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.: PACTR201702001718176 Date of Approval: 20/07/2016
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Comparison between I gel, ProSeal and Classical Laryngeal Mask Airways in Paediatrics: randomised controlled trial
Official scientific title Comparison between I gel, ProSeal and Classical Laryngeal Mask Airways in Paediatrics: randomised controlled trial
Brief summary describing the background and objectives of the trial Management of the paediatric airway can be challanging. Many supraglottic devices are now used in paediatrics. However, literature is not consistant on which device offers the best efficacy and least complications. As a university hospital providing anaesthesia to a wide population, we wanted to select a single device to use routinely in our hospital. We conducted this study to compare the most popular airway devices used in paediatrics to find the most appropriate choice.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Airway management,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Devices
Anticipated trial start date 01/01/2015
Actual trial start date 08/01/2015
Anticipated date of last follow up 30/05/2015
Actual Last follow-up date 29/01/2015
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
Research ethical commitee of the Faculty of medicine Fayoum University
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 Online randomization program (http://www.randomizer.org/) Sealed opaque envelopes Open-label(Masking Not Used)
Parallel: different groups receive different interventions at same time during study Randomised Online randomization program (http://www.randomizer.org/) Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Classic laryngeal mask airway group (cLMA) duration of surgery insertion of (cLMA) after induction of anaesthesia 20
Experimental Group I-GEL laryngeal mask airway group (I-GEL) duration of surgery insertion of (I-GEL) after induction of anaesthesia 20
Experimental Group Proseal laryngeal mask airway group (PLMA) duration of surgery insertion of (PLMA) after induction of anaesthesia 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
ASA physical status I and II patients. Undergoing elective surgery (30-90 min) duration, in supine position. In the period between January 2015 and June 2015. Age range between 5to 15 years. Patients with Syndromes known to have difficult airway. Patients with gross upper airway pathology or anatomical anomaly. Patients at risk of aspiration. History of lung diseases 5 Year(s) 15 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 25/03/2014 Research ethical commitee of the Faculty of Medicine Fayoum University
Ethics Committee Address
Street address City Postal code Country
Kiman Fares District Fayoum Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Sucessful management of the airway measured from the moment the facemask was removed until confirmation of successful airway management by capnography.
Secondary Outcome the time to successful insertion was measured from the moment the facemask was removed until the first capnography upstroke after insertion of the device. maximum 3 trials are permitted
Secondary Outcome ease of insertion measured from the moment the facemask was removed until confirmation by capnography.
Secondary Outcome Fiberoptic view After securing the device
Secondary Outcome Oropharyngeal leak pressure after successful airway management
Secondary Outcome Peak airway pressure during early post induction ¿ middle of surgery and directly before emergence
Secondary Outcome Complications intra-operative and post-operative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Fayoum University Hospital Kiman Fares disrtict, El gamaah Fayoum Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Fayoum University Hospital Kiman Fares disrtict, El gamaah Fayoum Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Fayoum University Hospital Kiman Fares disrtict, El gamaah Fayoum Egypt University
COLLABORATORS
Name Street address City Postal code Country
Manal Elgohary Faculty of Medicin, Cairo University Cairo Egypt
Joseph Makram Botros 105 Toman Bai street, Zeitoun Cairo 11312 Egypt
Engy Samuel 57 seen, Hadayek Alahram Giza Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Engy Samuel engysamuel@gmail.com 001004731345 57 seen, Hafayek Alahram
City Postal code Country Position/Affiliation
Giza Egypt
Role Name Email Phone Street address
Principal Investigator Joseph Botros dr_jo27@yahoo.com 00201227598825 105 Toman Bai Street, Zeitoun
City Postal code Country Position/Affiliation
Cairo 11312 Egypt
Role Name Email Phone Street address
Public Enquiries Joseph Botros dr_jo27@yahoo.com 00201227598825 105 Toman Bai Street, Zeitoun
City Postal code Country Position/Affiliation
Cairo 11312 Egypt
Role Name Email Phone Street address
Scientific Enquiries Engy Samuel engysamuel@gmail.com 001004731345 57 seen, Hafayek Alahram
City Postal code Country Position/Affiliation
Giza Egypt
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
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