'Single Hand Used inTubaTing Laryngoscope Evaluation' Study

Respiratory Failure Clinical Trial

— 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.

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04310384
• Other study ID #: 2019/259
• Status: Enrolling by invitation
• Phase: N/A
• Start date: January 22, 2020
• Est. completion date: February 1, 2021

Study information

• Verified date: March 2020
• Source: Basque Country University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 10
• Est. completion date: February 1, 2021
• Est. primary completion date: April 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia Intubation Complication
• Cardiac Arrest
• Difficult Intubation
• Respiratory Failure
• Respiratory Insufficiency

Intervention

Device:
• ShuttleScope
Alternative intervention
• MacIntosh Laryngoscope
Gold Standart

Locations

Country	Name	City	State
Spain	Hospital Virtual, Unidad Docente de Medicina, Facultad de Medicina y Enfermeria de la Universidad del País Vasco (UPV/EHU)	Vitoria	Alava

Sponsors (1)

Lead Sponsor	Collaborator
Basque Country University

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success Rate	Number of succesfull intubations after three attempts	During intubation time, intubation attempts allows maximum 3 times, within 90 sec in each time
Primary	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	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
Secondary	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 ]

External Links

•   Airwaymedicalinnovations