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.: PACTR201908676968471 Date of Approval: 05/08/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title comparison of blind intubation through two supraglottic devices in pediatric patients undergoing lower abdominal surgeries
Official scientific title comparison of blind intubation through two supraglottic devices in pediatric patients undergoing lower abdominal surgeries
Brief summary describing the background and objectives of the trial A RCT aiming to prove efficacy of Air Q vs CLMA in blind intubation in pediatric patients undergoing lower abdominal surgeries, as regard easiness of insertion ,success rate of blind intubation and comparing leakage pressure of positive pressure ventilation
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Devices
Anticipated trial start date 01/01/2019
Actual trial start date 01/01/2019
Anticipated date of last follow up 01/01/2020
Actual Last follow-up date 02/08/2019
Anticipated target sample size (number of participants) 110
Actual target sample size (number of participants) 110
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Air Q intraoperative intraoperative usage of Air Q supraglootic devices to show priveleges IN BLIND INTUBATION 55
Control Group CLMA intraoperative trial o blind intubation using I Gel 55 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
children between 3 to 5 years whom are candidates for lower abdominal surgeries craniofacial anomalies obesity poor general conditiom Preschool Child: 2 Year-5 Year 3 Year(s) 5 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 01/01/2019 ethical committee of faculty of medicine ain shams
Ethics Committee Address
Street address City Postal code Country
38 abbaseya cairo 113811 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Success rate in blind intubation intraoperative affter application
Primary Outcome easiness of application during insertion
Secondary Outcome success after 1st or 2nd trial after application
Secondary Outcome leak pressure difference between the two devices during ventilation wit the device
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
ain shams university abbaseya square cairo 113811 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
gamal adel nasr city cairo 113811 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor gamal adel nasr city cairo 113811 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
ahmed t. abaseya cairo 113811 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator gamal adel gem6082@yahoo.com 00201005006082 nasr city
City Postal code Country Position/Affiliation
egypt 113811 Egypt lecturer of anesthesia
Role Name Email Phone Street address
Scientific Enquiries wael ghanem gem6082@yahoo.com 00201208555520 masr gedida
City Postal code Country Position/Affiliation
cairo 113811 Egypt ass. prof of pediatric surgery
Role Name Email Phone Street address
Public Enquiries simon halim simondr106@gmail.com 00201208555520 abbaseya
City Postal code Country Position/Affiliation
nasr city 113811 Egypt lecturer of anesthesia
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes raw material or summary of our results will be shared in the form of tables or an SPSS sheet Informed Consent Form,Statistical Analysis Plan,Study Protocol IN a 6 month period to year controlled access upon request requested from the primary scientific researcher
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information