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NCT04759287 Clinical Trial

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

Difficult Intubation Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04759287
Other study ID # 0304792
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date November 20, 2020
Est. completion date June 1, 2021

Study information
Verified date February 2021
Source Alexandria University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 80
Est. completion date June 1, 2021
Est. primary completion date May 20, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Device:
• C-MAC VS
The first group (VS group) will include patients undergoing awake intubation using the C-MAC VS
• flexible fibreoptic bronchoscope
The second control group (FOB group) will include patients undergoing awake intubation using the flexible fibreoptic bronchoscope.

Locations
Country Name City State
Egypt rehab Abd Elaziz Alexandria

Sponsors (1)
Lead Sponsor Collaborator
rehab zayed

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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