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

• ClinicalTrials.gov Identifier: NCT03719638
• Recruitment Status: Completed
• First Posted: October 25, 2018
• Last Update Posted: November 10, 2020
• Sponsor: Kocaeli University
• Information provided by (Responsible Party): Alparslan Kus, Kocaeli University

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Intubation;Difficult	Device: D-blade of videolaryngoscope; Other: simulated difficult airway; Device: Macintosh videolaryngoscope	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 47 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Other
• Official Title: Comparison of Two Blades of Videolaryngoscope in Simulated Difficult Airway in Children, a Randomized Controlled Trial
• Actual Study Start Date: November 15, 2018
• Actual Primary Completion Date: February 15, 2019
• Actual Study Completion Date: March 15, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. intubation time [ Time Frame: time between handling videolaryngoscope and inserting endotracheal tube ]
   Time of endotracheal intubation will be recorded.

Secondary Outcome Measures :

1. Cormack and Lehane score [ Time Frame: During the intubation ]
   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

Eligibility Criteria

• Ages Eligible for Study: 1 Year to 5 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

Turkey

Kocaeli University

Kocaeli, Turkey, 41000

Sponsors and Collaborators

Kocaeli University

Investigators

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

More Information

• Responsible Party: Alparslan Kus, Associate Professor, Kocaeli University
• ClinicalTrials.gov Identifier: NCT03719638
• Other Study ID Numbers: 2018-154
• First Posted: October 25, 2018
• Last Update Posted: November 10, 2020
• Last Verified: November 2020

Individual Participant Data (IPD) Sharing Statement:

• 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 Alparslan Kus, Kocaeli University:

D-Blade; Macintosh videolaryngoscope blade; Simulated difficult intubation