Comparison of Different Video Laryngoscopes in < 1 Year O... | NCT04153357

Studies
Comparison of Different Video Laryngoscopes in < 1 Year Old Undergoing Neurosurgical Operations: a Prospective Randomized Study

NCT04153357

Sponsor

Kocaeli University

Status

Completed

Last Update Posted

Mar 21, 2023Actual

Enrollment

50Actual

Phase

Not Applicable

Conditions

Intubation;Difficult

Interventions

airtraq
c-mac

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 5, 2019Actual

Primary Completion Date

Feb 5, 2020Actual

Completion Date

Feb 5, 2020Actual

First Submitted Date

Nov 4, 2019

First Submission Date that Met QC Criteria

Nov 4, 2019

First Posted Date

Nov 6, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 17, 2023

Last Update Posted Date

Mar 21, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

İntubation of pediatric patients is a challenging problem. Video laryngoscopes increased the intubation success rate. We want to compare different video laryngoscopes in this field.

Detailed Description

Aim:İntubation of pediatric patients is a challenging problem. Video laryngoscopes increased the intubation success rate. We want to compare different video laryngoscopes in this field.

methods: We enroll total 50 patients < 1 year old undergoing neurosurgery. We compared the intubation times, success rates and minor complications of Airtraq and c-mac video laryngoscopes in these pediatric patients undergoing neurosurgery.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
intubation time airtraq	Active Comparator	intubation time of Airtraq	Device: airtraq
intubation time of c-mac	Active Comparator	intubation time of c-mac	Device: c-mac

Interventions

Name	Type	Description	Arm Group Labels	Other Names
airtraq	Device	device entering the oral cavity till visualization of the endotracheal tube entering the vocal cords	intubation time airtraq

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
intubation time	device entering the oral cavity till visualization of the endotracheal tube entering the vocal cords	30 seconds

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

< 1 years old

undergoing neurosurgery ASA 1-2

Exclusion Criteria:

> 1 year old
asa 3-4
emergency

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Month

Maximum Age

1 Year

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kocaeli University Medical Faculty		Kocaeli			Turkey (Türkiye)