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.: PACTR201701001985265 Date of Approval: 18/01/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Evaluation of head and neck position on oropharyngeal leak pressure with baska mask and streamlined liner of pharyngeal airway (SLIPATM): a randomize
Official scientific title Evaluation of head and neck position on oropharyngeal leak pressure with baska mask and streamlined liner of pharyngeal airway (SLIPATM): a randomized clinical trial
Brief summary describing the background and objectives of the trial Supraglottic airway devices (SGA) have been widely used as an alternative to tracheal intubation during general anesthesia.(1) The streamlined liner of the pharynx airway (SLIPATM) is a non-cuffed single-use, latex-free SGA, with an anatomically performed shape which sticks to the pharynx and palate. (2, 3) The body of SLIPA is shaped like a hollow boot with ¿toe,¿ ¿bridge,¿ and ¿heel¿ prominences, which is engaged in the patient¿s pharynx, allowing it to seal without the use of an inflatable cuff. It therefore does not require cuff inflation and extra straps to maintain a secure airway during positive pressure ventilation. Furthermore, a 50-ml empty internal space allows the removal of pharyngeal secretions, thus reducing the risk of pulmonary aspiration. (2, 4) 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 (5, 6). The Baska mask obviates the need for an orogastric tube and replaces this with a sump and two drains (7) .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. Due to changes in the shape of the pharynx during head and neck movement, there is a possibility of changes in the force transmitted along the airway device during ventilation. (8) Aim of the study: The primary objective of this study is to compare the oropharyngeal leak pressures of streamlined liner of pharyngeal airway (SLIPATM) and the Baska mask at different head and neck positions, namely, neutral, flexion, extension, and left rotation. Also to assess and compare the fiberoptic view of glottis, ventilator score and incidence of complication of both devices in different head and neck positions (secondary objectives).
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied supraglotic devices ,baska mask ,slipa
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Supportive care
Anticipated trial start date 05/12/2016
Actual trial start date 12/12/2016
Anticipated date of last follow up 01/03/2017
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
Recruitment status Recruiting
Publication URL Alexandria university
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 Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group baska mask using baska mask for ventilation 30
Experimental Group slipa using slipa mask for ventilation 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
ASA physical status I-II, 18-60 years of age either sex scheduled for short duration(<3 hr) ambulatory surgery. Patients at risk of aspiration, any pathology of the neck, anticipated difficult airway, body mass index ¿ 30 kg/m2, history of obstructive sleep apnea, upper respiratory tract infection, potentially full stomach, having a history of gastro-esophageal reflux 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 14/10/2016 alexandria university ethical committee
Ethics Committee Address
Street address City Postal code Country
elmesala squar Alexandria 03 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome compare the oropharyngeal leak pressures of streamlined liner of pharyngeal airway (SLIPATM) and the Baska mask at different head and neck positions neutral, flexion, extension, and left rotation
Secondary Outcome assess and compare the fiberoptic view of glottis, ventilator score and incidence of complication of both devices in different head and neck positions neutral, flexion, extension, and left rotation
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
alexandria university elmasala square Alexandria 03 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Alexandria university elmasala square Alexandria 03 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Alexandria university elmasala square Alexandria 03 Egypt University
COLLABORATORS
Name Street address City Postal code Country
yasser mohamed osman 168 ahmad shawky st roshdy Alexandria 03 Egypt
rehab abd el raof 233 sydygaber Alexandria 03 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator yasser mohamed yasseralx@hotmail.com +201006357996 186 ahmed shawky
City Postal code Country Position/Affiliation
Alexandria 03 Egypt lecturer in alexandria university
Role Name Email Phone Street address
Public Enquiries yasser mohamed yasseralx@hotmail.com +201006357996 186 ahmed shawky
City Postal code Country Position/Affiliation
Alexandria 03 Egypt lecturer in alexandria university
Role Name Email Phone Street address
Scientific Enquiries yasser osman yasseralx@hotmail.com +201006357996 186 ahmed shawky
City Postal code Country Position/Affiliation
Alexandria 03 Egypt lecturer in alexandria university
REPORTING
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