A Comparison of a Macintosh Laryngoscope and Endotracheal Tube Introducer in a Manikin

March 28, 2018 updated by: Hüseyin Cahit Halhallı, Derince Training and Research Hospital

Comparison of a Macintosh Laryngoscope and Endotracheal Tube Introducer During Chest Compression in a Manikin: Randomized, Prospective, Cross-over Study

In this prospective, randomized, cross-over study, investigators aimed to compare the first pass successes of inexperienced doctors with Macintosh laryngoscopy and endotracheal tube introducer on a manikin with continuous chest compression in the ambulance simulation in the pre-hospital process.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study is a prospective, cross-over manikin study which is based on an ambulance simulation. Written inform consent was obtained from all doctors who agreed to participate to the study. Inexperienced doctors who attended in Kocaeli between February 2018 and March 2018 will be included to the survey. Novice doctors participated to this research. The research will be carried out in the department of emergency medicine of Derince training and research hospital. In order to prevent bias, the eight-hour training module for the participants , theoretical and practical airway training will be provided by an emergency medical specialist who has no knowledge about the research.

The participants will be informed about the study after the training. Doctors who participate to the study will be included after the written inform consent is obtained. The participants will be informed about the research, but they will be blind to the specific purposes of the study. The participants will practice for 5 minutes on the manikin by themselves and with the emergency medicine specialist if they ask for. Life / form® Deluxe Crisis ™ Manikin Torso with Advanced Airway Management will be used as the research manikin. The participants will perform airway interventions in the sitting position and the height of the stretcher will be set at the same height with the ambulance stretcher. Practitioner's seat will be set on the same height with the ambulance seat. 8.0 (mm ID) endotracheal tube will be used for the procedure. Endotracheal tube and manikin airway will be lubricated with pump spray lubricant provided with the simulator. Airway manikin will be in supine position. Lund University Cardiac Arrest System-version 2 (LUCAS 2TM) automatic chest compression device will be used to provide 5 cm compression depth and 100 chest compressions per minute in order to provide standardization in chest compression and prevent bias created by practitioners. The airway devices will be next to the model's head.

The study was planned as a randomized, crossover clinical trial to reduce the influence of the learning. Equal numbers 1 and 2 will be written on the same sized papers to provide randomization. All papers will be folded in the same way and placed inside brown and invisible envelopes. All of the envelopes will be placed in the same box. After the training, every doctor will be asked to choose one of the envelopes. After separating the participants into two groups, doctors that drawed envelop number 1 will be asked to intubate by using only No. 3 Macintosh blade. The doctors that drawed envelop number 2 will be asked to intubate with the adult size endotracheal tube introducer with using No. 3 Macintosh laryngoscopy.

After the groups completed their interventions, those who drawed envelope number 1 will be asked to intubate with Macintosh laryngoscopy using endotracheal tube introducer and those who drawed envelope number 2 will be asked to intubate with Macintosh laryngoscopy. Each doctor will be given 1 minute for each successful intervention. Each practitioner will make maximum 2 trial attempts for each method. The initiation time is considered to be taking the laryngoscopy on hand. After ventilation, the manikin's chest wall movement is considered as a successful intervention. All transactions will be recorded with a camera that is placed in the room and the participants will have the information about the presence of the camera. The first intervention success , intubation time, the number of interventions of the participants will be recorded. After the interventions are over, the participants will be asked to rate the difficulty of the ventilation methods according to the Likert scale as 1-very easy, 2-easy, 3-medium, 4-difficult 5- very difficult. In addition, they will be asked whether they have any experiences with Macintosh laryngoscopy or endotracheal tube introducer and their responses will be recorded.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Derince
      • Kocaeli, Derince, Turkey, 41300
        • Derince training and educational hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • novice doctors who accept to participate the study

Exclusion Criteria:

  • novice doctors who won't accept to participate the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Macintosh group
After separating participants into two groups, doctors that drawed envelop number 1 will be asked to intubate with laryngoscope by using No. 3 Macintosh laryngoscope
Device: Macintosh laryngoscopy
The doctors who drawed envelope number 1 will asked to intubate with using No. 3 Macintosh blade
Active Comparator: Endotracheal tube introducer group
After separating participants into two groups, doctors that drawed envelop number 2 will be asked to intubate with laryngoscope by using the adult size endotracheal tube introducer with using No. 3 Macintosh laryngoscope.
Device: Endotracheal tube introducer
The doctors that drawed envelop number 2 will be asked to intubate with laryngoscope by the adult size, endotracheal tube introducer with using No. 3 Macintosh blade

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
First pass success
Time Frame: 1 minute
The primary outcome measure of the survey is determined as the first pass success of the doctors.
1 minute

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
intubation duration
Time Frame: 1 minute
The initiation time is considered to be taking the laryngoscope on hand. Successful ventilation of the manikin with a balloon valve mask is considered as the ending time of the intervention.
1 minute
Intervention numbers
Time Frame: 1 minute
All of the interventions will be recorded with a camera
1 minute
Difficulty levels of the methods
Time Frame: 2 minutes
Difficulty levels of the methods on the Likert scale.
2 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Derince Training and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 10, 2018

Primary Completion (Actual)

March 10, 2018

Study Completion (Actual)

March 10, 2018

Study Registration Dates

First Submitted

January 18, 2018

First Submitted That Met QC Criteria

January 26, 2018

First Posted (Actual)

February 5, 2018

Study Record Updates

Last Update Posted (Actual)

March 29, 2018

Last Update Submitted That Met QC Criteria

March 28, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2017/16. 15/351

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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