Comparison of Two Ventilation Modes With Laryngeal Mask Airway Guardian

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2014-12-31

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.

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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.

Conditions

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Gynecologic Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

peak airway pressure

Intervention Type PROCEDURE

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.

volume-controlled ventilation

volume-controlled ventilation: tidal volume 8-12ml/kg, respiratory rate 12-16 times per minute.

Group Type EXPERIMENTAL

tidal volume

Intervention Type PROCEDURE

In the volume controlled ventilation group using laryngeal mask airway Guardian,a tidal volume of 8-12ml/kg,respiratory rate12-16bpm.

Interventions

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tidal volume

In the volume controlled ventilation group using laryngeal mask airway Guardian,a tidal volume of 8-12ml/kg,respiratory rate12-16bpm.

Intervention Type 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.

Intervention Type PROCEDURE

Other Intervention Names

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TV airway peal pressure peak pressure of aieway

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No