'Single Hand Used inTubaTing Laryngoscope Evaluation' Study

Not Applicable

• Conditions: Respiratory Failure; Difficult Intubation; Cardiac Arrest; Anesthesia Intubation Complication
• Interventions: Device: MacIntosh Laryngoscope; Device: ShuttleScope

• Registration Number: NCT04310384
• Lead Sponsor: University of the Basque Country (UPV/EHU)

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.

Study Timeline

• Study Start: 2020-01-22
• Status Verified: 2020-03
• Study First Submitted: 2020-03-05
• Study First Submitted QC: 2020-03-13
• Last Update Submitted: 2020-03-13
• Study First Posted: 2020-03-17
• Last Update Posted: 2020-03-17
• Primary Completion: 2020-04-01
• Study Completion: 2021-02-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Endotracheal Intubation, gold standart	MacIntosh Laryngoscope	Standart of Care with Macintosh laryngoscope
Alternative	ShuttleScope	Endotracheal Intubation with novel device

Primary Outcome Measures

Name	Time	Method
Success Rate	During intubation time, intubation attempts allows maximum 3 times, within 90 sec in each time	Number of succesfull intubations after three attempts
Time to Endotracheal Intubation	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.

Secondary Outcome Measures

Name	Time	Method
Ease of insertion	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)
Incidence of' oesophageal intubation	During intubation time, intubation attempts allows maximum 3 times, within 90 sec in each time	Number of oesophageal Intubations after three attempts

Trial Locations

Locations (1)

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