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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Adverse Anesthesia Outcome

Intervention / Treatment
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* Device: Laryngeal Tube Suction Disposable
* Device: Supreme Laryngeal Mask Airway


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Supreme Laryngeal Mask Airway<br>Supreme Laryngeal Mask Airway | Device: Supreme Laryngeal Mask Airway<br>* Supreme Laryngeal Mask Airway<br>|
| Active Comparator: Laryngeal Tube Suction Disposable<br>Laryngeal Tube Suction Disposable | Device: Laryngeal Tube Suction Disposable<br>* Laryngeal Tube Suction Disposable<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laryngeal Tube Supreme Spontaneous Ventilation