Trial Comparing the Laryngeal Tube Suction Disposable and the Supreme Laryngeal Mask Airway

Study Overview
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Brief Summary
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The investigators study compared the Laryngeal Tube Suction-Disposable with the Supreme Laryngeal Mask Airway, hypothesizing that the two devices would provide adequate oropharyngeal seal pressure in different head and neck positions and perform similarly during pressure controlled ventilation in neutral position, despite differences in their structural design.

Detailed Description
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Laryngeal Tube Suction Disposable, LTS-D (VBM Medizintechnik GmbH , Sulz, Germany) and Supreme Laryngeal Mask Airway, SLMA (Intavent Orthofix, Maidenhead, UK) are second generation, single-use, supraglottic airway devices( SADs), with added gastric access, for use in spontaneously and mechanically ventilated patients undergoing general anesthesia. The effectiveness of the LTS-D and the SLMA has been well established; however, the oropharyngeal seal pressure of both devices in different head/neck positions and the performance of these devices using positive pressure ventilation have not been evaluated. Changing the head/neck position can alter the sealing capabilities of the SAD. To the investigators best knowledge there are no studies comparing the oropharyngeal seal pressure in different head and neck position when using these devices.

Official Title
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A Randomized Prospective Controlled Trial Comparing the Laryngeal Tube Suction Disposable and the Supreme Laryngeal Mask Airway: The Influence of Head and Neck Position on Oropharyngeal Seal Pressure

Conditions
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Adverse Anesthesia Outcome

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients ASA I and II with normal airways, for minor elective surgical Exclusion Criteria: Age <18 yr, weight <50 kg, or > 100 kg , a known difficult airway, active gastro esophageal reflux disease

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: Parallel 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>Device: Laryngeal Tube Suction Disposable<br>* Laryngeal Tube Suction Disposable<br>|
| Active Comparator: Laryngeal Tube Suction Disposable<br>Laryngeal Tube Suction Disposable | Device: Supreme Laryngeal Mask Airway<br>* Supreme Laryngeal Mask Airway<br>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 |
| --- | --- | --- |
| Primary outcome oropharyngeal seal pressures, in cm H2O | Oropharyngeal leak pressure was determined by closing the expiratory valve of the anesthesia breathing system and a fixed gas flow of the 3 liters minute. The airway pressure at which an equilibrium was reached was noted( maximun allowed 40 cm H2O) | 5 min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fiberoptic position | Scoring system of the fiberoptic view: ranged from grade 4 (full view of arytenoids and glottis), 3 (arytenoids and glottis partly visible), 2 (view of arytenoids, glottis or epiglottis), and 1 (no part of larynx identifiable). | 5 min | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laryngeal Tube Supreme Laryngeal Mask Airway Leak Pressure