'Single Hand Used inTubaTing Laryngoscope Evaluation' Study (SHUTTLE)

March 13, 2020 updated by: Jose Medrano Laporte, University of the Basque Country (UPV/EHU)

A Randomized Cross-Over Trial to Determine Whether the 'ShuttleScope® Laryngoscope is Inferior, Equal or Superior Compaired to Macintosh Laryngoscope to Perform Successful Endotracheal Intubation in a Manikin Model.

This is a study to compare the new ShuttleScope with the standard Macintosh Laryngoscope

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Following a 5 minutes workshop with an instructor structured demonstration and practice with both devices, the participants attempt intubation in a normal airway scenario with the Macintosh Laryngoscope and the novel ShuttleScope®, in a manikin model.

Study Type

Interventional

Enrollment (Actual)

10

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

  • Spain
    • Alava
      • Vitoria, Alava, Spain, 01007
        • Hospital Virtual, Unidad Docente de Medicina, Facultad de Medicina y Enfermeria de la Universidad del País Vasco (UPV/EHU)

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Medecine students from the Basque Country University (UPV/EHU)

Exclusion Criteria:

  • Other operators different from the ones described above
  • Previous experience with ShuttleScope videolaryngoscope
  • informed consent non available

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: Device Feasibility
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Endotracheal Intubation, gold standart
Standart of Care with Macintosh laryngoscope
Device: MacIntosh Laryngoscope
Gold Standart
Active Comparator: Alternative
Endotracheal Intubation with novel device
Device: ShuttleScope
Alternative intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Success Rate
Time Frame: During intubation time, intubation attempts allows maximum 3 times, within 90 sec in each time
Number of succesfull intubations after three attempts
During intubation time, intubation attempts allows maximum 3 times, within 90 sec in each time
Time to Endotracheal Intubation
Time Frame: During intubation time, intubation attempts allows maximum 3 times, within 90 sec in each time
The duration of intubation is defined as the time from inserting videolaryngoscope, intubating a tube, to withdrawing videolaryngoscope using a stopwatch.
During intubation time, intubation attempts allows maximum 3 times, within 90 sec in each time

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of' oesophageal intubation
Time Frame: During intubation time, intubation attempts allows maximum 3 times, within 90 sec in each time
Number of oesophageal Intubations after three attempts
During intubation time, intubation attempts allows maximum 3 times, within 90 sec in each time
Ease of insertion
Time Frame: During intubation time, intubation attempts allows maximum 3 times, within 90 sec in each time ]
Described by the operator and defined in a subjective visual analogue scale (VAS) from 0 to 10 for each of the devices (0 extremely difficult to 10 extremely easy)
During intubation time, intubation attempts allows maximum 3 times, within 90 sec in each time ]

Collaborators and Investigators

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

Sponsor

University of the Basque Country (UPV/EHU)

Investigators

  • Principal Investigator: Julio Miguel Alonso Babarro, Airwaymedicalinnovations

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.

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)

January 22, 2020

Primary Completion (Anticipated)

April 1, 2020

Study Completion (Anticipated)

February 1, 2021

Study Registration Dates

First Submitted

March 5, 2020

First Submitted That Met QC Criteria

March 13, 2020

First Posted (Actual)

March 17, 2020

Study Record Updates

Last Update Posted (Actual)

March 17, 2020

Last Update Submitted That Met QC Criteria

March 13, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019/259

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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