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A Study Between the Laryngeal Tube Suction-Disposable and the Ambu AuraGain in Pediatric Patients

NCT ID: NCT02977559

Last Updated: 2016-12-01

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

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-31

Study Completion Date

2017-09-30

Brief Summary

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The study compared the Laryngeal Tube Suction Disposable (LTS-D) with the Disposable Laryngeal Mask Ambu® AuraGain™ (DLMA AG) during general anesthesia in pediatric patients.

The investigators hypothesized that the LTS-D and the DLMA AG performed similarly during mechanical ventilation despite differences in their structural design.

Detailed Description

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The Laryngeal Tube Suction-Disposable (LTS-D, (VBM Medizintechnik GmbH, Sulz, Germany), is a second generation single-use supraglottic airway devices (SADs) with gastric access, for airway management in spontaneously and mechanically ventilated patients undergoing general anesthesia.

The AuraGain is a second generation laryngeal mask, satisfying airway management needs by integrating gastric access and ventilation capability in an anatomically curved single-use device that facilitates rapid establishment of a safe airway.

The two devices have now pediatric sizes.

To date, there is no published data comparing the LTS-D and the DLMA AG during mechanical ventilation in pediatric patients. The investigators hypothesized that the LTS-D and the DLMA AG perform similarly during mechanical ventilation despite differences in their structural design.

The chief aim of this prospective randomized study was to compare the LTS-D and the DLMA AG with respect to:

1. time to achieve an effective airway,
2. ease of insertion,
3. need for interventions to achieve an effective airway,
4. cuff seal (leak) pressure at an intracuff pressure of 60 cm H2O,
5. ventilatory variables during mechanical ventilation,
6. fiberoptic score,
7. gastric tube insertion and
8. adverse perioperative events.

Conditions

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Adverse Anesthesia Outcome

Keywords

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Laryngeal Tube Suction Ambu AuraGain Leak Pressure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Laryngeal Tube Suction Disposable

Laryngeal Tube Suction Disposable for ventilation

Group Type EXPERIMENTAL

Laryngeal Tube Suction Disposable

Intervention Type DEVICE

Device for ventilation

Laryngeal Mask Airway AuraGain

Laryngeal Mask Airway AuraGain for oxygenation and ventilation

Group Type EXPERIMENTAL

Laryngeal Mask Airway AuraGain

Intervention Type DEVICE

Ventilation device

Interventions

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Laryngeal Tube Suction Disposable

Device for ventilation

Intervention Type DEVICE

Laryngeal Mask Airway AuraGain

Ventilation device

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Pediatric patients, American Society of Anesthesiologist (ASA) physical status I and II weighing 30 to 10 kg, posted for abdominal surgery under general anesthesia.

Exclusion Criteria

* Infants with active respiratory tract infection anticipated and known difficult airway, lung disease requiring high positive end expiratory pressure, and active gastrointestinal reflux will be excluded.
Minimum Eligible Age

1 Year

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bnai Zion Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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LUIS.GAITINI

medical doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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BnaiZionMC-16-LG-012

Identifier Type: -

Identifier Source: org_study_id