Comparison of Two Ventilation Modes With Laryngeal Mask Airway Guardian

Study Overview
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Brief Summary
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The purpose of this study is to compare volume- and pressure- controlled ventilation with laryngeal mask airway Guardian in obese patients undergoing laparoscopic gynecologic surgery in terms of ventilatory efficacy, airway leak pressure (airway protection), ease-of-use and complications.

Detailed Description
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The Guardian Laryngeal Mask (Ultimate Medical Pty Ltd, Richmond, Vic, Australia) is a new silicone-based single-use extraglottic airway device that forms a seal with the glottis for ventilation and with the hypopharynx for airway protection, and provides a gastric drainage port. The aim of the following perspective, randomized, blind trial study id to compare how the volume-controlled ventilation and pressure-controlled ventilation modes using the Laryngeal Mask Guardian affect the pulmonary mechanics, the gas exchange and the cardiovascular responses particularly in obese patients undergoing gynecological laparoscopy.

Official Title
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Comparison of Volume- and Pressure- Controlled Ventilation With Laryngeal Mask Airway Guardian in Obese Patients Undergoing Laparoscopic Gynecologic Surgery-A Perspective, Randomized, Blind Trial

Conditions
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Gynecologic Disease

Intervention / Treatment
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* Procedure: tidal volume
* Procedure: peak airway pressure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ambulatory patients scheduled to undergo laparoscopic gynecologic surgery under a short general paralysed anesthesia of less than 2 hours (ASA physical status I-II) 18 to 65 years of age A body mass index <40 kg • m-2 Exclusion Criteria: Difficult airway Recent history of upper respiratory tract infection and sore throats A history of esophageal reflux disease Kinesia patients Inability to understand the Study Information Sheet and provide a written consent to take part in the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

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

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: pressure-controlled ventilation<br>pressure-controlled ventilation: a peak airway pressure that provided a tidal volume of 8-12ml/kg with an upper limit of 35 centimeter water column, respiratory rate 12-16 times per minute. | Procedure: peak airway pressure<br>* In the pressure controlled ventilation group using laryngeal mask airway Guardian,a peak airway pressure that provides a tidal volume of 8-12ml/kg with an upper limit of 35 centimeter water column,respiratory rate12-16bpm.<br>* Other names: peak pressure of aieway;|
| Experimental: volume-controlled ventilation<br>volume-controlled ventilation: tidal volume 8-12ml/kg, respiratory rate 12-16 times per minute. | Procedure: tidal volume<br>* In the volume controlled ventilation group using laryngeal mask airway Guardian,a tidal volume of 8-12ml/kg,respiratory rate12-16bpm.<br>* Other names: TV;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| peak pressure | The end-tidal carbon dioxide, the peak pressure, the mean airway pressure, the compliance were continuously monitored during the procedure and they were recorded at T1:just before carbon dioxide insufflation, T2: 30 minutes after carbon dioxide insufflation and T3: 10 minutes after the withdrawal of carbon dioxide. Data on gas exchange (pH、PaCO2、PaO2 ) at T1、T2 and T3 were recorded by artery blood gas analysis. | 5 min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure | including systolic blood pressure,diastolic blood pressure,mean arterial pressure. | intraoperative | 
| heart rate | heart rate | intraoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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volume controlled ventilation, pressure controlled ventilation