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To compare the effects of i-gel and Laryngeal mask airway Supreme (LMA-Supreme) 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, randomized and double-blind study, aged from 18 to 65 years undergoing elective laparoscopic gynecological surgery.
The patients are randomly assigned to 2 groups:
Procedure:
The investigation protocol contains the following sections:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laryngeal mask Supreme | Active Comparator | Insertion of the "Laryngeal mask Supreme" and evaluation of its clinical performance |
|
| i-gel | Experimental | Insertion of the "i-gel" and evaluation of its clinical performance |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laryngeal mask Supreme Evaluation | Device | Evaluation of clinical performance in terms of Insertion, ventilation and complications |
|
| Measure | Description | Time Frame |
|---|---|---|
| Airway Seal Pressure Values | This value is important as it indicates the feasibility of positive pressure ventilation and the degree of airway protection from supracuff soiling. It is also used in LMA studies as an index of successful placement.Airway pressures of ≈20 cm H2O are typically required in routine practice. | At baseline and at 15, 30 and 60 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Quality | quality of surgical view will evaluate by the scala. quality of surgical view will be assessed with points from 1 to 4 by the surgeon blind to the airway device; (1:best, 4: worst). | during pneumoperitoneum |
| Gastric Tube Insertion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ferim Günenç, MD | Dokuz Eylül University, School of Medicine, Department of Anesthesiology and Reanimation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dokuz Eylül University, School of Medicine, Department of Anesthesiology and Reanimation | Izmir | 35340 | Turkey (Türkiye) |
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| ID | Title | Description |
|---|---|---|
| FG000 | Laryngeal Mask Supreme | Insertion of the "Laryngeal mask Supreme" and evaluation of its clinical performance Laryngeal mask Supreme Evaluation: Evaluation of clinical performance in terms of Insertion, ventilation and complications |
| FG001 | I-gel | Insertion of the "i-gel" and evaluation of its clinical performance i-gel Evaluation: Evaluation of clinical performance in terms of Insertion,ventilation and complications |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Laryngeal Mask Supreme | Insertion of the "Laryngeal mask Supreme" and evaluation of its clinical performance Laryngeal mask Supreme Evaluation: Evaluation of clinical performance in terms of Insertion, ventilation and complications |
| BG001 | I-gel |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Airway Seal Pressure Values | This value is important as it indicates the feasibility of positive pressure ventilation and the degree of airway protection from supracuff soiling. It is also used in LMA studies as an index of successful placement.Airway pressures of ≈20 cm H2O are typically required in routine practice. | Posted | Mean | Standard Deviation | cm H2O | At baseline and at 15, 30 and 60 minutes |
|
24 hour
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Laryngeal Mask Supreme | Insertion of the "Laryngeal mask Supreme" and evaluation of its clinical performance Laryngeal mask Supreme Evaluation: Evaluation of clinical performance in terms of Insertion, ventilation and complications |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anaesthesiology and Intensive Care, Sule Ozbilgin | DorkuzEU | 905055252901 | ozbilginsule@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 21, 2017 | Sep 12, 2020 | Prot_SAP_000.pdf |
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| i-gel Evaluation | Device | Evaluation of clinical performance in terms of Insertion,ventilation and complications |
|
Number of Participants According to Ease of Gastric Tube Insertion.Ease of passage of a gastric tube as: very easy, easy, difficult or very difficult.
| following airway device insertion up to 5 minutes |
| Postoperative Pharyngolaryngeal Morbidity | Sore throat evaluted by Visual Analogue Scale. The visual analog scale, also known as the graphic rating scale is a simple, valid and reliable subjective measure. Scores are ranked on a 10-cm line that stretches between two extremes - "no pain" and "worst pain". Total range provided"0 (no pain) to 10 (worst pain). | postoperative first hour and 24th hour |
| Sufficiency of Pneumoperitoneum | Number of Participants with Sufficiency of Pneumoperitoneum. Sufficiency of pneumoperitoneum for the surgical procedure according to surgeon, described as sufficient or insufficient questionaire. | baseline |
| Mean Airway Pressure Values | Mean airway pressure typically refers to the mean pressure applied during positive-pressure mechanical ventilation. Mean airway pressure correlates with alveolar ventilation, arterial oxygenation, hemodynamic performance, and barotrauma. | At baseline and at 15, 30 and 60 minutes |
| Dysphonia With Yes/no. | We evaluated while a patient was talking with us that the patient has dysphonia or not . | postoperative first hour and 24th hour |
| Disphagia | We asked the question that you have a pain while you were swallowing, yes or not. | postoperative first hour and 24th hour |
| can not replace LMA |
|
Insertion of the "i-gel" and evaluation of its clinical performance i-gel Evaluation: Evaluation of clinical performance in terms of Insertion,ventilation and complications |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
| Secondary | Visual Quality | quality of surgical view will evaluate by the scala. quality of surgical view will be assessed with points from 1 to 4 by the surgeon blind to the airway device; (1:best, 4: worst). | Posted | Mean | Standard Deviation | units on a scale | during pneumoperitoneum |
|
|
|
| Secondary | Gastric Tube Insertion | Number of Participants According to Ease of Gastric Tube Insertion.Ease of passage of a gastric tube as: very easy, easy, difficult or very difficult. | Posted | Number | participants | following airway device insertion up to 5 minutes |
|
|
|
| Secondary | Postoperative Pharyngolaryngeal Morbidity | Sore throat evaluted by Visual Analogue Scale. The visual analog scale, also known as the graphic rating scale is a simple, valid and reliable subjective measure. Scores are ranked on a 10-cm line that stretches between two extremes - "no pain" and "worst pain". Total range provided"0 (no pain) to 10 (worst pain). | Posted | Mean | Standard Deviation | units on a scale | postoperative first hour and 24th hour |
|
|
|
| Secondary | Sufficiency of Pneumoperitoneum | Number of Participants with Sufficiency of Pneumoperitoneum. Sufficiency of pneumoperitoneum for the surgical procedure according to surgeon, described as sufficient or insufficient questionaire. | Posted | Count of Participants | Participants | baseline |
|
|
|
| Secondary | Mean Airway Pressure Values | Mean airway pressure typically refers to the mean pressure applied during positive-pressure mechanical ventilation. Mean airway pressure correlates with alveolar ventilation, arterial oxygenation, hemodynamic performance, and barotrauma. | Posted | Mean | Standard Deviation | cm H2O | At baseline and at 15, 30 and 60 minutes |
|
|
|
| Secondary | Dysphonia With Yes/no. | We evaluated while a patient was talking with us that the patient has dysphonia or not . | Posted | Number | Number of Participants without Dysphonia | postoperative first hour and 24th hour |
|
|
|
| Secondary | Disphagia | We asked the question that you have a pain while you were swallowing, yes or not. | Posted | Count of Participants | Participants | postoperative first hour and 24th hour |
|
|
|
| 0 |
| 51 |
| 0 |
| 51 |
| 0 |
| 51 |
| EG001 | I-gel | Insertion of the "i-gel" and evaluation of its clinical performance i-gel Evaluation: Evaluation of clinical performance in terms of Insertion,ventilation and complications | 0 | 55 | 0 | 55 | 0 | 55 |
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| difficult |
|
| very difficult |
|
| at 30 min |
|
| at 60 min |
|