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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03709979
Other study ID # C-Mac
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 21, 2019
Est. completion date February 18, 2019

Study information

Verified date February 2019
Source Inonu University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this study is to demonstrate the effect of C-Mac videolaryngoscopy with Miller Blade size 0 and 1 on the intubation conditions in children less than 2 years age with a roll inserted under the shoulders.


Description:

The laryngoscopic view of the glottis is improved when the angle of the line of vision between the pharyngeal - laryngeal axis and the oral cavity axis is narrow. A roll inserted under the shoulders of the infant will help line up the oral, laryngeal, and pharyngeal axes making direct laryngoscopy easier.

The investigators hypothesized that laryngoscopic view and intubation conditions using C-Mac videolaryngoscope with Miller Blade size 0 and 1 would be better with a roll under shoulder in children under 2 years.


Recruitment information / eligibility

Status Completed
Enrollment 96
Est. completion date February 18, 2019
Est. primary completion date February 18, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 24 Months
Eligibility Inclusion Criteria:

- less than 2 years age undergoing general anaesthesia with tracheal intubation for elective surgery

- American Society of Anesthesiologists' physical status either 1 or 2 are included

Exclusion Criteria:

- upper respiratory tract infection within the previous 4 weeks

- airway difficulties in the preoperative evaluation

- unstable reactions during intubation

Study Design


Related Conditions & MeSH terms


Intervention

Device:
C-MAC videolaryngoscope
An intubating device that is used for endotracheal intubation. Endotracheal intubation will be performed by anesthesiologist with C-MAC videolaryngoscope

Locations

Country Name City State
Turkey Turgut Ozal Medical Center Malatya

Sponsors (1)

Lead Sponsor Collaborator
Inonu University

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

Kim EH, Lee JH, Song IK, Kim JT, Kim BR, Kim HS. Effect of head position on laryngeal visualisation with the McGrath MAC videolaryngoscope in paediatric patients: A randomised controlled trial. Eur J Anaesthesiol. 2016 Jul;33(7):528-34. doi: 10.1097/EJA.0 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of glottic opening score Percentage of glottic opening score of 100% denotes visualization of the entire glottis, from the anterior commissure of the vocal cords to the inter-arytenoid notch. If no part of the glottic opening was visualized, the POGO score was recorded as 0% immediately before endotracheal intubation
Secondary Time to intubation Time to intubation will be measured from the time the videolaryngoscope entered the patient's mouth until the first capnograph trace is seen on the monitor From beginning of holding videolaryngoscope to seeing two meaningful end-tidal carbon dioxide levels up to 3 minutes
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