Adverse Anesthesia Outcome
Conditions
Keywords
Laryngeal Tube Supreme Spontaneous Ventilation
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.
Interventions
Laryngeal Tube Suction Disposable
Supreme Laryngeal Mask Airway
Sponsors
Bnai Zion Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients, American Society of Anesthesiologists ( ASA) physical status I and II, with normal airways for minor elective surgery.
Exclusion criteria
* Age \<18 years, * Weight \<50 kg, * Cervical spine disease limiting neck a known difficult airway, and * Patients with active gastroesophageal reflux.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Sore throat in Numeric Rating Scale. | After the patient was released from Post Anesthesic Care Unit and 24 hours postoperatively. | Sore throat was assessed subjectively by the patient using the 0-10 Numeric Rating Scale. |
Countries
Israel
Outcome results
None listed