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The study aimed to compare safety of the 3rd generation Supra-glottic airway device (SAD) "Baska" to the I-Gel , regarding seal pressure, fitting on the larynx (detected by Fiberoptic) & complications. The study will be done for females undergoing minor gynecological procedures under general anesthesia with spontaneous ventilation.
Population of study & disease condition : 2 equal groups (n=30), female patients enrolled for minor gynecological procedures (D&C or hysteroscopy), All patients received general anesthesia with spontaneous ventilation using Supra-glottic airway Device (SAD). Group A (Baska) & group B ( I-gel).
Inclusion Criteria: Age: 18-55, American Society of Anesthesia (ASA) 1 or 2, BMI<35 & Low risk of aspiration.
Exclusion Criteria: Anticipated upper airway problem, Gastrointestinal tract (GIT, disease, pregnancy & High risk of aspiration.
Methodology: All patients received fentanyl 1 micro gram/Kg, Propofol(2-4mg/Kg) was titrated to induce anesthesia, followed by manual ventilation with sevoflurane (2-4%) in Oxygen.All devices were inserted by one of 2 investigators.
Data collection: 1- Demographic Data: age,weight,height.2-duration of anesthesia.3- Data related to device insertion: Time of insertion,duration of anesthesia, seal pressure,peak airway pressure, Fiberoptic (FO)view of the larynx ,vomiting or regurgitation, postoperative laryngeal spasm or blood on the device after removal.
Primary outcome: To detect seal pressure and fitting against laryngeal aperture detected by FO. Secondary outcome:To determine Peak pressure, incidence of complications: vomiting or regurgitation, blood on the device after removal (indicating trauma to the airway) or postoperative laryngeal spasm..
Statistical analysis: For analysis of continuous variables independent sample t-test will be applied and for categorical variables chi-square test will be used.value of p<0.05 will be considered significant.
Sample size:
Sample size was calculated using EpiCalc program using the following data : mean seal pressure for Baska :29.98 , mean seal pressure for I-Gel: 25.62. SD: 4.9
, study power 80% confidence interval . P value<0.05. the calculated sample size was found to be 19 for each group (overall 38), so the investigators will allocate 30 patient in each group to avoid drop out.
Statistical analysis:
Source of funding This study will be attributed to Department of Anesthesiology, Faculty of medicine, Cairo University. Support will be provided solely from departmental sources. Keywords: Baska, I-Gel, Supra-glottic airway devices, seal pressure
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Baska Device ventilation group | Active Comparator | Device: laryngeal mask insertion (Baska) |
|
| I-Gel device ventilation group | Active Comparator | Device: laryngeal mask insertion ( I-gel ) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| laryngeal mask insertion (Baska) | Device |
|
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| Measure | Description | Time Frame |
|---|---|---|
| seal pressure | Airway Sealing Pressure in cmH2O at 5 mins postplacement.The airway sealing pressure was the pressure at which leak starts. This leak pressure was calculated as the plateau airway pressure reached with fresh gas flow 6 l/min, and pressure adjustment valve set at 70 cmH2O.. | seal pressure will be assessed 3minutes after induction of general anesthesia. |
| Measure | Description | Time Frame |
|---|---|---|
| Fiberoptic view of the larynx. | The fiberoptic device will be introduced through the device to visualize & record the view | Fiberoptic view will be assessed 5 minutes after induction of anesthesia. |
| Peak airway pressure in CmH2O |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nesrine A. El-Refai, M.D | Cairo University | Principal Investigator |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Sep 25, 2017 | |
| Reset | Oct 23, 2017 | |
| Release | Oct 30, 2017 | |
| Unrelease | Yes |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Sep 25, 2017 | Oct 23, 2017 | |||
| Oct 30, 2017 |
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| laryngeal mask insertion (I-gel ) | Device |
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The peak airway pressure will be monitored during the operation time
| during the operation the operation |
| incidence of vomiting and regurgitation | patients will be monitored to detect vomiting & regurgitation. | from the start of operation till 10 minutes postoperative |
| Yes |