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
• Status: Active, not recruiting
• Phase: N/A
• 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
• 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,

Related Conditions & MeSH terms

• Difficult Intubation
• Difficult Mask Ventilation

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