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

• Sponsor: Inonu University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03709979
• Collaborator: (none)
• Enrollment: 96
• Location: 1
• Arms: 2
• Actual Duration (Days): 28
• Patients Per Site Per Month: 104.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anesthesia; Intubation; Laryngoscopy	Device: C-MAC videolaryngoscope	N/A

Detailed 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 96 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Other
• Official Title: Inönü University Department of Anesthesia
• Actual Study Start Date: Jan 21, 2019
• Actual Primary Completion Date: Feb 18, 2019
• Actual Study Completion Date: Feb 18, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: C-MAC with folded towel position Children will be intubated by C-MAC videolaryngoscope with placing a folded towel under the shoulder.	Device: C-MAC videolaryngoscope; An intubating device that is used for endotracheal intubation. Endotracheal intubation will be performed by anesthesiologist with C-MAC videolaryngoscope
Placebo Comparator: C-MAC with flat position Children will be intubated by C-MAC videolaryngoscope with flat position (non-inserted a folded towel)	Device: C-MAC videolaryngoscope; An intubating device that is used for endotracheal intubation. Endotracheal intubation will be performed by anesthesiologist with C-MAC videolaryngoscope

Outcome Measures

Primary Outcome Measures

1. Percentage of glottic opening score [immediately before endotracheal intubation]

   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%

Secondary Outcome Measures

1. Time to intubation [From beginning of holding videolaryngoscope to seeing two meaningful end-tidal carbon dioxide levels up to 3 minutes]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 24 Months
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Turgut Ozal Medical Center	Malatya		Turkey	44315

Sponsors and Collaborators

• Inonu University

Investigators

• Principal Investigator: Zekine Begec, Professor, Inonu University Medical Faculty

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Dec 21, 2016

More Information

Publications

None provided.

• Responsible Party: Zekine Begec, Professor, Inonu University
• ClinicalTrials.gov Identifier: NCT03709979
• Other Study ID Numbers: C-Mac
• First Posted: Oct 17, 2018
• Last Update Posted: Feb 19, 2019
• Last Verified: Feb 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Zekine Begec, Professor, Inonu University: video laryngoscopy; Pediatric patient; Position

Study Results

No Results Posted as of Feb 19, 2019