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Clinical Trials/NCT02859922
NCT02859922
Completed
Not Applicable

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

Bnai Zion Medical Center1 site in 1 country180 target enrollmentJanuary 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Adverse Anesthesia Outcome
Sponsor
Bnai Zion Medical Center
Enrollment
180
Locations
1
Primary Endpoint
Oxygen saturation in percent
Status
Completed
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2009
End Date
November 2012
Last Updated
9 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

LUIS.GAITINI

M.D.

Bnai Zion Medical Center

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Oxygen saturation in percent

Time Frame: 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 Outcomes

  • Time to achieve an effective airway in sec(15 sec)

Study Sites (1)

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