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The New Intubating Laryngeal Tube Suction-Disposable

B

Bnai Zion Medical Center

Status

Unknown

Conditions

Adverse Anesthesia Outcome

Treatments

Device: AuraGain Laryngeal Mask
Device: Intubation laryngeal Tube Suction

Study type

Interventional

Funder types

Other

Identifiers

NCT02884843
BnaiZionMC-16-LG-004

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 estimated patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • American Society Anesthesiology I and II

Exclusion criteria

  • Difficult intubation, cervical pathology

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

60 participants in 2 patient groups

Intubation laryngeal Tube Suction
Active Comparator group
Description:
Intubation laryngeal Tube Suction Disposable
Treatment:
Device: Intubation laryngeal Tube Suction
AuraGain Laryngeal Mask
Active Comparator group
Description:
AuraGain Laryngeal Mask
Treatment:
Device: AuraGain Laryngeal Mask

Trial contacts and locations

0

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Central trial contact

Mostafa Somri, M.D.; Luis A Gaitini, M.D.

Data sourced from clinicaltrials.gov

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