923: Awake Bedside Assessment of The Airway and Evaluation of Tracheal Intubation With CMAC D-Blade or Video Stylet in Bariatric Surgery
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Difficult Intubation in Obesity
Keywords: CMAC D-Blade
CMAC Video-style
bariatric patients
Simplified Airway Risk Index (SARI)
Lead sponsor: General Committee of Teaching Hospitals and Institutes, Egypt
Sponsor class: OTHER_GOV
First posted: 2025-05-21
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: SUPPORTIVE_CARE

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: 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.

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.

Primary outcomes:
measure: First-Pass Success Rate
timeFrame: At the time of the procedure
Secondary outcomes:
measure: Time to Intubation
timeFrame: At the time of the procedure
measure: Intubation Difficulty Score (IDS)
timeFrame: At the time of the procedure
measure: Stress response of intubation
timeFrame: At the time of the procedure
measure: awake Cormack-Lehane Classification
timeFrame: At the time of the procedure
measure: Operator satisfaction
timeFrame: At the time of the procedure
measure: Complications
timeFrame: At the time of the procedure
measure: Need for Alternative Intubation Devices
timeFrame: At the time of the procedure
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Madina Women's Hospital
city: Alexandria
country: Egypt
facility: The surgical department of Medical Research Institute Hospital, Alexandria University
Study officials:
References: