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

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

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.

Study Overview

• Status: Unknown
• Conditions: Adverse Anesthesia Outcome
• Intervention / Treatment: Device: Laryngeal Tube Suction Disposable; Device: Laryngeal Mask Airway AuraGain

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 10 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Laryngeal Tube Suction Disposable; Laryngeal Tube Suction Disposable for ventilation	Device: Laryngeal Tube Suction Disposable; Device for ventilation
Experimental: Laryngeal Mask Airway AuraGain; Laryngeal Mask Airway AuraGain for oxygenation and ventilation	Device: Laryngeal Mask Airway AuraGain; Ventilation device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Leak pressure measure in cm H2O	60 seconds

Secondary Outcome Measures

Outcome Measure	Time Frame
Time to insertion a device in seconds	60 seconds

Collaborators and Investigators

• Sponsor: Bnai Zion Medical Center

Study record dates

Study Major Dates

• Study Start: March 1, 2017
• Primary Completion (Anticipated): April 1, 2017
• Study Completion (Anticipated): September 1, 2017

Study Registration Dates

• First Submitted: November 28, 2016
• First Submitted That Met QC Criteria: November 29, 2016
• First Posted (Estimate): November 30, 2016

Study Record Updates

• Last Update Posted (Estimate): December 1, 2016
• Last Update Submitted That Met QC Criteria: November 30, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: Laryngeal Tube Suction Ambu AuraGain Leak Pressure
• Other Study ID Numbers: BnaiZionMC-16-LG-012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES