NCT02878005

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 either blindly or with fiberoptic guidance.This study was designed to assess the success rate of blind and fiberoptic endotracheal intubation using iLTS-D, in comparison with the and Ambu® AuraGain™ in adult patients.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2016

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

August 1, 2016

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

August 15, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 25, 2016

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

August 25, 2016

Status Verified

August 1, 2016

Enrollment Period

Same day

First QC Date

August 15, 2016

Last Update Submit

August 24, 2016

Conditions

Intubation; Difficult

Keywords

Intubating Laryngeal Tubeblind intubationfiberoptic

Outcome Measures

Primary Outcomes (1)

  • Time to performe blind intubation measure in second

    30 seconds

Secondary Outcomes (1)

  • Time to performe fiberoptic intubation in second

    60 seconds

Study Arms (2)

Intubating laryngeal Tube Suction

ACTIVE COMPARATOR

Intubating laryngeal Tube Suction

Device: Intubating Laryngeal Tube SuctionDevice: Ambu AuraGain Laryngeal Mask

Ambu AuraGain Laryngeal Mask

ACTIVE COMPARATOR

Ambu AuraGain Laryngeal Mask

Device: Intubating Laryngeal Tube SuctionDevice: Ambu AuraGain Laryngeal Mask

Interventions

Intubating Laryngeal Tube SuctionDEVICE

Intubating Laryngeal Tube Suction

Ambu AuraGain Laryngeal MaskIntubating laryngeal Tube Suction
Ambu AuraGain Laryngeal MaskDEVICE

Ambu AuraGain Laryngeal Mask

Ambu AuraGain Laryngeal MaskIntubating laryngeal Tube Suction

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Somri M, Hochman O, Gaitini L, Hossein J, Gomez-Rios MA. The intubating laryngeal tube (iLTS-D) versus Ambu(R) Auragain as a conduit facilitating fiberoptic tracheal intubation in adult population: results from a prospective randomized controlled trial. Minerva Anestesiol. 2022 Dec;88(12):1074-1076. doi: 10.23736/S0375-9393.22.16731-3. No abstract available.

    PMID: 36445250DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

August 15, 2016

First Posted

August 25, 2016

Study Start

August 1, 2016

Primary Completion

August 1, 2016

Study Completion

July 1, 2017

Last Updated

August 25, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will share