Comparison of Ventilation With Bag-Valve-Mask, Laryngeal Tube S-D and Laryngeal Mask Airway Supreme

Study Overview
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Brief Summary
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Inexperienced rescuers may encounter severe problems in an unconscious patient in opening and maintaining an upper airway patent. Gaining evidence which ventilation technique may be most efficient and safe is of utmost importance to potentially improve outcome during cardiopulmonary resuscitation.

Detailed Description
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During cardiopulmonary resuscitation (CPR) ventilation has to be efficient to provide oxygen to the body and safe to avoid potentially fatal regurgitation and aspiration pneumonia and excessive stomach inflation. Basically trained rescuers have severe problems to ventilate a patient during cardiopulmonary resuscitation. This study intends to compare three commonly employed ventilation techniques. First, the traditionally bag-valve mask ventilation is commonly taught during CPR course, despite recent evidence suggesting low efficiency rates. Second, the laryngeal mask and the laryngeal tube supraglottic airways have shown high efficiency and safety in previous studies in the hand of experienced clinicians. Until now it is unclear if basically trained rescuers are better in ventilation with bag valve mask ventilation or the supraglottic airway devices, the laryngeal mask and the laryngeal tube. The purpose of this study is to compare in anesthetised patients airway management and ventilation with bag-valve mask, laryngeal mask and laryngeal tube.

Official Title
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Comparison of Ventilation With Bag-Valve-Mask, Laryngeal Tube S-D and Laryngeal Mask Airway Supreme

Conditions
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Cardiopulmonary Arrest

Intervention / Treatment
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* Device: Bag-Valve-Mask-Ventilation (Ambu Facemask)
* Device: Laryngeal Mask (Laryngeal Mask Airway Supreme)
* Device: Laryngeal Tube (Laryngeal Tube LT-S-D (VBM))


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA I-II -> 18 years old elective surgery in general anesthesia Exclusion Criteria: Patient not sober BMI > 35kg/m2 Pathologies of cerebral spine or peripheral neurological deficit Hiatus hernia, history of gastric reflux Stomach or Esophagus -Operation in the medical history Acute respiratory infection or obstructive lung disease Non elective surgery facial deformity

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 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: Bag-Mask-Ventilation<br>Bag-Valve Mask-Ventilation in 50 patients in general anesthesia | Device: Bag-Valve-Mask-Ventilation (Ambu Facemask)<br>* Bag-Valve Mask-Ventilation<br>* Other names: Ambu Facemask;|
| Active Comparator: Laryngeal Mask Ventilation<br>Laryngeal Mask Ventilation in 50 patients in general anesthesia | Device: Laryngeal Mask (Laryngeal Mask Airway Supreme)<br>* Ventilation<br>* Other names: Laryngeal Mask Airway Supreme;|
| Active Comparator: Laryngeal Tube Ventilation<br>Laryngeal Tube Ventilation in 50 patients in general anesthesia | Device: Laryngeal Tube (Laryngeal Tube LT-S-D (VBM))<br>* Ventilation<br>* Other names: Laryngeal Tube LT-S-D (VBM);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Airway Management time until first effective Ventilation | Effective Ventilation within 90 Seconds required | 90 sec | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stomach inflation | Stomach inflation during ventilation with mask, laryngeal tube an laryngeal mask | 60 sec | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Airway, Bag-Valve -Mask- Ventilation, Laryngeal Mask - Ventilation, Laryngeal Tube - Ventilation