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Clinical Trials/NCT04618926
NCT04618926UnknownNot Applicable

A Prospective Randomized Study Comparing Fiberoptic Bronchoscope Endotracheal Intubation Between the Intubating Laryngeal Tube Suction and the LMA Protector

Bnai Zion Medical Center0 sites80 target enrollmentStarted: April 1, 2021Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
80
Primary Endpoint
time of success fiberoptic endotracheal intubation

Study Overview

Brief Summary

Securing the airway is a pivotal skill for anesthesiologists and emergency care providers. Endotracheal intubation (ETI) is considered the gold standard for securing the airway.

When ETI via laryngoscopy has failed, the use of a supraglottic airway device (SGAD) has been recommended. The intubating Laryngeal Tube Suction-Disposable and the LMA Protector are a new step in the evolution of supraglottic airways. Both SGADs are enable to ventilation and oxygenation, but the ventilation channel allow the insertion of an endotracheal tube and the use of fiberoptic bronchoscope. The aim of this study is to compare the time of fiberoptic intubation through the intubating Laryngeal Tube Suction Disposable and the LMA Protector in adult patients.

Detailed Description

Detailed Description: Securing the airway is a pivotal skill for anesthesiologist and emergency providers. Endotracheal intubation (ETI) is considered the gold standard for securing the airway. Induction time during anesthesia may sometimes present unexpected difficulties during ETI.

When ETI via laryngoscopy has failed, the use of a supraglottic airway device (SGAD) has been recommended. Previous studies suggested that compare intubation with laryngoscope, SGADs enables rapid and effective airway control. Improved second generation SGADs enable ventilation and oxygenation, but also include a second channel that separates the trachea from the esophagus preventing aspiration. According with the results of the Fourth National Audit Project of the Royal College of Anesthetist will bets and the Difficult Airway Society, the second generation SGADs should be uses instead the first generation.

Some of the second generations of SGADs have a ventilation channel that allow the insertion of an endotracheal tube.

Two of these devices recently introduced in the market are the intubating Laryngeal Tube Suction Disposable (iLTS-D) and the Laryngeal Mask Airway Protector [5, 6] The intubating Laryngeal Tube Suction- Disposable (iLTS-D) (VBM, Germany) is a new updated version of the Laryngeal Tube-Suction Disposable (LTS-D). [5] It has a ventilator channel with a 13.5mm internal diameter, which enables the passage of an Endotracheal Tube (ETT) No 7.5 mm. for fiberoptic 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 device is latex free, made of PVC, and like the original laryngeal tube (LT), can be inserted blindly.

The iLTS-D comes in one size. According to the depth of insertion, the device will be equivalent to size 4 for patients 175 to 190 cm tall, or size 5 for patients taller than 190 cm.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

time of success fiberoptic endotracheal intubation

Time Frame: 60 seconds

seconds

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other Gov
Responsible Party
Principal Investigator
Principal Investigator

LUIS.GAITINI

Associate Clinical Professor of Anesthesiology

Bnai Zion Medical Center

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