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Status unknownNCT02977559Updated Dec 1, 2016

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

An interventional study of Laryngeal Tube Suction Disposable and Laryngeal Mask Airway AuraGain in Adverse Anesthesia Outcome, sponsored by Bnai Zion Medical Center. Status unknown. Open to participants aged 1 Year to 10 Years. Per ClinicalTrials.gov, last updated 2016-12-01.

Sponsored by Bnai Zion Medical Center · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Nov 2016), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
1 Year to 10 Years
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Adverse Anesthesia Outcome

Keywords

  • Laryngeal Tube Suction Ambu AuraGain Leak Pressure
03

In context

Lead sponsor

Bnai Zion Medical Center is the lead sponsor of 102 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Year to 10 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Investigator)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Laryngeal Tube Suction Disposable

    Laryngeal Tube Suction Disposable for ventilation

    Device: Laryngeal Tube Suction Disposable

  • Experimental
    Laryngeal Mask Airway AuraGain

    Laryngeal Mask Airway AuraGain for oxygenation and ventilation

    Device: Laryngeal Mask Airway AuraGain

Interventions

  • DeviceLaryngeal Tube Suction Disposable

    Device for ventilation

  • DeviceLaryngeal Mask Airway AuraGain

    Ventilation device

06

What researchers measure

Primary outcomes

  1. Leak pressure measure in cm H2O

    Time frame: 60 seconds

Secondary outcomes

  1. Time to insertion a device in seconds

    Time frame: 60 seconds

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 1, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02977559
Lead sponsor
Bnai Zion Medical Center
Responsible party
LUIS.GAITINI (medical doctor, Bnai Zion Medical Center) — Principal investigator
First posted
Nov 30, 2016
Start date
Mar 2017
Primary completion
Apr 2017 (estimated)
Completion
Sep 2017 (estimated)
Last update
Dec 1, 2016

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.

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