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

NCT ID: NCT03709979

Last Updated: 2019-02-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-21

Study Completion Date

2019-02-18

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Anesthesia Intubation Laryngoscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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C-MAC with folded towel position

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

Group Type ACTIVE_COMPARATOR

C-MAC videolaryngoscope

Intervention Type 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

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

Group Type PLACEBO_COMPARATOR

C-MAC videolaryngoscope

Intervention Type DEVICE

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

Interventions

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C-MAC videolaryngoscope

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

Intervention Type DEVICE

Eligibility Criteria

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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
Maximum Eligible Age

24 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Inonu University

OTHER

Sponsor Role lead

Responsible Party

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Zekine Begec

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zekine Begec, Professor

Role: PRINCIPAL_INVESTIGATOR

Inonu University Medical Faculty

Locations

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Turgut Ozal Medical Center

Malatya, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type RESULT
PMID: 26986776 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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C-Mac

Identifier Type: -

Identifier Source: org_study_id

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