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

Not Applicable

Completed

• Conditions: Adverse Anesthesia Outcome
• Interventions: Device: Supreme Laryngeal Mask Airway; Device: Laryngeal Tube Suction Disposable

• Registration Number: NCT02859922
• Lead Sponsor: Bnai Zion Medical Center

Brief 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.

Detailed 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 Timeline

• Study Start: 2009-01
• Primary Completion: 2010-12
• Study Completion: 2012-11
• Study First Submitted: 2016-07-25
• Status Verified: 2016-08
• Study First Submitted QC: 2016-08-04
• Study First Posted: 2016-08-09
• Last Update Submitted: 2016-08-16
• Last Update Posted: 2016-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

Not provided

Exclusion Criteria

• Age <18 years,
• Weight <50 kg,
• Cervical spine disease limiting neck a known difficult airway, and
• Patients with active gastroesophageal reflux.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Supreme Laryngeal Mask Airway	Supreme Laryngeal Mask Airway	Supreme Laryngeal Mask Airway
Laryngeal Tube Suction Disposable	Laryngeal Tube Suction Disposable	Laryngeal Tube Suction Disposable

Primary Outcome Measures

Name	Time	Method
Oxygen saturation in percent	30 min	The data were recorded by the Anesthesia Delivery Unit (Datex-Ohmeda, Helsinki, Finland). monitor from starting the establishment of spontaneous ventilation until the device was removed

Secondary Outcome Measures

Name	Time	Method
Time to achieve an effective airway in sec	15 sec	The time was measured in seconds after the anesthesiologist removed the facemask and insert the device and the square-wave capnograph tracing was observed.Two attempts at insertion were permitted. If unsuccessful the patient's airway was managed with a conventional endotracheal tube.

Trial Locations

Locations (1)

Luis A Gaitini M.D.; 🇮🇱 Haifa, Israel