Comparison of Two Blades of Videolaryngoscope in Simulated Difficult Airway in Children

Comparison of Two Blades of Videolaryngoscope in Simulated Difficult Airway in Children, a Randomized Controlled Trial

Airway management and tracheal intubation are routinely performed in paediatric anaesthesia and yet are associated with preventable adverse events. The D-blade of videolaryngoscope is preferred in difficult intubation with a more curved blade then the Macintosh videolaryngoscope blade, which may be more useful in difficult intubation. The aim of the study is to compare the D-blade of videolaryngoscope with Macintosh videolaryngoscope blade.

Study Overview

• Status: Completed
• Conditions: Intubation;Difficult
• Intervention / Treatment: Device: D-blade of videolaryngoscope; Other: simulated difficult airway; Device: Macintosh videolaryngoscope

• Study Type: Interventional
• Enrollment (Actual): 47
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Kocaeli, Turkey, 41000
    • Kocaeli University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 5 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• ASA I-II patients
• Undergoing elective surgeries
• Age between 1-5 years

Exclusion Criteria:

• Anticipated difficult intubation
• Pulmonery diseases
• >III ASA scores

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: D-blade group; Intubation will be done using D-blade of videolaryngoscope in a simulated difficult airway Difficult airway will be simulated with collar.	Device: D-blade of videolaryngoscope; intubation will be done using d-blade of videolaryngoscope; Other: simulated difficult airway; extension of head will be limited by using collar.
ACTIVE_COMPARATOR: Macintosh group; Intubation will be done using Macintosh videolaryngoscope in a simulated difficult airway Difficult airway will be simulated with collar.	Other: simulated difficult airway; extension of head will be limited by using collar.; Device: Macintosh videolaryngoscope; intubation will be done using macintosh videolaryngoscope

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
intubation time	Time of endotracheal intubation will be recorded.	time between handling videolaryngoscope and inserting endotracheal tube

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cormack and Lehane score	Cormack and Lehane scores from 1 to 4 where 1 is the best and 4 is the worst score for laryngoscopy view will be recorded for each patient	During the intubation

Collaborators and Investigators

• Sponsor: Kocaeli University
• Investigators: Principal Investigator: Alparslan Kus, MD, Kocaeli University School of Medicine

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 15, 2018
• Primary Completion (ACTUAL): February 15, 2019
• Study Completion (ACTUAL): March 15, 2019

Study Registration Dates

• First Submitted: October 20, 2018
• First Submitted That Met QC Criteria: October 23, 2018
• First Posted (ACTUAL): October 25, 2018

Study Record Updates

• Last Update Posted (ACTUAL): November 10, 2020
• Last Update Submitted That Met QC Criteria: November 8, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: D-Blade; Macintosh videolaryngoscope blade; Simulated difficult intubation
• Other Study ID Numbers: 2018-154

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No