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The New Intubating Laryngeal Tube Suction-Disposable

A Comparative Randomized Prospective Study Between the New Intubating Laryngeal Tube Suction-Disposable and the Ambu AuraGain in Blind and Fibreoptic-guided Intubation

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02884843
Enrollment
60
Registered
2016-08-31
Start date
2016-08-31
Completion date
2017-07-31
Last updated
2016-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adverse Anesthesia Outcome

Keywords

Laryngeal Tube, blind intubation, fiberoptic

Brief summary

The study compares the intubating Laryngeal Tube Suction (iLTS-D) with the Ambu®AuraGain™ in blind and fibreoptic endotracheal intubation. The current randomized study is designed to assess the success rate of blind and fibreoptic endotracheal intubation using i-LTS-D, in comparison with the Air-Q, i-gel® and Ambu®AuraGain™ in an airway simulator. The investigators hypothesize that the iLTS-D and the Supreme Laryngeal Mask Airway will similarly perform during spontaneous ventilation despite differences in their structural design.

Detailed description

The intubating Laryngeal Tube Suction-Disposable (iLTS-D) (VBM Medizintechnik, Sulz, Germany) is a new updated version of the Laryngeal Tube-Suction Disposable (LTS-D). It has a ventilator channel with a 13.5mm internal diameter, which enables the passage of an Endotracheal Tube (ETT) either blindly or with fibreoptic guidance. Similarly to the LTS-D, the iLTS-D also has a separate channel for gastric tubes placement up to a size of 18 Fr. The current randomized study was designed to assess the success rate of blind and fibreoptic endotracheal intubation using iLTS-D, in comparison with the Ambu® AuraGain™ in adult patients under general anesthesia.

Interventions

DEVICEIntubation laryngeal Tube Suction

Intubation laryngeal Tube Suction

DEVICEAuraGain Laryngeal Mask

AuraGain Laryngeal Mask

Sponsors

Bnai Zion Medical Center
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

* American Society Anesthesiology I and II

Exclusion criteria

* Difficult intubation, cervical pathology

Design outcomes

Primary

MeasureTime frame
Time of blind intubation measure in seconds30 seconds

Secondary

MeasureTime frame
Time of Fiberoptic intubation measure in seconds60 seconds

Contacts

Primary ContactLuis A Gaitini, M.D.
luis.gaitini@b-zion.org.il# 972 4 8359346
Backup ContactMostafa Somri, M.D.
mostafa.somri@b-zion.org.il# 972 4 8359304

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026