Insertion of Different Supraglottic Airway Devices on Man... | NCT05523752

Studies
Insertion of Different Supraglottic Airway Devices on Manikin

NCT05523752

Sponsor

Zonguldak Bulent Ecevit University

Status

Completed

Last Update Posted

Aug 31, 2022Actual

Enrollment

1Actual

Phase

Not Applicable

Conditions

Ventilation
Airway Management
Education

Interventions

Proseal Laryngeal Mask
Classic Laryngeal Mask
I-gel
Suprema Laryngeal Mask

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

Aug 2022

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

Mar 1, 2022Actual

Primary Completion Date

Jul 30, 2022Actual

Completion Date

Aug 15, 2022Actual

First Submitted Date

Aug 16, 2022

First Submission Date that Met QC Criteria

Aug 29, 2022

First Posted Date

Aug 31, 2022Actual

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

Aug 29, 2022

Last Update Posted Date

Aug 31, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Keziban Bollucuoglu, anesthesiologist, 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

When tracheal intubation and face mask ventilation fail, and the insertion of supraglottic airway devices (SHA) can provide ventilation, protecting the patient from hypoxemia. Supraglottic airway devices have become an important part of difficult airway algorithms. The European Resuscitation Council Guidelines recommend supraglottic airway devices for airway management by non-specialized healthcare providers. Education through simulators contributes to the development of students without direct contact with patients. In this study, it was aimed to compare the success of placement of four different supraglottic airway devices on the manikin of term 5 students who participate to the Anesthesiology and Reanimation internship.

Detailed Description

Not provided

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

1Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Proseal Laryngeal Mask	Other	Device: Proseal Laryngeal Mask
Classic Laryngeal Mask	Other	Device: Classic Laryngeal Mask
I-gel	Other	Device: I-gel
Suprema Laryngeal Mask	Other	Device: Suprema Laryngeal Mask

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Proseal Laryngeal Mask	Device	insertion of Proseal Laryngeal Mask	Proseal Laryngeal Mask

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
difficulty of attempts	pointing the difficulty of insertion from 0 to 100	during insertion procedure

Secondary Outcomes

Measure	Description	Time Frame
Time of attempts	time from insertion to ventilation	during insertion procedure
number of attempts	number of attempts for successfull placement

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Studying in medical school in term 5
To have completed anesthesiology and reanimation internship

Exclusion Criteria:

who do not want to participate in the study
Students with previous experience with four airway devices

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

30 Years

Standard Ages

Adult

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
Zonguldak Bülent Ecevit University		Zonguldak	Kozlu	67600	Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D053120	Respiratory Aspiration

Ancestor Terms

ID	Term
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided