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Difficult Intubation in ObesityNCT06981923

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

A study testing CMAC D-Blade and CMAC Video Stylet in people with Difficult Intubation in Obesity, run by General Committee of Teaching Hospitals and Institutes, Egypt at 2 sites in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Difficult Intubation in Obesity
What is being tested?
CMAC D-Blade and CMAC Video Stylet
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
350 participants
Where
2 sitesEgypt
Study dates
10 May 2025to 26 Feb 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country.

Egypt2 sites

  • Madina Women's Hospital

    Alexandria, 21531

  • The surgical department of Medical Research Institute Hospital, Alexandria University

    Alexandria

Other trials in Egypt

About this study

Official 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.

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.

Read the 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.

Being tested
CMAC D-Blade, CMAC Video Stylet
Keywords
CMAC D-Blade, CMAC Video-style, bariatric patients, Simplified Airway Risk Index (SARI)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CMAC D-BladeDevice

    Intubation will be performed using the CMAC D-Blade

  • CMAC Video StyletDevice

    Intubation will be performed using the CMAC Video stylet

Study groups in NCT06981923
Study groupRoleWhat they receive
CMAC D-Blade GroupActive comparatorIntubation will be performed using the CMAC D-Blade
Receives: Device: CMAC D-Blade
CMAC Video Style GroupActive comparatorIntubation will be performed using the CMAC Video stylet
Receives: Device: CMAC Video Stylet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. First-Pass Success Rate

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

    Measured: At the time of the procedure

Secondary outcomes (12)

  1. Duration of the successful intubation attempt

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

    Measured: At the time of the procedure

  2. Number of intubation attempts

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

    Measured: At the time of the procedure

  3. Intubation Difficulty Score (IDS)

    A composite score based on multiple intubation-related factors, such as the number of attempts, additional maneuvers, and the application of external laryngeal pressure.

    Measured: At the time of the procedure

  4. Cormack-Lehane Classification and percentage of glottic view

    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.

    Measured: At the time of the procedure

  5. Video classification of intubation (VCI)

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

    Measured: At the time of the procedure

  6. Need for Alternative Intubation Devices

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

    Measured: At the time of the procedure

  7. Stress response of intubation

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

    Measured: At the time of the procedure

  8. Heart rate

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

    Measured: At the time of the procedure

  9. Mean arterial blood pressure (MAP)

    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)

    Measured: At the time of the procedure

  10. Complications

    for example,

    1. Hypoxemia (SpO₂ < 92%)
    2. Esophageal intubation or failed intubation
    3. Airway trauma (dental or oropharyngeal injury)

    Measured: At the time of the procedure

  11. Operator satisfaction

    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).

    Measured: At the time of the procedure

  12. Patient satisfaction

    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

    Measured: At the time of the procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 May 2025
  2. Study start10 May 2025
  3. Primary completion10 Feb 2026
  4. Study completion26 Feb 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
Single blind
Who is masked
Participant
Enrolment
350 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06981923
Sponsor's protocol ID
CMAC D-Blade vs Video Stylet
Status last verified
Aug 2026
First submitted
11 May 2025
Last updated
31 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The analysis will be performed on a blinded dataset after completing the medical/scientific review. All protocol violations will be identified and resolved, and the dataset will be declared complete. All data will be collected in a data management system (Castor EDC, Amsterdam, The Netherlands; https://www.castoredc.com), handled according to Good Clinical Practice guidelines, Data Protection Directive certificate, and complied with Title 21 CFR Part 11. Furthermore, the data centers where all the research data will be stored are certified according to ISO27001, ISO9001, and Dutch NEN7510. Can be asked by the contact person

Questions about this trial

What is this clinical trial studying?

A study testing CMAC D-Blade and CMAC Video Stylet in people with Difficult Intubation in Obesity, run by General Committee of Teaching Hospitals and Institutes, Egypt at 2 sites in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

First-Pass Success Rate (time frame: At the time of the procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06981923.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026.

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