NCT03719638

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 20, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 25, 2018

Completed
21 days until next milestone

Study Start

First participant enrolled

November 15, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2019

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2019

Completed
Last Updated

November 10, 2020

Status Verified

November 1, 2020

Enrollment Period

3 months

First QC Date

October 20, 2018

Last Update Submit

November 8, 2020

Conditions

Intubation;Difficult

Keywords

D-BladeMacintosh videolaryngoscope bladeSimulated difficult intubation

Outcome Measures

Primary Outcomes (1)

  • intubation time

    Time of endotracheal intubation will be recorded.

    time between handling videolaryngoscope and inserting endotracheal tube

Secondary Outcomes (1)

  • Cormack and Lehane score

    During the intubation

Study Arms (2)

D-blade group

ACTIVE COMPARATOR

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 videolaryngoscopeOther: simulated difficult airway

Macintosh group

ACTIVE COMPARATOR

Intubation will be done using Macintosh videolaryngoscope in a simulated difficult airway Difficult airway will be simulated with collar.

Other: simulated difficult airwayDevice: Macintosh videolaryngoscope

Interventions

D-blade of videolaryngoscopeDEVICE

intubation will be done using d-blade of videolaryngoscope

D-blade group
simulated difficult airwayOTHER

extension of head will be limited by using collar.

D-blade groupMacintosh group
Macintosh videolaryngoscopeDEVICE

intubation will be done using macintosh videolaryngoscope

Macintosh group

Eligibility Criteria

Age1 Year - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kocaeli University

Kocaeli, 41000, Turkey (Türkiye)

Location

Study Officials

  • Alparslan Kus, MD

    Kocaeli University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 20, 2018

First Posted

October 25, 2018

Study Start

November 15, 2018

Primary Completion

February 15, 2019

Study Completion

March 15, 2019

Last Updated

November 10, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)