NCT02069444

Brief Summary

For endotracheal entubation in children mostly Miller and Macintosh blades have been used. On the other hand Truview EVO2 laringoscopes can maintain a better laryngeal view without having a direct sight of the airway and without having to align oral, pharyngeal, and tracheal axes. The aim of this study is to compare the Truview EVO2 laryngoscope and Macintosh laryngoscope in terms of intubation difficulty score, time to intubation and intubation quality score.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Geographic Reach
1 country

2 active sites

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

Study Start

First participant enrolled

January 1, 2012

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

February 20, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 24, 2014

Completed
Last Updated

February 24, 2014

Status Verified

February 1, 2014

Enrollment Period

9 months

First QC Date

February 20, 2014

Last Update Submit

February 21, 2014

Conditions

All the Pediatric Patients Needed Intubation for Surgery

Outcome Measures

Primary Outcomes (1)

  • ease laryngoscopy in children

    during laryngoscopy

Study Arms (2)

Truview EVO2 laryngoscope

patients intubated withTruview EVO2 laryngoscope

Procedure: Truview EVO2 laryngoscope

Macintosh laryngoscope

patients intubated with Macintosh laryngoscope

Procedure: Macintosh laryngoscope

Interventions

Macintosh laryngoscopePROCEDURE

intubation criterias withMacintosh laryngoscopein pediatric patients

Macintosh laryngoscope
Truview EVO2 laryngoscopePROCEDURE

intubation criterias with Truview EVO2 laryngoscope in pediatric patients

Truview EVO2 laryngoscope

Eligibility Criteria

Age2 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

pediatric patients undergoing surgery which needs intubation

You may qualify if:

  • aged 2-12 pediatric patients

You may not qualify if:

  • any allergy
  • difficult airway history

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ankara University

Ankara, 06550, Turkey (Türkiye)

Location

Ankara University, Pediatric Surgery

Ankara, Turkey (Türkiye)

Location

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
specialist anesthesiologist

Study Record Dates

First Submitted

February 20, 2014

First Posted

February 24, 2014

Study Start

January 1, 2012

Primary Completion

October 1, 2012

Last Updated

February 24, 2014

Record last verified: 2014-02

Locations

TU(2)