A Study Comparing the Supraglottic Airway Devices and Endotracheal Tube During Controlled Ventilation for Laparoscopic Surgery

Study Overview
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Brief Summary
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In our study, we compared the ventilation performance of i-gel to the endotracheal tube during laparoscopic surgery. The lungs were ventilated at tidal volumes (8mL/kg) using volume controlled. After that, we wanted to observe the respiratory parameters, such as leak fraction, leak volume, tidal volume, peak airway pressure and mean airway pressure. In our hypothesis, the i-gel may be used reasonable alternative to tracheal tube during volume controlled ventilation in laparoscopic surgeries.

Detailed Description
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In our study, we compared the ventilation performance of i-gel to the endotracheal tube during laparoscopic surgery. Our patient receive i-gel or endotracheal tube by draw. These patients were Included by the criteria:1.ASA I-II2.Age from 20-80 years old, who were underwent elective GYN laparoscopic surgery and had ability to give inform consent. The excluding criteria was: 1.presence of any significant lung, heart, brain disease 2. pathology of the neck or upper respiratory tract 3.Potential difficult intubation 4.an increased risk of aspiration, ex:gastroesophageal reflux, full stomach,Obese (BMI>30), and pregnant woman, who were confirmed by patient history and medical chart. Preoxygenation was maintained for three minutes to avoid bag and mask ventilation. Anesthesia was induced with the routine medication, such as lidocaine、 propofol, fentanyl and cisatracurium. The i-gel or endotracheal tubes were inserted. The lungs were ventilated at the tidal volume (8mL/kg) using volume controlled. After that, we wanted to observe the respiratory parameters, such as leak fraction, leak volume, tidal volume, peak airway pressure and mean airway pressure. In our hypothesis, the i-gel may be used reasonable alternative to tracheal tube during volume controlled ventilation in laparoscopic surgeries.

Official Title
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A Study Comparing the Supraglottic Airway Devices and Endotracheal Tube During Controlled Ventilation for Laparoscopic Surgery

Conditions
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The Comparison of the I-gel and Endotracheal Tube About in Different Ventilation Settings During Laparoscopic Surgery

Intervention / Treatment
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* Device: i-gel
* Device: endotracheal tube
* Drug: lidocaine, propofol, fentanyl and cisatracurium


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA I-II2.Age from 20-80 years old, who were underwent elective GYN laparoscopic surgery and had ability to give inform consent. Exclusion Criteria: presence of any significant lung, heart, brain disease pathology of the neck or upper respiratory tract Potential difficult intubation an increased risk of aspiration, ex:gastroesophageal reflux, full stomach, Obese (BMI>30), pregnant woman, who were confirmed by patient history and medical chart

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 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

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: i-gel, an brand of supraglottic airway device<br>a supraglottic airway devices with a gastric suction channel | Device: i-gel<br>* a supraglottic airway devices without cuff and the material was Styrene Ethylene Butadiene Styrene. gastric channel to the The gastric suction channel can facilitate venting and reduce the aspiration.<br>Drug: lidocaine, propofol, fentanyl and cisatracurium<br> <br> |
| Experimental: endotracheal tube<br>traditional use for protect airway during the surgery | Device: endotracheal tube<br>* traditional and regularly use in many surgeries for maintaining the airway.<br>Drug: lidocaine, propofol, fentanyl and cisatracurium<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| leak fraction | (inspiratory volume-expiratory volume)/inspiratory volume | intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| leak volume | inspiratory volume-expiratory volume | intraoperative |