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

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

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.

Study Overview

• Status: Unknown
• Conditions: Single Lung Ventilation; Thoracic Anesthesia
• Intervention / Treatment: Device: C-MAC video-stylet; Device: Macintosh laryngoscope

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 Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt, 000000
    • rehab Abd Elaziz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: C-MAC-VS group; C-MAC-VS will be used to facilitate intubation	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.
PLACEBO_COMPARATOR: control group; direct laryngoscopy using Macintosh laryngoscope will be done for DLT insertion.	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the time taken for intubation (TTI) by C-MAC-VS	timing for intubation	5 minutes

Collaborators and Investigators

• Sponsor: Alexandria University

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 20, 2020
• Primary Completion (ANTICIPATED): May 20, 2021
• Study Completion (ANTICIPATED): June 1, 2021

Study Registration Dates

• First Submitted: February 13, 2021
• First Submitted That Met QC Criteria: February 13, 2021
• First Posted (ACTUAL): February 17, 2021

Study Record Updates

• Last Update Posted (ACTUAL): February 17, 2021
• Last Update Submitted That Met QC Criteria: February 13, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 0304793

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No