Ignite Creation Date:
2025-12-24 @ 2:28 PM
Ignite Modification Date:
2026-01-03 @ 6:58 PM
Study NCT ID:
NCT02977559
Status:
UNKNOWN
Last Update Posted:
2016-12-01
First Post:
2016-11-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study Between the Laryngeal Tube Suction-Disposable and the Ambu AuraGain in Pediatric Patients
Sponsor:
Bnai Zion Medical Center
Organization:
Study Overview
Official Title:
A Comparative Randomized Prospective Study Between the New Laryngeal Tube Suction-Disposable and the Ambu AuraGain in Pediatric Patients
Status:
UNKNOWN
Status Verified Date:
2016-11
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: