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| Name | Class |
|---|---|
| Tianjin Medical University General Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| pressure-controlled ventilation | Active Comparator | 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. |
|
| volume-controlled ventilation | Experimental | volume-controlled ventilation: tidal volume 8-12ml/kg, respiratory rate 12-16 times per minute. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tidal volume | Procedure | In the volume controlled ventilation group using laryngeal mask airway Guardian,a tidal volume of 8-12ml/kg,respiratory rate12-16bpm. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Blood pressure | including systolic blood pressure,diastolic blood pressure,mean arterial pressure. | intraoperative |
| heart rate | heart rate |
| Measure | Description | Time Frame |
|---|---|---|
| Pharyngolaryngeal complication | the presence of either sore throat, dysphonia or dysphagia at 1 and 24 h postoperatively | 1,24h |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Haiyun Wang, M.D., Ph.D | Contact | 13752211206 | wanghy819@hotmail.com | |
| Zhiting Wen, M.D. | Contact | 13682191271 | awen0829@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Haiyun Wang, M.D.Ph.D. | Tianjin Medical University General Hospital | Study Chair |
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| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| ID | Term |
|---|---|
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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| ID | Term |
|---|---|
| D013990 | Tidal Volume |
| ID | Term |
|---|---|
| D007320 | Inspiratory Capacity |
| D014797 | Vital Capacity |
| D014109 | Total Lung Capacity |
| D008176 | Lung Volume Measurements |
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|
| peak airway pressure | 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. |
|
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| intraoperative |
| D012129 |
| Respiratory Function Tests |
| D003948 | Diagnostic Techniques, Respiratory System |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D012143 | Respiratory Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |