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

Cairo University (CU)

Status: Unknown

Conditions: Medical Device Complication

Treatments: Device: laryngeal mask insertion (I-gel ); Device: laryngeal mask insertion (Baska)

Study type: Interventional

Funder types: Other

Identifiers

NCT03140215

UTF-8

Details and patient eligibility

About

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.

Full 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

Enrollment: 60 patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Female ASA1,2
• Age 18-55
• BMI<35

Exclusion criteria

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Baska Device ventilation group

Active Comparator group

Description:

Device: laryngeal mask insertion (Baska)

Treatment:

Device: laryngeal mask insertion (Baska)

Device: laryngeal mask insertion (I-gel )

I-Gel device ventilation group

Active Comparator group

Description:

Device: laryngeal mask insertion ( I-gel )

Treatment:

Device: laryngeal mask insertion (Baska)

Device: laryngeal mask insertion (I-gel )