The Effect of Different Videolaryngoscopes on Intubation... | NCT03402581

Studies
The Effect of Different Videolaryngoscopes on Intubation Success in Obese Patients

NCT03402581

Sponsor

Ankara University

Status

Completed

Last Update Posted

Mar 2, 2020Actual

Enrollment

100Actual

Phase

Not provided

Conditions

Difficult Airway, Videolaryngoscopes

Interventions

c-mac laryngoscope

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

Feb 2020

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

Sep 2, 2018Actual

Primary Completion Date

Dec 1, 2018Actual

Completion Date

Dec 1, 2018Actual

First Submitted Date

Jan 11, 2018

First Submission Date that Met QC Criteria

Jan 11, 2018

First Posted Date

Jan 18, 2018Actual

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

Feb 28, 2020

Last Update Posted Date

Mar 2, 2020Actual

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

Obese patients may have difficulty in airway management.Patients who have body mass index > 35 are challenging patients for anesthesiologist. Short neck, more adipose tissue may be reasons for airway difficulty. Videolaryngoscopes are devices that ease the management of difficult airway.This study is designed to evaluate the differences and the effects of different laryngoscopes.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Year

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
c-mac used for intubation		obese patients intubated with c-mac videolaryngoscope	Device: c-mac laryngoscope
mc-grath used for intubation		obese patients intubated with mc-grath videolaryngoscope	Device: c-mac laryngoscope

Interventions

Name	Type	Description	Arm Group Labels	Other Names
c-mac laryngoscope	Device	type of laryngoscopes	c-mac used for intubation mc-grath used for intubation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
intubation difficulty	the management of airway	1 minute

Secondary Outcomes

Measure	Description	Time Frame
airway assesment	evaluating the airway	1 minute

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

body mass index> 35

Exclusion Criteria:

emergency airway

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

patients undergoing elective surgery and have body mass index > 35

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
CIGDEM YILDIRIMGUCLU	Ankara University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ankara University		Ankara		06550	Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided