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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supreme Laryngeal Mask Airway | Active Comparator | Supreme Laryngeal Mask Airway |
|
| Laryngeal Tube Suction Disposable | Active Comparator | Laryngeal Tube Suction Disposable |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laryngeal Tube Suction Disposable | Device | Laryngeal Tube Suction Disposable |
|
| Measure | Description | Time Frame |
|---|---|---|
| Oxygen saturation in percent | 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 | 30 min |
| Measure | Description | Time Frame |
|---|---|---|
| Time to achieve an effective airway in 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. | 15 sec |
| Measure | Description | Time Frame |
|---|---|---|
| Sore throat in Numeric Rating Scale. | Sore throat was assessed subjectively by the patient using the 0-10 Numeric Rating Scale. | After the patient was released from Post Anesthesic Care Unit and 24 hours postoperatively. |
Inclusion criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Luis A Gaitini, M.D. | Bnai Zion Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Luis A Gaitini M.D. | Haifa | Israel |
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| Supreme Laryngeal Mask Airway | Device | Supreme Laryngeal Mask Airway |
|