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

NCT06981923 | Completed

• 1 other identifier: CMAC D-Blade or Video Stylet
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 2

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.

Conditions

Difficult Intubation in Obesity

Keywords

CMAC D-Blade; CMAC Video-style; bariatric patients; Simplified Airway Risk Index (SARI)

Outcome Measures

Primary Outcomes (1)

• First-Pass Success Rate

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

  At the time of the procedure

Secondary Outcomes (7)

• Time to Intubation

  At the time of the procedure

• Intubation Difficulty Score (IDS)

  At the time of the procedure

• Stress response of intubation

  At the time of the procedure

• awake Cormack-Lehane Classification

  At the time of the procedure

• Operator satisfaction

  At the time of the procedure

Study Arms (2)

CMAC D-Blade Group

ACTIVE COMPARATOR

Intubation will be performed using the CMAC D-Blade

Device: CMAC D-Blade

CMAC Video Style Group

ACTIVE COMPARATOR

Intubation will be performed using the CMAC Video stylet

Device: CMAC Video Stylet

Interventions

CMAC D-Blade DEVICE

Intubation will be performed using the CMAC D-Blade

CMAC D-Blade Group

CMAC Video Stylet DEVICE

Intubation will be performed using the CMAC Video stylet

CMAC Video Style Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• General Committee of Teaching Hospitals and Institutes, Egypt: lead

Study Sites (2)

Madina Women's Hospital

Alexandria, 21531, Egypt

Location

The surgical department of Medical Research Institute Hospital, Alexandria University

Alexandria, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of General surgery, Surgeon

Model Details: 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.

Study Record Dates

• First Submitted: May 11, 2025
• First Posted: May 21, 2025
• Study Start: May 10, 2025
• Primary Completion: September 10, 2025
• Study Completion: September 22, 2025
• Last Updated: October 7, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Whole study period
• Access Criteria: Ask contact person

Locations

EG (2)