Comparative Study of Baska & I-gel for Ventilation of Female Patients During Minor Procedures

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Comparative Study of Baska & I-Gel for Spontaneously Ventilated Females During Minor Gynecological Procedures

Conditions
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Medical Device Complication

Intervention / Treatment
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* Device: laryngeal mask insertion (Baska)
* Device: laryngeal mask insertion (I-gel )


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female ASA1,2 Age 18-55 BMI<35 Exclusion Criteria: Anticipated upper airway problem GIT disease Pregnancy High risk of aspiration

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Baska Device ventilation group<br>Device: laryngeal mask insertion (Baska) | Device: laryngeal mask insertion (Baska)<br> <br> * Other names: Baska;Device: laryngeal mask insertion (I-gel )<br> <br> * Other names: I-gel;|
| Active Comparator: I-Gel device ventilation group<br>Device: laryngeal mask insertion ( I-gel ) | Device: laryngeal mask insertion (Baska)<br> <br> * Other names: Baska;Device: laryngeal mask insertion (I-gel )<br> <br> * Other names: I-gel;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Baska, seal pressure, I-Gel, Supraglottic airway device