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

Not Applicable

• Conditions: Adverse Anesthesia Outcome
• Interventions: Device: Laryngeal Mask Airway AuraGain; Device: Laryngeal Tube Suction Disposable

• Registration Number: NCT02977559
• Lead Sponsor: Bnai Zion Medical Center

Brief 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.

Detailed 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 Timeline

• Status Verified: 2016-11
• Study First Submitted: 2016-11-28
• Study First Submitted QC: 2016-11-29
• Study First Posted: 2016-11-30
• Last Update Submitted: 2016-11-30
• Last Update Posted: 2016-12-01
• Study Start: 2017-03
• Primary Completion: 2017-04
• Study Completion: 2017-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Laryngeal Mask Airway AuraGain	Laryngeal Mask Airway AuraGain	Laryngeal Mask Airway AuraGain for oxygenation and ventilation
Laryngeal Tube Suction Disposable	Laryngeal Tube Suction Disposable	Laryngeal Tube Suction Disposable for ventilation

Primary Outcome Measures

Name	Time	Method
Leak pressure measure in cm H2O	60 seconds

Secondary Outcome Measures

Name	Time	Method
Time to insertion a device in seconds	60 seconds