Comparison of Two Ventilation Modes With Laryngeal Mask Airway Guardian

Gynecologic Disease Clinical Trial

— wang002  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02097628
• Other study ID #: wang002
• Status: Not yet recruiting
• Phase: N/A
• First received: March 18, 2014
• Last updated: March 26, 2014
• Start date: April 2014
• Est. completion date: December 2014

Study information

• Verified date: March 2014
• Source: Tianjin Medical University General Hospital
• Contact: Haiyun Wang, M.D., Ph.D
• Phone: 13752211206
• Email: wanghy819[@]hotmail.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: December 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Genital Diseases, Female
• Gynecologic Disease

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Haiyun Wang	Tianjin Medical University General Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pharyngolaryngeal complication	the presence of either sore throat, dysphonia or dysphagia at 1 and 24 h postoperatively	1,24h	Yes
Primary	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	Yes
Secondary	Blood pressure	including systolic blood pressure,diastolic blood pressure,mean arterial pressure.	intraoperative	No
Secondary	heart rate	heart rate	intraoperative	No