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NCT Number: NCT06981923

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

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.

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Key information

Conditions

Difficult Intubation in Obesity

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Madina Women's Hospital, Alexandria, Egypt

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients (≥ 18 years)
  • BMI ≥ 35 kg/m²
  • SARI score ≥ 4
  • Scheduled for elective bariatric surgery

Exclusion criteria

  • SARI score < 4.
  • any known or suspected airway pathology (such as tumors, airway trauma, or history of airway surgery/tracheostomy).
  • Emergency surgery.
  • Coagulopathy.
  • seizures, pregnancy,
  • mouth opening ≤ 2 cm.
  • contraindications to general anesthesia or neuromuscular blockade and uncooperative patients.

Treatment and study plan

CMAC D-Blade

Device

Intubation will be performed using the CMAC D-Blade

CMAC Video Stylet

Device

Intubation will be performed using the CMAC Video stylet

Primary outcomes

  1. First-Pass Success Rate

    Time frame: At the time of the procedure

    This is a successful intubation on the first attempt without needing an alternative device.

Secondary outcomes

  1. Time to Intubation

    Time frame: At the time of the procedure

    Measured from the insertion of the device into the mouth until confirmation of endotracheal tube placement via capnography.

  2. Intubation Difficulty Score (IDS)

    Time frame: 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.

  3. Stress response of intubation

    Time frame: At the time of the procedure

    serum level of stress markers measured before and after intubation (catecholamines)

  4. awake Cormack-Lehane Classification

    Time frame: At the time of the procedure

    awake Cormack-Lehane Classification of Glottic View assessment and after induction of anesthesia during the intubation process.

  5. Operator satisfaction

    Time frame: 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).

  6. Complications

    Time frame: At the time of the procedure

    for example,

    • Hypoxemia (SpO₂ < 92%)
    • Esophageal intubation or failed intubation
    • Airway trauma (dental or oropharyngeal injury)

  7. Need for Alternative Intubation Devices

    Time frame: At the time of the procedure

    Documentation of cases where the initially assigned device failed, and an alternative was needed.

Sponsors and collaborators

Lead sponsor

General Committee of Teaching Hospitals and Institutes, Egypt

Other Gov

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 21, 2025
Registry last updated
Oct 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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