NCT05347680

Brief Summary

The intubating Laryngeal Tube Suction-Disposable is a new version of the Laryngeal Tube-Suction. It has a ventilator channel with a 13.5mm internal diameter, which enables the passage of an Endotracheal Tube with fiberoptic guidance. This study was designed to assess the Time fiberoptic endotracheal intubation using iLTS-D, in comparison with the and Ambu® AuraGain™ in adult patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2019

Geographic Reach
1 country

1 active site

Status
completed

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

September 19, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 18, 2021

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

April 3, 2022

Completed
23 days until next milestone

First Posted

Study publicly available on registry

April 26, 2022

Completed
Last Updated

April 26, 2022

Status Verified

April 1, 2022

Enrollment Period

4 months

First QC Date

April 3, 2022

Last Update Submit

April 20, 2022

Conditions

Difficult Intubation

Keywords

fiberopticsupraglotticLaryngeal Tubeintubation

Outcome Measures

Primary Outcomes (1)

  • Time to perform fiberoptic intubation through supraglottic device in second

    Time to perform endotracheal fiberoptic intubation through supraglottic device in second

    120 seconds

Secondary Outcomes (1)

  • Success to obtain fiberoptic intubation through supraglottic device in second

    120 seconds

Study Arms (2)

intubating laryngeal Tube Suction

ACTIVE COMPARATOR

Fiberoptic Intubation through intubating laryngeal Tube Suction

Device: Intubating Laryngeal Tube Suction

Ambu AuraGain Laryngeal Mask

ACTIVE COMPARATOR

Fiberoptic Intubation through Ambu AuraGain Laryngeal Mask

Device: Ambu AuraGain Laryngeal Mask

Interventions

Intubating Laryngeal Tube SuctionDEVICE

Intubating Laryngeal Tube Suction

intubating laryngeal Tube Suction
Ambu AuraGain Laryngeal MaskDEVICE

Ambu AuraGain Laryngeal Mask

Ambu AuraGain Laryngeal Mask

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • American Society Anesthesiology I and II

You may not qualify if:

  • Difficult intubation
  • Cervical pathology
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Luis A Gaitini M.D.

Haifa, Israel

Location

Study Officials

  • Luis Gaitini, Prof

    Bani Zion Medical Center Haifa ISRAEL

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 3, 2022

First Posted

April 26, 2022

Study Start

September 19, 2019

Primary Completion

January 15, 2020

Study Completion

January 18, 2021

Last Updated

April 26, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)