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

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.

Study Overview

• Status: Unknown
• Conditions: Medical Device Complication
• Intervention / Treatment: Device: laryngeal mask insertion (Baska); Device: laryngeal mask insertion (I-gel )

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

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Female ASA1,2
• Age 18-55
• BMI<35

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Baska Device ventilation group; Device: laryngeal mask insertion (Baska)	Device: laryngeal mask insertion (Baska); Other Names: Baska; Device: laryngeal mask insertion (I-gel ); Other Names: I-gel
Active Comparator: I-Gel device ventilation group; Device: laryngeal mask insertion ( I-gel )	Device: laryngeal mask insertion (Baska); Other Names: Baska; Device: laryngeal mask insertion (I-gel ); Other Names: I-gel

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Nesrine A. El-Refai, M.D, Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Actual): December 1, 2016
• Study Completion (Anticipated): August 1, 2017

Study Registration Dates

• First Submitted: January 8, 2016
• First Submitted That Met QC Criteria: May 2, 2017
• First Posted (Actual): May 4, 2017

Study Record Updates

• Last Update Posted (Actual): May 4, 2017
• Last Update Submitted That Met QC Criteria: May 2, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Supraglottic airway device; I-Gel; seal pressure; Baska
• Other Study ID Numbers: UTF-8

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED