Effectiveness of C-MAC Video-stylet Versus C-MAC D- Blade Video-laryngoscope for Tracheal Intubation

Effectiveness of C-MAC Video-stylet Versus C-MAC D- Blade Video-laryngoscope for Tracheal Intubation in Patients With Predicted Difficult Airway: Randomized Comparative Study

Videolaryngoscopy provides a better laryngeal view and do not need airway alignment for tracheal intubation.

Study Overview

• Status: Active, not recruiting
• Conditions: Difficult Intubation; Difficult Mask Ventilation
• Intervention / Treatment: Device: C-MAC VS; Device: C-MAC VL D -blade

Detailed Description

The C-MAC-VS can be connected easily to the same C- MAC monitor and Pocket Monitor without requiring any additional light source and camera. This device is great for cases with limited mouth opening, airway obstruction and difficult intubation. C-MAC-VS has no lumens so it's very easy to clean and it can accommodates a size ETT 6.0 and greater.

• Study Type: Interventional
• Enrollment (Anticipated): 160
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt, 000000
    • rehab Abd Elaziz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• patients with BMI ≥ 30 kg/m2,
• presence of any predictors of difficult intubation;
• Mallampati score > =3;
• inter-incisor distance < 3 cm;
• thyromental distance < 6 cm;
• neck extension < 80°from neck flexion;
• cervical spine instability; history of difficult endotracheal intubation or difficult mask ventilation

Exclusion Criteria:

• patients have increased risk of pulmonary aspiration;
• have significant medical diseases in term of cardiac, respiratory, hepatic, renal

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Group C-MAC VS; patients undergoing tracheal intubation using the C-MAC VS.	Device: C-MAC VS; patients undergoing tracheal intubation using the C-MAC VS
PLACEBO_COMPARATOR: Group C-MAC VL D -blade; patients undergoing intubation using the C-MAC VL D-blade.	Device: C-MAC VL D -blade; patients undergoing intubation using the C-MAC VL D-blade.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
duration of intubation procedure	assess duration of intubation procedure by using C-MAC VS versus C-MAC D-blade in patients with anticipated difficult airway.	10 minutes

Collaborators and Investigators

• Sponsor: Alexandria University

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 10, 2022
• Primary Completion (ANTICIPATED): May 1, 2022
• Study Completion (ANTICIPATED): July 1, 2022

Study Registration Dates

• First Submitted: February 15, 2021
• First Submitted That Met QC Criteria: February 15, 2021
• First Posted (ACTUAL): February 18, 2021

Study Record Updates

• Last Update Posted (ACTUAL): June 1, 2022
• Last Update Submitted That Met QC Criteria: May 29, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 0304844

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No