Comparative Study of Baska & I-gel for Ventilation of Female Patients During Minor Procedures
NCT ID: NCT03140215
Last Updated: 2017-05-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2016-06-30
2017-08-31
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Baska Device ventilation group
Device: laryngeal mask insertion (Baska)
laryngeal mask insertion (Baska)
laryngeal mask insertion (I-gel )
I-Gel device ventilation group
Device: laryngeal mask insertion ( I-gel )
laryngeal mask insertion (Baska)
laryngeal mask insertion (I-gel )
Interventions
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laryngeal mask insertion (Baska)
laryngeal mask insertion (I-gel )
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age 18-55
* BMI\<35
Exclusion Criteria
* GIT disease
* Pregnancy
* High risk of aspiration
18 Years
55 Years
FEMALE
No
Sponsors
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Cairo University
OTHER
Responsible Party
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Nesrine El-Refai
professor
Principal Investigators
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Nesrine A. El-Refai, M.D
Role: PRINCIPAL_INVESTIGATOR
Cairo University
Other Identifiers
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UTF-8
Identifier Type: -
Identifier Source: org_study_id
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