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Clinical Trials/NCT02097628
NCT02097628
Unknown
Not Applicable

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

Haiyun Wang0 sites40 target enrollmentApril 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Gynecologic Disease
Sponsor
Haiyun Wang
Enrollment
40
Primary Endpoint
peak pressure
Last Updated
12 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 2014
End Date
December 2014
Last Updated
12 years ago
Study Type
Interventional
Study Design
Crossover
Sex
Female

Investigators

Sponsor
Haiyun Wang
Responsible Party
Sponsor Investigator
Principal Investigator

Haiyun Wang

M.D., Ph.D.

Tianjin Medical University General Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

peak pressure

Time Frame: 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 Outcomes

  • Blood pressure(intraoperative)
  • heart rate(intraoperative)

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