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

Adverse Anesthesia Outcome Clinical Trial

Official title:
A Comparative Randomized Prospective Study Between the New Laryngeal Tube Suction-Disposable and the Ambu AuraGain in Pediatric Patients

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02977559
Study type Interventional
Source Bnai Zion Medical Center
Contact
Status Not yet recruiting
Phase N/A
Start date March 2017
Completion date September 2017
View Details
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