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

Bnai Zion Medical Center

Status

Unknown

Conditions

Adverse Anesthesia Outcome

Treatments

Device: Laryngeal Tube Suction Disposable

Device: Laryngeal Mask Airway AuraGain

Study type

Interventional

Funder types

Other

Identifiers

NCT02977559

BnaiZionMC-16-LG-012

Details and patient eligibility

About

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.

Full 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:

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

Enrollment

60 estimated patients

Sex

All

Ages

1 to 10 years old

Volunteers

No Healthy Volunteers

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.