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

Haiyun Wang

Status: Unknown

Conditions: Gynecologic Disease

Treatments: Procedure: tidal volume; Procedure: peak airway pressure

Study type: Interventional

Funder types: Other

Identifiers

NCT02097628

wang002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

40 participants in 2 patient groups

pressure-controlled ventilation

Active Comparator group

Description:

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.

Treatment:

Procedure: peak airway pressure

volume-controlled ventilation

Experimental group

Description:

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

Treatment:

Procedure: tidal volume