Gynecologic Disease
Conditions
Keywords
volume controlled ventilation, pressure controlled ventilation
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.
Interventions
PROCEDUREtidal volume
In the volume controlled ventilation group using laryngeal mask airway Guardian,a tidal volume of 8-12ml/kg,respiratory rate12-16bpm.
PROCEDUREpeak 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.
Sponsors
Tianjin Medical University General Hospital
Haiyun Wang
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| peak pressure | 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
| Measure | Time frame | Description |
|---|---|---|
| Blood pressure | intraoperative | including systolic blood pressure,diastolic blood pressure,mean arterial pressure. |
| heart rate | intraoperative | heart rate |
Other
| Measure | Time frame | Description |
|---|---|---|
| Pharyngolaryngeal complication | 1,24h | the presence of either sore throat, dysphonia or dysphagia at 1 and 24 h postoperatively |
Contacts
Primary ContactHaiyun Wang, M.D., Ph.D
Backup ContactZhiting Wen, M.D.
Outcome results
None listed