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Completed

NCT Number: NCT06981923

Awake Video Stylet Airway Assessment and Evaluation of Tracheal Intubation With CMAC D-Blade Versus 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

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.

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. Duration of the successful intubation attempt

    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. Number of intubation attempts

    Time frame: At the time of the procedure

    Number of trials of intubation will be recorded during the procedure.

  3. 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.

  4. Cormack-Lehane Classification and percentage of glottic view

    Time frame: 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.

  5. Video classification of intubation (VCI)

    Time frame: At the time of the procedure

    Video classification of intubation score will be assessed and recorded during intubation after induction of anesthesia.

  6. 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.

  7. Stress response of intubation

    Time frame: At the time of the procedure

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

  8. Heart rate

    Time frame: At the time of the procedure

    Heart rate will be assessed before and after intubation (beats per minute)

  9. Mean arterial blood pressure (MAP)

    Time frame: 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)

  10. 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)

  11. 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).

  12. Patient satisfaction

    Time frame: At the time of the procedure

    Patient satisfaction will be assessed using Likert scale.

    Common 5-Point Scale Options:

    • Very dissatisfied
    • Dissatisfied
    • Neutral
    • Satisfied
    • Very satisfied

Sponsors and collaborators

Lead sponsor

General Committee of Teaching Hospitals and Institutes, Egypt

Other Gov

Registry information

Official study title

Awake Video Stylet Airway Assessment and Evaluation of Tracheal Intubation With CMAC D-Blade Versus Video Stylet in Bariatric Surgery: A Prospective Comparative Randomized Study.

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 21, 2025
Registry last updated
Aug 31, 2026

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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