Clinical trial NCT03140215: Comparative Study of Baska & I-gel for Ventilation of Female Patients During Minor Procedures
Official title: Comparative Study of Baska & I-Gel for Spontaneously Ventilated Females During Minor Gynecological Procedures
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Medical Device Complication
Keywords: Baska
seal pressure
I-Gel
Supraglottic airway device
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-05-04
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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

Eligibility criteria: Inclusion Criteria:

* Female ASA1,2
* Age 18-55
* BMI\<35

Exclusion Criteria:

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

Primary outcomes:
measure: seal pressure
timeFrame: seal pressure will be assessed 3minutes after induction of general anesthesia.
Secondary outcomes:
measure: Fiberoptic view of the larynx.
timeFrame: Fiberoptic view will be assessed 5 minutes after induction of anesthesia.
measure: Peak airway pressure in CmH2O
timeFrame: during the operation the operation
measure: incidence of vomiting and regurgitation
timeFrame: from the start of operation till 10 minutes postoperative
Other outcomes:
Locations:
Study officials:
affiliation: Cairo University
name: Nesrine A. El-Refai, M.D
role: PRINCIPAL_INVESTIGATOR
References: