NCT05523752

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

March 1, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2022

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2022

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

August 16, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 31, 2022

Completed
Last Updated

August 31, 2022

Status Verified

August 1, 2022

Enrollment Period

5 months

First QC Date

August 16, 2022

Last Update Submit

August 29, 2022

Conditions

VentilationAirway ManagementEducation

Keywords

Airway managementSupraglottic airway devicesManikin studyeducation

Outcome Measures

Primary Outcomes (1)

  • difficulty of attempts

    pointing the difficulty of insertion from 0 to 100

    during insertion procedure

Secondary Outcomes (2)

  • Time of attempts

    during insertion procedure

  • number of attempts

    during insertion procedure

Study Arms (4)

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

Classic Laryngeal MaskDEVICE

insertion of Classic Laryngeal Mask

Classic Laryngeal Mask
I-gelDEVICE

insertion of I-gel

I-gel
Suprema Laryngeal MaskDEVICE

insertion of Suprema Laryngeal Mask

Suprema Laryngeal Mask
Proseal Laryngeal MaskDEVICE

insertion of Proseal Laryngeal Mask

Proseal Laryngeal Mask

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zonguldak Bülent Ecevit University

Zonguldak, Kozlu, 67600, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
anesthesiologist

Study Record Dates

First Submitted

August 16, 2022

First Posted

August 31, 2022

Study Start

March 1, 2022

Primary Completion

July 30, 2022

Study Completion

August 15, 2022

Last Updated

August 31, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will share

Locations

TU(1)