Back to results'Single Hand Used inTubaTing Laryngoscope Evaluation' Study (SHUTTLE)
Primary Purpose
Respiratory Failure, Cardiac Arrest, Difficult Intubation
Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
ShuttleScope
MacIntosh Laryngoscope
Sponsored by
About this trial
This is an interventional device feasibility trial for Respiratory Failure focused on measuring Airway management, Videolaryngoscope, Mannequin, Endotracheal Intubation
Eligibility Criteria
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
Sites / Locations
- Hospital Virtual, Unidad Docente de Medicina, Facultad de Medicina y Enfermeria de la Universidad del País Vasco (UPV/EHU)
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Endotracheal Intubation, gold standart
Alternative
Arm Description
Standart of Care with Macintosh laryngoscope
Endotracheal Intubation with novel device
Outcomes
Primary Outcome Measures
Success Rate
Number of succesfull intubations after three attempts
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.
Secondary Outcome Measures
Incidence of' oesophageal intubation
Number of oesophageal Intubations after three attempts
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)
Full Information
NCT ID
NCT04310384
First Posted
March 5, 2020
Last Updated
March 13, 2020
Sponsor
University of the Basque Country (UPV/EHU)
1. Study Identification
Unique Protocol Identification Number
NCT04310384
Brief Title
'Single Hand Used inTubaTing Laryngoscope Evaluation' Study
Acronym
SHUTTLE
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 22, 2020 (Actual)
Primary Completion Date
April 1, 2020 (Anticipated)
Study Completion Date
February 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of the Basque Country (UPV/EHU)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a study to compare the new ShuttleScope with the standard Macintosh Laryngoscope
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Failure, Cardiac Arrest, Difficult Intubation, Anesthesia Intubation Complication
Keywords
Airway management, Videolaryngoscope, Mannequin, Endotracheal Intubation
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Endotracheal Intubation, gold standart
Arm Type
Active Comparator
Arm Description
Standart of Care with Macintosh laryngoscope
Arm Title
Alternative
Arm Type
Active Comparator
Arm Description
Endotracheal Intubation with novel device
Intervention Type
Device
Intervention Name(s)
ShuttleScope
Intervention Description
Alternative intervention
Intervention Type
Device
Intervention Name(s)
MacIntosh Laryngoscope
Intervention Description
Gold Standart
Primary Outcome Measure Information:
Title
Success Rate
Description
Number of succesfull intubations after three attempts
Time Frame
During intubation time, intubation attempts allows maximum 3 times, within 90 sec in each time
Title
Time to Endotracheal Intubation
Description
The duration of intubation is defined as the time from inserting videolaryngoscope, intubating a tube, to withdrawing videolaryngoscope using a stopwatch.
Time Frame
During intubation time, intubation attempts allows maximum 3 times, within 90 sec in each time
Secondary Outcome Measure Information:
Title
Incidence of' oesophageal intubation
Description
Number of oesophageal Intubations after three attempts
Time Frame
During intubation time, intubation attempts allows maximum 3 times, within 90 sec in each time
Title
Ease of insertion
Description
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)
Time Frame
During intubation time, intubation attempts allows maximum 3 times, within 90 sec in each time ]
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julio Miguel Alonso Babarro
Organizational Affiliation
Airwaymedicalinnovations
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Virtual, Unidad Docente de Medicina, Facultad de Medicina y Enfermeria de la Universidad del País Vasco (UPV/EHU)
City
Vitoria
State/Province
Alava
ZIP/Postal Code
01007
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://airwaymedicalinnovations.com/
Description
Airwaymedicalinnovations
Learn more about this trial
'Single Hand Used inTubaTing Laryngoscope Evaluation' Study
We'll reach out to this number within 24 hrs