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

NCT ID: NCT02878005

Last Updated: 2016-08-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2017-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Intubation; Difficult

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intubating laryngeal Tube Suction

Intubating laryngeal Tube Suction

Group Type ACTIVE_COMPARATOR

Intubating Laryngeal Tube Suction

Intervention Type DEVICE

Intubating Laryngeal Tube Suction

Ambu AuraGain Laryngeal Mask

Intervention Type DEVICE

Ambu AuraGain Laryngeal Mask

Ambu AuraGain Laryngeal Mask

Ambu AuraGain Laryngeal Mask

Group Type ACTIVE_COMPARATOR

Intubating Laryngeal Tube Suction

Intervention Type DEVICE

Intubating Laryngeal Tube Suction

Ambu AuraGain Laryngeal Mask

Intervention Type DEVICE

Ambu AuraGain Laryngeal Mask

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Intubating Laryngeal Tube Suction

Intubating Laryngeal Tube Suction

Intervention Type DEVICE

Ambu AuraGain Laryngeal Mask

Ambu AuraGain Laryngeal Mask

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

American Society Anesthesiology I and II

Exclusion Criteria

Difficult intubation, Cervical pathology
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Bnai Zion Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

LUIS.GAITINI

M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

References

Explore related publications, articles, or registry entries linked to this study.

Somri M, Hochman O, Gaitini L, Hossein J, Gomez-Rios MA. The intubating laryngeal tube (iLTS-D) versus Ambu(R) Auragain as a conduit facilitating fiberoptic tracheal intubation in adult population: results from a prospective randomized controlled trial. Minerva Anestesiol. 2022 Dec;88(12):1074-1076. doi: 10.23736/S0375-9393.22.16731-3. No abstract available.

Reference Type DERIVED
PMID: 36445250 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

BnaiZionMC-16-LG-005

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.