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

A

Alexandria University

Status

Unknown

Conditions

Single Lung Ventilation
Thoracic Anesthesia

Treatments

Device: Macintosh laryngoscope
Device: C-MAC video-stylet

Study type

Interventional

Funder types

Other

Identifiers

NCT04757558
0304793

Details and patient eligibility

About

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.

Full 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.

Enrollment

80 estimated patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

80 participants in 2 patient groups, including a placebo group

C-MAC-VS group
Active Comparator group
Description:
C-MAC-VS will be used to facilitate intubation
Treatment:
Device: C-MAC video-stylet
control group
Placebo Comparator group
Description:
direct laryngoscopy using Macintosh laryngoscope will be done for DLT insertion.
Treatment:
Device: Macintosh laryngoscope

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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