A Prospective and Randomized Study Comparing the New Intubating Laryngeal Tube Suction and the Ambu AuraGain in Adult Patients
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Bnai Zion Medical Center
- Enrollment
- 60
- Primary Endpoint
- Time to performe blind intubation measure in second
Study Overview
Brief 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.
Detailed 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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •American Society Anesthesiology I and II
Exclusion Criteria
- •Difficult intubation, Cervical pathology
Arms & Interventions
Intubating laryngeal Tube Suction
Intubating laryngeal Tube Suction
Intervention: Intubating Laryngeal Tube Suction (Device)
Intubating laryngeal Tube Suction
Intubating laryngeal Tube Suction
Intervention: Ambu AuraGain Laryngeal Mask (Device)
Ambu AuraGain Laryngeal Mask
Ambu AuraGain Laryngeal Mask
Intervention: Intubating Laryngeal Tube Suction (Device)
Ambu AuraGain Laryngeal Mask
Ambu AuraGain Laryngeal Mask
Intervention: Ambu AuraGain Laryngeal Mask (Device)
Outcomes
Primary Outcomes
Time to performe blind intubation measure in second
Time Frame: 30 seconds
Secondary Outcomes
- Time to performe fiberoptic intubation in second(60 seconds)
Investigators
LUIS.GAITINI
M.D.
Bnai Zion Medical Center