Effect Of Position On Laryngeal Visualisation With The C-Mac Videolaryngoscope

NCT03709979 | Completed

• 1 other identifier: C-Mac
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anesthesia; Intubation; Laryngoscopy

Keywords

video laryngoscopy; Pediatric patient; Position

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Time to intubation

  From beginning of holding videolaryngoscope to seeing two meaningful end-tidal carbon dioxide levels up to 3 minutes

Study Arms (2)

C-MAC with folded towel position

ACTIVE COMPARATOR

Children will be intubated by C-MAC videolaryngoscope with placing a folded towel under the shoulder.

Device: C-MAC videolaryngoscope

C-MAC with flat position

PLACEBO COMPARATOR

Children will be intubated by C-MAC videolaryngoscope with flat position (non-inserted a folded towel)

Device: C-MAC videolaryngoscope

Interventions

C-MAC videolaryngoscope DEVICE

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

C-MAC with flat position; C-MAC with folded towel position

Eligibility Criteria

• Age: Up to 24 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• upper respiratory tract infection within the previous 4 weeks
• airway difficulties in the preoperative evaluation
• unstable reactions during intubation

Sponsors & Collaborators

• Inonu University: lead

Study Sites (1)

Turgut Ozal Medical Center

Malatya, 44315, Turkey (Türkiye)

Location

Related 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.0000000000000448.

  PMID: 26986776 RESULT

Study Officials

• Zekine Begec, Professor

  Inonu University Medical Faculty

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 11, 2018
• First Posted: October 17, 2018
• Study Start: January 21, 2019
• Primary Completion: February 18, 2019
• Study Completion: February 18, 2019
• Last Updated: February 19, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)