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Endotracheal Intubation Using Three Laryngoscopes in Maternal Cardiac Arrest: a Manikin Simulation Study

Primary Purpose

Cardiac Arrest

Status

Completed

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

15 degree left-lateral tilt wedges

30 degree left-lateral tilt wedges

About this trial

This is an interventional basic science trial for Cardiac Arrest focused on measuring Endotracheal intubation, Left lateral tilt wedge, Maternal Cardiopulmonary Resuscitation, Manikin Study

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Experience of intubation > 50 times
Postgraduates year 1,2,3,4 and Emergency physicians in emergency department

Exclusion Criteria:

Wrist or Low back disease

Sites / Locations

Hanyang University Seoul Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Direct laryngoscope

Videolaryngoscope-1

Videolaryngoscope-2

Arm Description

Macintosh laryngoscope

Glidescope

Airwayscope

Outcomes

Primary Outcome Measures

Time to intubation

We will check the times from inserting blade to mouth to exposing vocal cord and from exposing vocal cord to first ambu-bagging.

Success rate of intubation

Definition of failed intubation Time to intubation is longer than 90 seconds. Wrong placement of endotracheal tube (For example : Esophageal intubation etc.)

Secondary Outcome Measures

Laryngeal View during intubation

We will record the best laryngeal View during intubation. We will record according to the Cormack-Lehane Grade system.

The preference for laryngoscopes

The preference for laryngoscope regardless of tilting degree of wedges The preference for laryngoscope in 15 degree left-lateral tilt situation . The preference for laryngoscope in 30 degree left-lateral tilt situation . (Participants will select only 1 of 3 laryngoscopes and the preference will be displayed as histogram)

Full Information

NCT ID

NCT02074072

First Posted

February 25, 2014

Last Updated

March 20, 2014

Sponsor

Hanyang University Seoul Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02074072

Brief Title

Endotracheal Intubation Using Three Laryngoscopes in Maternal Cardiac Arrest: a Manikin Simulation Study

Official Title

Comparison of Glidescope, Pentax-AWS and Macintosh Laryngoscope for Intubation During Chest Compression in 15-30 Degree Left-Lateral Tilt: A Manikin Simulation Study of Maternal Cardiopulmonary Resuscitation

Study Type

Interventional

2. Study Status

Record Verification Date

March 2014

Overall Recruitment Status

Completed

Study Start Date

March 2014 (undefined)

Primary Completion Date

March 2014 (Actual)

Study Completion Date

March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hanyang University Seoul Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

European Resuscitation Council (ERC) Guidelines for Resuscitation 2010 emphasize high quality chest compressions .They propose minor changes for pregnant women: manual left deviation of the uterus or a left-lateral incline of 15-30to alleviate pressure on the inferior vena cava. We will examine the performance of the Glidescope (GVL), the Pentax-AWS Airwayscope(AWS) and Macintosh laryngoscope (McL) for airway management during chest compressions on 15 and 30 degree left-lateral tilt (15 &30 LLT) custom-made hard wedges.

Detailed Description

Materials Sim Mom manikin (Laerdal, Stavanger, Norway) Stryker ST104-747(Transport stretcher®, 760 x 2110 mm, 228 kg, Stryker Co., Kalamazoo, Michigan, US) LUCAS Chest Compression System( LUCAS Chest Compression System, Physio-Control/Jolife AB) Backboard(450 ×600 ×10 mm, 3 kg Lifeline Plastic, Sung Shim Medical Co., Bucheon, Korea)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cardiac Arrest

Keywords

Endotracheal intubation, Left lateral tilt wedge, Maternal Cardiopulmonary Resuscitation, Manikin Study

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

19 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Direct laryngoscope

Arm Type

Experimental

Arm Description

Macintosh laryngoscope

Arm Title

Videolaryngoscope-1

Arm Type

Experimental

Arm Description

Glidescope

Arm Title

Videolaryngoscope-2

Arm Type

Experimental

Arm Description

Airwayscope

Intervention Type

Device

Intervention Name(s)

15 degree left-lateral tilt wedges

Other Intervention Name(s)

Custom-made hard wedges

Intervention Description

The wedges are made of aluminium

Intervention Type

Device

Intervention Name(s)

30 degree left-lateral tilt wedges

Other Intervention Name(s)

Custom-made hard wedges

Intervention Description

The wedges are made of aluminium

Primary Outcome Measure Information:

Title

Time to intubation

Description

We will check the times from inserting blade to mouth to exposing vocal cord and from exposing vocal cord to first ambu-bagging.

Time Frame

1day

Title

Success rate of intubation

Description

Definition of failed intubation Time to intubation is longer than 90 seconds. Wrong placement of endotracheal tube (For example : Esophageal intubation etc.)

Time Frame

1day

Secondary Outcome Measure Information:

Title

Laryngeal View during intubation

Description

We will record the best laryngeal View during intubation. We will record according to the Cormack-Lehane Grade system.

Time Frame

1day

Title

The preference for laryngoscopes

Description

Time Frame

1day

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Experience of intubation > 50 times Postgraduates year 1,2,3,4 and Emergency physicians in emergency department Exclusion Criteria: Wrist or Low back disease

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sang hyun Lee, M.D

Organizational Affiliation

Hanyang University Seoul Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hanyang University Seoul Hospital

City

Seoul

ZIP/Postal Code

133792

Country

Korea, Republic of

12. IPD Sharing Statement

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Endotracheal Intubation Using Three Laryngoscopes in Maternal Cardiac Arrest: a Manikin Simulation Study

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