Protector™ Versus Supreme® Laryngeal Mask Airway

Study Overview
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Brief Summary
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The goal of this study is to compare the oropharyngeal leak pressure of the Protector Laryngeal mask with the Supreme laryngeal mask. Other secondary parameters will be studied.

Detailed Description
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The OLP as the primary outcome measurement will be evaluated after insertion of the LMA in each group. We hypothesize that there will be a difference of 4 cm H2O between the 2 masks, because of the different material and slightly different form of the masks. Secondary outcomes will be measured after insertion of the LMA as by protocol. Finally postoperative airway morbidity will be evaluated 3 hours after removal of the LMA.

Official Title
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Prospective Randomised Trial of the Protector™ Versus the Supreme® Laryngeal Mask Airway

Conditions
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Anesthesia

Intervention / Treatment
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* Device: Protector
* Device: Supreme


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 18-75 ASA 1-3 Operation on limbs written informed consent Exclusion Criteria: known difficult airway anatomical abnormalities on airway, Larynx, oesophagus, stomach not fastened high aspiration risk patients with contraindication of laryngeal mask BMI >35 kg/m2 patients with disease which impairs accurate Investigation of patient cardiovascular risk factors COPD acute disease where anaesthesia is in doubt no written consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Protector group<br>All patients collocated randomly to the Protector Group Primary and secondary outcome Parameters are studied | Device: Protector<br>* All patients which are assigned to the Protector are studied with this laryngeal mask<br>|
| Placebo Comparator: Supreme group<br>All patients collocated randomly to the Supreme Group, Primary and secondary outcome Parameters are studied | Device: Supreme<br>* All patients which are assigned to the Supreme are studied with this laryngeal mask<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OLP | oropharyngeal leak pressure | 5 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| insertion | insertion of LMA | 5 minutes | 
| time of insertion | time of Insertion of LMA | 5 minutes | 
| Brimacombe score | Brimacombe score | 5 minutes | 
| respiratory pressure | maximum respiratory pressure for adequate ventilation | 5 minutes | 
| suctioning catheter | number needed of insertion of suctioning catheter | 5 minutes | 
| suctioning fluids | ml suctioned from suctioning catheter | 5 minutes | 
| CO2 | endtidal CO2 | 5 minutes | 
| blood staining | visible blood staining after removal of the laryngeal mask | 5 minutes | 
| airway morbidity | assess sore throat, neck pain | 3 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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laryngeal mask, Supreme, Protector