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.
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
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.
- Conditions
- Difficult Intubation in Obesity
- 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 group | Role | What they receive |
|---|---|---|
| CMAC D-Blade Group | Active comparator | Intubation will be performed using the CMAC D-Blade Receives: Device: CMAC D-Blade |
| CMAC Video Style Group | Active comparator | Intubation 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.
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)
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
Number of intubation attempts
Number of trials of intubation will be recorded during the procedure.
Measured: At the time of the procedure
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
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
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
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
Stress response of intubation
serum level of stress markers measured before and after intubation (catecholamines)
Measured: At the time of the procedure
Heart rate
Heart rate will be assessed before and after intubation (beats per minute)
Measured: At the time of the procedure
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
Complications
for example,
- Hypoxemia (SpO₂ < 92%)
- Esophageal intubation or failed intubation
- Airway trauma (dental or oropharyngeal injury)
Measured: At the time of the procedure
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
Patient satisfaction
Patient satisfaction will be assessed using Likert scale.
Common 5-Point Scale Options:
- Very dissatisfied
- Dissatisfied
- Neutral
- Satisfied
- 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.
- First posted21 May 2025
- Study start10 May 2025
- Primary completion10 Feb 2026
- Study completion26 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Difficult Intubation in ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- General Committee of Teaching Hospitals and Institutes, Egypt
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mohamed Hany Ashour, General Committee of Teaching Hospitals and Institutes, Egypt
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
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06981923
- Acronym / sponsor ID
- CMAC D-Blade vs Video Stylet
- Conditions
- Difficult Intubation in Obesity
- Keywords
- CMAC D-Blade, CMAC Video-style, bariatric patients, Simplified Airway Risk Index (SARI)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- General Committee of Teaching Hospitals and Institutes, EgyptOther government
- Study start
- 10 May 2025 (actual)
- Primary completion
- 10 Feb 2026 (actual)
- Study completion
- 26 Feb 2026 (actual)
- First posted
- 21 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| CMAC D-Blade Group | Active comparator | Device: CMAC D-BladeIntubation will be performed using the CMAC D-Blade |
| CMAC Video Style Group | Active comparator | Device: CMAC Video StyletIntubation will be performed using the CMAC Video stylet |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients (≥ 18 years)
- BMI ≥ 35 kg/m²
- SARI score ≥ 4
- Scheduled for elective bariatric surgery
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CMAC D-BladeIntubation will be performed using the CMAC D-Blade | Device | CMAC D-Blade Group |
| CMAC Video StyletIntubation will be performed using the CMAC Video stylet | Device | CMAC Video Style Group |
Primary outcome
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.
12 secondary outcomes
Duration of the successful intubation attempt
Time frame: At the time of the procedure
Number of intubation attempts
Time frame: At the time of the procedure
Intubation Difficulty Score (IDS)
Time frame: At the time of the procedure
Cormack-Lehane Classification and percentage of glottic view
Time frame: At the time of the procedure
Video classification of intubation (VCI)
Time frame: At the time of the procedure
Need for Alternative Intubation Devices
Time frame: At the time of the procedure
Stress response of intubation
Time frame: At the time of the procedure
Heart rate
Time frame: At the time of the procedure
Mean arterial blood pressure (MAP)
Time frame: At the time of the procedure
Complications
Time frame: At the time of the procedure
Operator satisfaction
Time frame: At the time of the procedure
Patient satisfaction
Time frame: At the time of the procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Individual participant dataSharing planned: 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
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?
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; AzTrials last refreshed its copy on 8 Nov 2026.