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

Sponsor
Alexandria University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04757558
Collaborator
(none)
80
Enrollment
1
Location
2
Arms
5.4
Anticipated Duration (Months)
14.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: C-MAC video-stylet
  • Device: Macintosh laryngoscope
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Diagnostic
Official Title:
C-MAC Video-stylet for Double- Lumen Tracheal Intubation: a Prospective Randomized Study
Actual Study Start Date :
Dec 20, 2020
Anticipated Primary Completion Date :
May 20, 2021
Anticipated Study Completion Date :
Jun 1, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. the time taken for intubation (TTI) by C-MAC-VS [5 minutes]

    timing for intubation

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
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:

  • 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 rehab Abd Elaziz Alexandria Egypt 000000

Sponsors and Collaborators

  • Alexandria University

Investigators

  • Principal Investigator: rehab A. Abd Elaziz, Ass.Prof., Alexandria University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
rehab zayed, Assisstant Professor of Anesthesia, Alexandria University
ClinicalTrials.gov Identifier:
NCT04757558
Other Study ID Numbers:
  • 0304793
First Posted:
Feb 17, 2021
Last Update Posted:
Feb 17, 2021
Last Verified:
Feb 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Feb 17, 2021