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

Not Applicable

• Conditions: Difficult Mask Ventilation; Difficult Intubation
• Interventions: Device: C-MAC VS; Device: flexible fibreoptic bronchoscope

• Registration Number: NCT04759287
• Lead Sponsor: rehab zayed

Brief Summary

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

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 Timeline

• Study Start: 2020-11-20
• Status Verified: 2021-02
• Study First Submitted: 2021-02-15
• Study First Submitted QC: 2021-02-15
• Last Update Submitted: 2021-02-15
• Study First Posted: 2021-02-18
• Last Update Posted: 2021-02-18
• Primary Completion: 2021-05-20
• Study Completion: 2021-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VS group	C-MAC VS	include patients undergoing awake intubation using the C-MAC VS
FOB group	flexible fibreoptic bronchoscope	will include patients undergoing awake intubation using the flexible fibreoptic bronchoscope.

Primary Outcome Measures

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

Trial Locations

Locations (1)

rehab Abd Elaziz; 🇪🇬 Alexandria, Egypt