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

Not Applicable

• Conditions: Medical Device Complication
• Interventions: Device: laryngeal mask insertion (Baska); Device: laryngeal mask insertion (I-gel )

• Registration Number: NCT03140215
• Lead Sponsor: Cairo University

Brief 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

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2016-01-08
• Study Start: 2016-06
• Primary Completion: 2016-12
• Status Verified: 2017-05
• Study First Submitted QC: 2017-05-02
• Last Update Submitted: 2017-05-02
• Study First Posted: 2017-05-04
• Last Update Posted: 2017-05-04
• Study Completion: 2017-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

• Female ASA1,2
• Age 18-55
• BMI<35

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Exclusion Criteria

• Anticipated upper airway problem
• GIT disease
• Pregnancy
• High risk of aspiration

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Baska Device ventilation group	laryngeal mask insertion (I-gel )	Device: laryngeal mask insertion (Baska)
Baska Device ventilation group	laryngeal mask insertion (Baska)	Device: laryngeal mask insertion (Baska)
I-Gel device ventilation group	laryngeal mask insertion (Baska)	Device: laryngeal mask insertion ( I-gel )
I-Gel device ventilation group	laryngeal mask insertion (I-gel )	Device: laryngeal mask insertion ( I-gel )

Primary Outcome Measures

Name	Time	Method
seal pressure	seal pressure will be assessed 3minutes after induction of general anesthesia.	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..

Secondary Outcome Measures

Name	Time	Method
incidence of vomiting and regurgitation	from the start of operation till 10 minutes postoperative	patients will be monitored to detect vomiting \& regurgitation.
Fiberoptic view of the larynx.	Fiberoptic view will be assessed 5 minutes after induction of anesthesia.	The fiberoptic device will be introduced through the device to visualize \& record the view
Peak airway pressure in CmH2O	during the operation the operation	The peak airway pressure will be monitored during the operation time