NCT04310384

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 22, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 5, 2020

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 17, 2020

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2020

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2021

Completed
Last Updated

March 17, 2020

Status Verified

March 1, 2020

Enrollment Period

2 months

First QC Date

March 5, 2020

Last Update Submit

March 13, 2020

Conditions

Keywords

Airway managementVideolaryngoscopeMannequinEndotracheal Intubation

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • Incidence of' oesophageal intubation

    During intubation time, intubation attempts allows maximum 3 times, within 90 sec in each time

  • Ease of insertion

    During intubation time, intubation attempts allows maximum 3 times, within 90 sec in each time ]

Study Arms (2)

Endotracheal Intubation, gold standart

ACTIVE COMPARATOR

Standart of Care with Macintosh laryngoscope

Device: MacIntosh Laryngoscope

Alternative

ACTIVE COMPARATOR

Endotracheal Intubation with novel device

Device: ShuttleScope

Interventions

Alternative intervention

Alternative

Gold Standart

Endotracheal Intubation, gold standart

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Vitoria-Gasteiz, Alava, 01007, Spain

Location

Related Links

MeSH Terms

Conditions

Respiratory InsufficiencyHeart Arrest

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesHeart DiseasesCardiovascular Diseases

Study Officials

  • Julio Miguel Alonso Babarro

    Airwaymedicalinnovations

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD

Study Record Dates

First Submitted

March 5, 2020

First Posted

March 17, 2020

Study Start

January 22, 2020

Primary Completion

April 1, 2020

Study Completion

February 1, 2021

Last Updated

March 17, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations