C-MAC Video-stylet for Double- Lumen Tracheal Intubation

Not Applicable

• Conditions: Thoracic Anesthesia; Single Lung Ventilation
• Interventions: Device: C-MAC video-stylet; Device: Macintosh laryngoscope

• Registration Number: NCT04757558
• Lead Sponsor: Alexandria University

Brief Summary

C-MAC Video Stylet secures the airway. It is a completely new type of video endoscope, it combines the advantages of both rigid and flexible intubation endoscopes. Video allows everyone involved in the intubation to visualize the anatomy simultaneously which facilitates communication and teamwork.

Detailed Description

It can be connected easily to the same C- MAC monitor and Pocket Monitor without requiring any additional light source and camera. Video allows everyone involved in the intubation to visualize the anatomy simultaneously which facilitates communication and teamwork. The device has no lumens so it's very easy to clean. Basically if you can get a tube between the cheek and teeth you can intubate the patient.

Study Timeline

• Study Start: 2020-12-20
• Status Verified: 2021-02
• Study First Submitted: 2021-02-13
• Study First Submitted QC: 2021-02-13
• Last Update Submitted: 2021-02-13
• Study First Posted: 2021-02-17
• Last Update Posted: 2021-02-17
• Primary Completion: 2021-05-20
• Study Completion: 2021-06-01

Recruitment & Eligibility

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

Inclusion Criteria

• aged 18-60 years,
• of both sex
• of American Society of Anesthesiologists (ASA) physical Status II and III
• undergoing elective intra-thoracic surgeries requiring double lumen intubation. BMI -< 35 kg/m2,
• with Mallampati score of 1 or 2

Exclusion Criteria

• 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
• r difficult mask ventilation; - severe pulmonary ventilation dysfunction
• risk of pulmonary aspiration.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
C-MAC-VS group	C-MAC video-stylet	C-MAC-VS will be used to facilitate intubation
control group	Macintosh laryngoscope	direct laryngoscopy using Macintosh laryngoscope will be done for DLT insertion.

Primary Outcome Measures

Name	Time	Method
the time taken for intubation (TTI) by C-MAC-VS	5 minutes	timing for intubation

Trial Locations

Locations (1)

rehab Abd Elaziz; 🇪🇬 Alexandria, Egypt