Comparison Between the Supreme Laryngeal Mask Airway and the Laryngeal Tube Suction During Spontaneous Ventilation

Adverse Anesthesia Outcome Clinical Trial

Official title: A Comparison Between the Supreme Laryngeal Mask Airway and the Laryngeal Tube Suction During Spontaneous Ventilation: A Randomized Prospective Study

Status Completed

Clinical Trial Summary

The study compared the Laryngeal Tube Suction (LTS-D) Disposable with the Supreme Laryngeal Mask Airway (SLMA) during spontaneous ventilation. The investigators hypothesized that the LTS-D and the SLMA perform similarly during spontaneous ventilation despite differences in their structural design.

Clinical Trial Description

The Supreme Laryngeal Mask Airway (SLMA), (Intavent Orthofix, Maidenhead, UK), and Laryngeal Tube Suction -Disposable (LTS-D, (VBM Medizintechnik GmbH, Sulz, Germany), are second generation single-use supraglottic airway devices (SADs) with gastric access, for airway management in spontaneously and mechanically ventilated patients undergoing general anesthesia.

The SLMA has been compared to the Proseal Laryngeal Mask Airway (PLMA) during mechanical and spontaneous ventilation the LTS II (multiple use version of the LTS-D) with the PLMA.

Recently, the LTS-D and SLMA have been compared when used during pressure controlled mechanical ventilation.

To date, there is no published data comparing the SLMA to the LTS-D during spontaneous ventilation. The investigators hypothesized that the SLMA and LTS-D perform similarly during spontaneous ventilation despite differences in their structural design.

The chief aim of this prospective randomized study was to compare the SLMA and the LTS-D with respect to 1) Oxygen saturation and End Tidal carbone dioxide during spontaneous ventilation, 2) time to achieve an effective airway, 3) ease of insertion, 4) need for interventions to achieve an effective airway, 5) cuff seal (leak) pressure at an intracuff pressure of 60 cm H2O, 6) ventilatory variables during spontaneous ventilation, 7) fiberoptic score, 8) adverse perioperative events. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Adverse Anesthesia Outcome

• NCT number: NCT02859922
• Study type: Interventional
• Source: Bnai Zion Medical Center
• Status: Completed
• Phase: N/A
• Start date: January 2009
• Completion date: November 2012