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| ID | Type | Description | Link |
|---|---|---|---|
| HUSE 012-ANR-2017 | Other Identifier | Hospital Universitario del Sureste |
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To compare the effects of i-gel and Ambu AuraGain on ventilation parameters and surgical view during Trendelenburg position laparoscopic gynecological surgery in cases administered positive pressure ventilation without the use of neuromuscular agents.
Prospective, multicenter, randomized and double-blind study, aged from 18 to 65 years undergoing elective laparoscopic gynecological surgery.
The patients are randomly assigned to 2 groups:
Group i-gel Group Ambu AuraGain
Procedure:
The investigation protocol contains the following sections:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group i-gel | Active Comparator | Insertion of the airway device. The size of the airway device used is based on the manufacturers' recommendations and evaluation of its clinical performance |
|
| Group Ambu Auragain | Experimental | Insertion of the airway device. The size of the airway device used is based on the manufacturers' recommendations and evaluation of its clinical performance |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| i-gel | Device | Evaluation of clinical performance in terms of insertion, ventilation and complications |
|
| Measure | Description | Time Frame |
|---|---|---|
| Insertion time | The time taken to successfully place the device in seconds | intraoperative |
| Change in airway seal pressure | The maximum oropharyngeal leak pressure attained for each device. | intraoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Number of attempts at insertion | The number of repeated attempts required for successfully placing the device. Each device was given a chance of 3 attempts if still unsuccessful after 3 attempts another device was placed. | intraoperative |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sule Ozbilgin, MD | Dokuz Eylul University, School of Medicine, Department of Anesthesiology and Intensive Care | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sureste University Hospital, Department of Anesthesiology and Critical Care | Madrid | Spain | ||||
| Dokuz Eylul University, School of Medicine, Department of Anesthesiology and Intensive Care |
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Prospective, multicenter, randomized
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| Ambu AuroGain | Device | Evaluation of clinical performance in terms of insertion, ventilation and complications |
|
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| Izmir |
| Turkey (Türkiye) |