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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
60
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..
Time frame: seal pressure will be assessed 3minutes after induction of general anesthesia.
Fiberoptic view of the larynx.
The fiberoptic device will be introduced through the device to visualize \& record the view
Time frame: 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
Time frame: during the operation the operation
incidence of vomiting and regurgitation
patients will be monitored to detect vomiting \& regurgitation.
Time frame: from the start of operation till 10 minutes postoperative
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