Comparison of Two Ventilation Modes With Laryngeal Mask Airway Guardian

Not Applicable

• Conditions: Gynecologic Disease
• Interventions: Procedure: peak airway pressure; Procedure: tidal volume

• Registration Number: NCT02097628
• Lead Sponsor: Haiyun Wang

Brief Summary

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

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.

Study Timeline

• Status Verified: 2014-03
• Study First Submitted: 2014-03-18
• Study First Submitted QC: 2014-03-26
• Last Update Submitted: 2014-03-26
• Study First Posted: 2014-03-27
• Last Update Posted: 2014-03-27
• Study Start: 2014-04
• Primary Completion: 2014-10
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
pressure-controlled ventilation	peak airway pressure	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.
volume-controlled ventilation	tidal volume	volume-controlled ventilation: tidal volume 8-12ml/kg, respiratory rate 12-16 times per minute.

Primary Outcome Measures

Name	Time	Method
peak pressure	5 min	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.

Secondary Outcome Measures

Name	Time	Method
Blood pressure	intraoperative	including systolic blood pressure,diastolic blood pressure,mean arterial pressure.
heart rate	intraoperative	heart rate