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.: PACTR201611001844266 Date of Approval: 01/11/2016
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Efficacy of non inflatable cuff ( i-gel, SLIPA) versus inflatable cuff (Soft Seal LMA) supraglottic airways in paralyzed adult patients. Comparative study
Official scientific title Efficacy of non inflatable cuff ( i-gel, SLIPA) versus inflatable cuff (Soft Seal LMA) supraglottic airways in paralyzed adult patients. Comparative study.
Brief summary describing the background and objectives of the trial this stdy aims to compare the efficacy of non-inflatable cuff supraglottic airways (i-gel and SLIPA) to inflatable cuff soft seal LMA (SSLMA) in patients requiring general anesthesia and controlled ventilation during elective surgical procedures.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied patients taking general anestheia,Respiratory
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Devices
Anticipated trial start date 01/11/2016
Actual trial start date 01/11/2016
Anticipated date of last follow up 01/12/2016
Actual Last follow-up date 01/11/2016
Anticipated target sample size (number of participants) 120
Actual target sample size (number of participants) 120
Recruitment status Recruiting
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 computer-generated randomization sequence 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 group The i-gel was grasped along the integral bite block and was introduced into the mouth towards the hard palate until resistance was felt. 40 Active-Treatment of Control Group
Experimental Group SLIPA group The SLIPATM was introduced into the pharynx. The SSLMA was introduced with the cuff partially inflated till a definite resistance was felt as the tip entered the hypopharynx. The cuff was inflated to a ¿just seal¿ pressure, defined as no leak on gentle manual ventilation. If substantial leakage occurred despite optimal placement of the SSLMA another 10 ml of air was added. Then the SGA was secured 40
Experimental Group soft seal LMA (SSLMA) The SSLMA was introduced with the cuff partially inflated till a definite resistance was felt as the tip entered the hypopharynx. The cuff was inflated to a ¿just seal¿ pressure, defined as no leak on gentle manual ventilation. If substantial leakage occurred despite optimal placement of the SSLMA another 10 ml of air was added. 40
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
120 patients scheduled for elective general surgery . Only patients classified as ASA I and II were eligible for inclusion. high risk for pulmonary aspiration: diabetic, obese and pregnant women. Patients having lung disease, difficult airway, surgery performed in non supine position, oral or nasal surgery and preoperative sore throat were also excluded. 20 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 18/10/2016 Tanta Univercity, Faculty of Medicine, Research Ethics Committee, Quality Assurance Unit
Ethics Committee Address
Street address City Postal code Country
Elbahr Street Tanta Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome tidal volume , End tidal CO2 and leak pressure during ventillation
Secondary Outcome Gastric air insufflations (%) afterinsertion
Secondary Outcome Blood traces on airway device (%) afterinsertion
Secondary Outcome Incidence of sore throat (%) after operation
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tanta Univercity Hospital Elbahr Street Tanta Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Tanta Univercity hospital anaesthesia department Elbahr Street Tanta Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Tanta Univercity hospital anaesthesia department Elbahr Street Tanta Egypt University
COLLABORATORS
Name Street address City Postal code Country
Mona Mohammed Mogahed Elmoatasem Street Tanta Egypt
Attia Gad Anwar Hassan Radwan St Tanta Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Attia Anwar atteiagad@gmail.com 01273693928 Hasan Radwan St
City Postal code Country Position/Affiliation
Tanta Egypt Lecturer of anesthesia and surgical Intensive care Faculty of medicine Tanta University
Role Name Email Phone Street address
Public Enquiries Atteia Anwar atteiagad@gmail.com 0201273693928 Hasan Radwan St
City Postal code Country Position/Affiliation
Tanta Egypt lecturer of anesthesiology and ICU
Role Name Email Phone Street address
Scientific Enquiries Mona Mogahed monamogahedfr@hotmail.com 00201145130150 Elmoatasem
City Postal code Country Position/Affiliation
Tanta Egypt Lecturer of anesthesia and surgical Intensive care Faculty of medicine Tanta University
REPORTING
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information