The New Intubating Laryngeal Tube Suction-Disposable

Not Applicable

• Conditions: Adverse Anesthesia Outcome
• Interventions: Device: Intubation laryngeal Tube Suction; Device: AuraGain Laryngeal Mask

• Registration Number: NCT02884843
• Lead Sponsor: Bnai Zion Medical Center

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.

Study Timeline

• Status Verified: 2016-08
• Study Start: 2016-08
• Primary Completion: 2016-08
• Study First Submitted: 2016-08-15
• Study First Submitted QC: 2016-08-30
• Last Update Submitted: 2016-08-30
• Study First Posted: 2016-08-31
• Last Update Posted: 2016-08-31
• Study Completion: 2017-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• American Society Anesthesiology I and II

Exclusion Criteria

• Difficult intubation, cervical pathology

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Intubation laryngeal Tube Suction	Intubation laryngeal Tube Suction	Intubation laryngeal Tube Suction Disposable
AuraGain Laryngeal Mask	AuraGain Laryngeal Mask	AuraGain Laryngeal Mask

Primary Outcome Measures

Name	Time	Method
Time of blind intubation measure in seconds	30 seconds

Secondary Outcome Measures

Name	Time	Method
Time of Fiberoptic intubation measure in seconds	60 seconds