Effectiveness of C-MAC Video-stylet Versus Fiberoptic Bronchoscope for Awake Intubation

Effectiveness of C-MAC Video-stylet Versus Fiberoptic Bronchoscope for Awake Intubation in Patients With Predicted Difficult Airway

C-MAC- Video Stylet is a completely new type of video endoscope. It combines the advantages of both rigid and flexible intubation endoscopes.

Study Overview

• Status: Active, not recruiting
• Conditions: Difficult Intubation; Difficult Mask Ventilation
• Intervention / Treatment: Device: C-MAC VS; Device: flexible fibreoptic bronchoscope

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 80
• 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 Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: VS group; include patients undergoing awake intubation using the C-MAC VS	Device: C-MAC VS; The first group (VS group) will include patients undergoing awake intubation using the C-MAC VS
Placebo Comparator: FOB group; will include patients undergoing awake intubation using the flexible fibreoptic bronchoscope.	Device: flexible fibreoptic bronchoscope; The second control group (FOB group) will include patients undergoing awake intubation using the flexible fibreoptic bronchoscope.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the time required for a wake intubation	assess the time required for a wake intubation using C-MAC VS versus FOB in patients with anticipated difficult airway.	10 minutes

Collaborators and Investigators

• Sponsor: rehab zayed

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2020
• Primary Completion (Anticipated): May 20, 2021
• Study Completion (Anticipated): June 1, 2021

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): February 18, 2021
• Last Update Submitted That Met QC Criteria: February 15, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 0304792

Drug and device information, study documents

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