NCT03140215

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Cairo University · Academic / Other
• Sex: Female
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

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

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

Conditions

• Medical Device Complication

Interventions

Type	Name	Description
DEVICE	laryngeal mask insertion (Baska)
DEVICE	laryngeal mask insertion (I-gel )

Timeline

• Start date: 2016-06-01
• Primary completion: 2016-12-01
• Completion: 2017-08-01
• First posted: 2017-05-04
• Last updated: 2017-05-04