Comparison of Two Ventilation Modes With Laryngeal Mask Airway Guardian (wang002)

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

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.

Study Overview

• Status: Unknown
• Conditions: Gynecologic Disease
• Intervention / Treatment: Procedure: peak airway pressure; Procedure: tidal volume

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 Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: pressure-controlled ventilation; 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; 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.; Other Names: airway peal pressure; peak pressure of aieway
Experimental: volume-controlled ventilation; volume-controlled ventilation: tidal volume 8-12ml/kg, respiratory rate 12-16 times per minute.	Procedure: tidal volume; In the volume controlled ventilation group using laryngeal mask airway Guardian,a tidal volume of 8-12ml/kg,respiratory rate12-16bpm.; Other Names: TV

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharyngolaryngeal complication	the presence of either sore throat, dysphonia or dysphagia at 1 and 24 h postoperatively	1,24h

Collaborators and Investigators

• Sponsor: Haiyun Wang
• Collaborators: Tianjin Medical University General Hospital
• Investigators: Study Chair: Haiyun Wang, M.D.Ph.D., Tianjin Medical University General Hospital

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Anticipated): October 1, 2014
• Study Completion (Anticipated): December 1, 2014

Study Registration Dates

• First Submitted: March 18, 2014
• First Submitted That Met QC Criteria: March 26, 2014
• First Posted (Estimate): March 27, 2014

Study Record Updates

• Last Update Posted (Estimate): March 27, 2014
• Last Update Submitted That Met QC Criteria: March 26, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Keywords: volume controlled ventilation; pressure controlled ventilation
• Other Study ID Numbers: wang002