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NCT02884843 Clinical Trial

The New Intubating Laryngeal Tube Suction-Disposable

Adverse Anesthesia Outcome Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT02884843
Other study ID # BnaiZionMC-16-LG-004
Secondary ID
Status Not yet recruiting
Phase N/A
First received August 15, 2016
Last updated August 30, 2016
Start date August 2016
Est. completion date July 2017

Study information
Verified date August 2016
Source Bnai Zion Medical Center
Contact Luis A Gaitini, M.D.
Phone # 972 4 8359346
Email luis.gaitini@b-zion.org.il
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 60
Est. completion date July 2017
Est. primary completion date August 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria:

- American Society Anesthesiology I and II

Exclusion Criteria:

- Difficult intubation, cervical pathology

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

Intervention

Device:
• Intubation laryngeal Tube Suction
Intubation laryngeal Tube Suction
• AuraGain Laryngeal Mask
AuraGain Laryngeal Mask

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Bnai Zion Medical Center

Outcome
Type Measure Description Time frame Safety issue
Primary Time of blind intubation measure in seconds 30 seconds Yes
Secondary Time of Fiberoptic intubation measure in seconds 60 seconds Yes
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