Glottis Visualization in Different Lifting Methods | NCT05967338

Studies
Glottis Visualization in Different Lifting Methods

NCT05967338

Sponsor

Zonguldak Bulent Ecevit University

Status

Completed

Last Update Posted

Aug 1, 2023Actual

Enrollment

1Actual

Phase

Not provided

Conditions

Intubation
Glottis Visualization

Interventions

using McGrath Video 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

Jul 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

Jul 1, 2022Actual

Primary Completion Date

Jan 30, 2023Actual

Completion Date

Mar 1, 2023Actual

First Submitted Date

Jun 1, 2023

First Submission Date that Met QC Criteria

Jul 28, 2023

First Posted Date

Aug 1, 2023Actual

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

Jul 28, 2023

Last Update Posted Date

Aug 1, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Keziban Bollucuoglu, Principal Investigator, Zonguldak Bulent Ecevit UniversityPrincipal Investigator

Lead Sponsor

Zonguldak Bulent Ecevit UniversityOTHER

Collaborators

Not provided

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

Among the various types of video laryngoscopes, the McGrath MAC video laryngoscopy (VL) has become popular because it is lightweight and can be quickly and hygienically prepared by changing the blade. The aim of this study was to compare the efficacy of two different methods (direct and indirect) for epiglottis removal during visualization of the glottis using the McGrath MAC VL.

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

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group Direct		glottis visualization in direct lifting	Device: using McGrath Video Laryngoscope
Group Indirect		glottis visualization in indirect lifting	Device: using McGrath Video Laryngoscope

Interventions

Name	Type	Description	Arm Group Labels	Other Names
using McGrath Video Laryngoscope	Device	glottis visualization in indirect and direct lifting methods by using McGrath Video Laryngoscope	Group Direct Group Indirect

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
POGO scores	percentage of glottic opening	1 day (through intubation )

Secondary Outcomes

Measure	Description	Time Frame
Cormack-Lehane classification	assessment of laryngeal view during laryngoscopy	1 day (through intubation )

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

ASA I-II
general anesthesia in elective surgeries
18-65 years old
body mass index (25-30)
no risk of difficult intubation

Exclusion Criteria:

Allergic to study drugs
pregnant women
emergency cases
those with a history of difficult intubation
those without consent
those at risk of aspiration

Accepts Healthy Volunteers

Yes

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

ASA I-II, 18-65 years old patients undergoing elective surgery

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Zonguldak Bülent Ecevit University		Zonguldak	Kozlu	67600	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