Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201610001791415 Date of Approval: 23/09/2016
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Comparison of I-gel with Baska mask airway for controlled ventilation in obese patients undergoing ambulatory surgery
Official scientific title Comparison of I-gel with Baska mask airway for controlled ventilation in obese patients undergoing ambulatory surgery: A prospective randomized trial
Brief summary describing the background and objectives of the trial Many supra-glottic airway devices (SADs) are currently available for use (1). The I-gel has a non-inflatable cuff made from a gel-like thermoplastic elastomer. It has a semi-rigid stem that acts as stabilizer within the oral cavity. This stabilizer reduces the likelihood of bad positioning, while allowing for rapid, easy, safe, and reliable application (2, 3). The Baska Mask , designed by Australian anesthetists Kanag and Meena Baska, is a new CE-¿approved and internationally patented EAD, provided in single use and multi-use versions (4, 5) . The Baska mask obviates the need for an orogastric tube and replaces this with a sump and two drains (6) .The Baska Mask® presents with a bite block throughout the entire length of the airway tube. The oval-shaped airway tube matches the shape of the mouth and reduces rotation within the pharynx. Aim of the study: The aim of this work is to evaluate the clinical effectiveness of I-Gel compared with the Baska Mask during general anesthesia in obese patients undergoing elective ambulatory surgeries. Evaluating device performance and oropharyngeal sealing pressure (OSP), the ease and speed of insertion, the success rate of insertion, the number of insertions, the hemodynamic responses induced by airway insertion (blood pressure and heart rate), oxygen saturation (SpO2), end-tidal carbon dioxide (EtCO2), and incidence of postoperative complications (e.g., traces of blood on the device, sore throat, hoarseness, and dysphagia).
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied supraglotic air way , Igell ,baska mask
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 16/04/2016
Actual trial start date 16/04/2016
Anticipated date of last follow up 23/09/2016
Actual Last follow-up date 23/09/2016
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised ¿Simple randomisation using a radomisation table created by a computer software program ¿Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group i gel use the i gel mask for ventilatio 30 Active-Treatment of Control Group
Experimental Group baska mask using braska mask for ventilation 30 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
obese patients with BMI ¿ 40 kg.m_2, ASA physical status 1-3, 18-60 years of age of either sex scheduled for short duration(<3 hr) ambulatory surgery. gastrointestinal reflux, sore throat or upper respiratory airway infection with known or suspected difficult airways 18 Year(s) 60 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 27/03/2016 Alexandria university ethical committee
Ethics Committee Address
Street address City Postal code Country
elmasala st Alexandria 03 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome to evaluate the clinical effectiveness of I-Gel compared with the Baska Mask during general anesthesia in obese patients undergoing elective ambulatory surgeries. after insertion of the mask 1 min after insertion of the mask 5 min after insertion of the mask 15 min after insertion of the mask after removal of the mask
Secondary Outcome any complication detected from using the mask at the end of the operation
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
alexandria university elmasala alexandria 03 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
alexandria university elmasala alexandria 03 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor alexandria university elmasala alexandria 03 Egypt University
COLLABORATORS
Name Street address City Postal code Country
dr rehb abd elraouf 33 horya st alexandria 03 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator yasser osman yasseralx@hotmail.com 01006357996 368 horia st
City Postal code Country Position/Affiliation
alexandria 03 Egypt professor
Role Name Email Phone Street address
Public Enquiries ehab mohamed osmanehab@yahoo.com 01006357995 45sydigaber st
City Postal code Country Position/Affiliation
alexandria 03 Egypt professor
Role Name Email Phone Street address
Scientific Enquiries rehab abdelraouf trcium2002@yahoo.com 0103356997 elhedaya st
City Postal code Country Position/Affiliation
alexandria 03 Egypt professor
REPORTING
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URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information