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

Single Lung Ventilation Clinical Trial

Official title:

C-MAC Video-stylet for Double- Lumen Tracheal Intubation: a Prospective Randomized Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04757558
• Other study ID #: 0304793
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 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 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.

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.

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:

• 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.

Related Conditions & MeSH terms

• Single Lung Ventilation
• Thoracic Anesthesia

Intervention

Device:
• C-MAC video-stylet
Patients will be randomly assigned two group 40 patients each, C-MAC-VS group (VS group) (Karl Storz GmbHand Co.KG, Germany), and control group (C group). This will be done using a closed envelope technique using a computer-generated block randomization method.
• Macintosh laryngoscope
Patients will be randomly assigned two group 40 patients each, C-MAC-VS group (VS group) (Karl Storz GmbHand Co.KG, Germany), and control group (C group). This will be done using a closed envelope technique using a computer-generated block randomization method.

Locations

Country	Name	City	State
Egypt	rehab Abd Elaziz	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the time taken for intubation (TTI) by C-MAC-VS	timing for intubation	5 minutes