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NCT02878005 Clinical Trial

A Comparison Between the Intubating Laryngeal Tube Suction and the Ambu AuraGain

Intubation; Difficult Clinical Trial

Official title:
A Prospective and Randomized Study Comparing the New Intubating Laryngeal Tube Suction and the Ambu AuraGain in Adult Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT02878005
Other study ID # BnaiZionMC-16-LG-005
Secondary ID
Status Not yet recruiting
Phase N/A
First received August 15, 2016
Last updated August 24, 2016
Start date August 2016
Est. completion date July 2017

Study information
Verified date August 2016
Source Bnai Zion Medical Center
Contact n/a
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Interventional

Clinical Trial 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.

Description:

The intubating Laryngeal Tube Suction-Disposable (iLTS-D) (VBM Medizintechnik GmbH, 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 fiberoptic guidance. Similarly As in to the LTS-D, the iLTS-D also has a separate channel for the purpose of placement of gastric tubes placement up to a size of 18 Fr.

The iLTS-D comes in one size. According to the depth of insertion, this device is equivalent to size 4 for patients 175patients 175 to 190 cm tall, or size 5 for patients taller than 190 cm. The iLTS-D is provided by the manufacturer with a compatible 7.5mm ETT and with a plastic stabilizer for removal of the device.

The current randomized 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 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: Safety Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• Intubating Laryngeal Tube Suction
Intubating Laryngeal Tube Suction
• Ambu AuraGain Laryngeal Mask
Ambu 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 to performe blind intubation measure in second 30 seconds Yes
Secondary Time to performe fiberoptic intubation in second 60 seconds Yes
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