CClinicalTrials.gg
Status unknownNCT04757558Updated Feb 17, 2021

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

An interventional study of C-MAC video-stylet and Macintosh laryngoscope in Single Lung Ventilation and Thoracic Anesthesia, sponsored by Alexandria University. Status unknown at 1 site in Egypt. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2021-02-17.

Sponsored by Alexandria University · Not applicable, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Feb 2021), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Single Lung Ventilation
  • Thoracic Anesthesia
03

In context

Lead sponsor

Alexandria University is the lead sponsor of 569 studies on the registry; 125 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
80 participants (estimated)

Study arms

  • Active comparator
    C-MAC-VS group

    C-MAC-VS will be used to facilitate intubation

    Device: C-MAC video-stylet

  • Placebo comparator
    control group

    direct laryngoscopy using Macintosh laryngoscope will be done for DLT insertion.

    Device: Macintosh laryngoscope

Interventions

  • DeviceC-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.

  • DeviceMacintosh 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.

06

What researchers measure

Primary outcomes

  1. the time taken for intubation (TTI) by C-MAC-VS

    timing for intubation

    Time frame: 5 minutes

07

Study locations

1 site
  • rehab Abd Elaziz
    Alexandria, 000000, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 17, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04757558
Lead sponsor
Alexandria University
Responsible party
rehab zayed (Assisstant Professor of Anesthesia, Alexandria University) — Principal investigator
First posted
Feb 17, 2021
Start date
Dec 20, 2020
Primary completion
May 20, 2021 (estimated)
Completion
Jun 1, 2021 (estimated)
Last update
Feb 17, 2021

Study contacts

rehab A. Abd Elaziz, Ass.Prof.
principal investigator · Alexandria University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.

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