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

Medical Device Complication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03140215
• Other study ID #: UTF-8
• Status: Active, not recruiting
• Phase: N/A
• First received: January 8, 2016
• Last updated: May 2, 2017
• Start date: June 2016
• Est. completion date: August 2017

Study information

• Verified date: May 2017
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: August 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Female ASA1,2

• Age 18-55

• BMI<35

Exclusion Criteria:

• Anticipated upper airway problem

• GIT disease

• Pregnancy

• High risk of aspiration

Related Conditions & MeSH terms

• Medical Device Complication

Intervention

Device:
• laryngeal mask insertion (Baska)

• laryngeal mask insertion (I-gel )

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	Peak airway pressure in CmH2O	The peak airway pressure will be monitored during the operation time	during the operation the operation
Secondary	incidence of vomiting and regurgitation	patients will be monitored to detect vomiting & regurgitation.	from the start of operation till 10 minutes postoperative