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.: PACTR201704002105415 Date of Approval: 15/03/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title The use of the classic laryngeal mask airway versus endotracheal tube in children undergoing elective surgeries in the prone position
Official scientific title The use of the classic laryngeal mask airway versus endotracheal tube in children undergoing elective surgeries in the prone position
Brief summary describing the background and objectives of the trial Background and objectives This study was designed to compare the use of the classic laryngeal mask airway versus endotracheal tube in children undergoing minor surgeries in the prone position. Insertion of endotracheal tube requires the use of direct laryngoscopy, which may cause sympathetic stimulation and laryngopharyngeal complications [1]. Supraglottic airway devices have been used to maintain the airway as they are less invasive compared to endotracheal tubes[2]. The laryngeal mask airway is a supraglottic device used to maintain the airway during surgery[3]. It is used widely to maintain the airway in general anesthesia for many surgeries in children[4] . This device has many advantages over tracheal tubes[5] , it is easily inserted[6] , causes less homodynamic effects [7] , and few complication for the larynx and vocal cords[8,9] . The LMA is effective during spontaneous and positive pressure ventilation [10] . it has been used successfully in adult patients who needed controlled ventilation during operations in prone position[11] . The maintenance of anesthesia with LMA in the prone position is controversies ,some anesthetists prefer it due to easy insertion and ventilation, low rate of dislodgement[12]. It has been used to maintain airway in prone position for spontaneously breathing patients and controlled ventilation[13]. The use of the LMA in surgeries performed in prone position has been increasing[14] Anesthetists used LMA in spontaneously breathing patients in prone position [15,16] and as a successful rescue device in cases of displaced endotracheal tubes in prone position[17]. Alexander Ng et al [18] reported that it can be used to induce and maintain anesthesia in the prone position without significant complications. No previous reports compared the use of classic laryngeal mask airway to the endotracheal tube in children undergoing elective surgeries in prone position.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied 40 ASA I children, aged 4-8 years old undergoing elective minor surgeries under general anesthesia in the prone position,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Supportive care
Anticipated trial start date 01/09/2016
Actual trial start date 01/09/2016
Anticipated date of last follow up 15/04/2017
Actual Last follow-up date 15/04/2017
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants) 40
Recruitment status Closed to recruitment,follow-up continuing
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 For randomization, a computer-generated random numbers was used and the numbers were concealed in opaque sealed envelopes. For randomization, a computer-generated random numbers was used and the numbers were concealed in opaque sealed envelopes. Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Group I (n=20): The patients airway was secured by uncuffed orotracheal tube Group I (n=20): The patients airway was secured by uncuffed orotracheal tube of surgery till revovery Group I (n=20): The patients airway was secured by uncuffed orotracheal tube 20
Experimental Group Group II (n¿=¿20) :The patient¿s airway was secured by a well lubricated laryngeal mask airway Group II (n¿=¿20) :The patient¿s airway was secured by a well lubricated laryngeal mask airway of surgery till revovery Group II (n¿=¿20) :The patient¿s airway was secured by a well lubricated laryngeal mask airway 20
Experimental Group Group II (n=20) :The patients airway was secured by a well lubricated laryngeal mask airway Group II (n=¿20) :The patients airway was secured by a well lubricated laryngeal mask airway of surgery till revovery Group II (n=20) :The patients airway was secured by a well lubricated laryngeal mask airway 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
40 ASA I children, aged 4-8 years old undergoing elective minor surgeries under general anesthesia in the prone position Exclusion criteria included patients with head anomalies, Down syndrome, patients scheduled for major or head and neck surgery, history or suspected difficult intubation, history of reactive airway or risk of aspiration. 4 Year(s) 8 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 19/03/2017 FM-BSU REC
Ethics Committee Address
Street address City Postal code Country
BeniSuief University hospital,Egypt BeniSuief 000 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Mean and peak airway pressure intraoperative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Beni-Suef University Hospital BeniSuief University hospital BeniSuief 000 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
no funding BeniSuief University hospital,Egypt, BeniSuief University hospital,Egypt BeniSuief 00 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Hatem Elmoutaz Beni-Suef University hospital BeniSuief 000 Egypt University
Secondary Sponsor doaa rashwan Beni-Suef University hospital BeniSuief University hospital,Egypt 000 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Hatem Elmoutaz BeniSuief University hospital,Egypt, BeniSuief University hospital,Egypt BeniSuief University hospital,Egypt 000 Egypt
doaa rashwan BeniSuief University hospital,Egypt, BeniSuief University hospital,Egypt BeniSuief University hospital,Egypt 000 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Hatem Elmoutaz doaa_rashwan@hotmail.com 00201011270763 BeniSuief University hospital,Egypt, BeniSuief University hospital,Egypt
City Postal code Country Position/Affiliation
BeniSuief University hospital,Egypt 000 Egypt assitant professor
Role Name Email Phone Street address
Public Enquiries doaa rashwan doaa_rashwan@hotmail.com 00201011270763 BeniSuief University hospital,Egypt, BeniSuief University hospital,Egypt
City Postal code Country Position/Affiliation
BeniSuief 000 Egypt assitant professor
Role Name Email Phone Street address
Scientific Enquiries doaa rashwan doaa_rashwan@hotmail.com 00201011270763 BeniSuief University hospital,Egypt
City Postal code Country Position/Affiliation
BeniSuief 000 Egypt Assitant professor
REPORTING
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