'Single Hand Used inTubaTing Laryngoscope Evaluation' Study

Study Overview
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Brief Summary
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This is a study to compare the new ShuttleScope with the standard Macintosh Laryngoscope

Detailed Description
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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.

Official Title
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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.

Conditions
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Respiratory Failure, Cardiac Arrest, Difficult Intubation, Anesthesia Intubation Complication

Intervention / Treatment
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* Device: ShuttleScope
* Device: MacIntosh Laryngoscope


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success Rate | 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 | 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 | 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 | 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 ] | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Airway management, Videolaryngoscope, Mannequin, Endotracheal Intubation