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.: PACTR201807466395693 Date of Registration: 16/07/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title LMA in tongue trauma
Official scientific title Evaluation of the flexible laryngeal mask airway (LMA Flexible) in tongue trauma repair in children
Brief summary describing the background and objectives of the trial Tongue trauma usually occurs in children by teeth due to falls on the ground or a blow and sometimes during an epileptic fit in epileptic children. It is classically repaired by sutures under various anesthetic techniques which include for example: monitored sedation (which has a risk of aspiration of blood and saliva), or more commonly general endotracheal anesthesia which albeit safe regarding aspiration risk, but has many disadvantages in children including not all: cough , gagging , reflex bronchospasm , relatively long time for induction and recovery considering that it is a short surgical procedure. Laryngeal mask airway is widely used in a variety of pediatric surgeries and had been studied in some oral surgeries as tonsillectomy with success. In this study, we evaluate the feasibility and safety of the use of flexible laryngeal mask airway in comparison to the endotracheal tube in tongue laceration repair.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Supportive care
Anticipated trial start date 14/07/2018
Actual trial start date
Anticipated date of last follow up 13/10/2018
Actual Last follow-up date
Anticipated target sample size (number of participants) 90
Actual target sample size (number of participants)
Recruitment status Completed
Publication URL https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6820298/
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 randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Endotracheal tube Group Throughout the whole time of repair of tongue trauma A cuffed endotracheal tube (size according to patient age and weight) will be used to secure the airway, and the patient will be extubated awake at the end of surgery after adequate suction of secretions and/or blood. 30 Active-Treatment of Control Group
Experimental Group Laryngeal mask airway Group Till recovery and extubation of the patient Flexible LMA (size according to patient weight) will be used to secure airway, and will be removed at the end of surgery under deep level of anesthesia after adequate suction of secretions and/or blood. 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients ASA I and II Aged 2 to 5 years Admitted for tongue laceration repair under general anesthesia, with adequate fasting.  Patients with full stomach  Patients in active bleeding  Patients with tongue hematoma  History of gastro-esophageal reflux Preschool Child: 2 Year-5 Year 2 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 18/05/2018 Research Ethics Committee of Faculty of Medicine Tanta University
Ethics Committee Address
Street address City Postal code Country
Algeish st Tanta 31511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Time for extubation from the end of the surgery till complete recovery
Secondary Outcome Hemodynamic response at induction and recovery (Heart rate, non-invasive blood pressure, oxygen desaturation Immediately after airway control
Secondary Outcome Postoperative adverse events (stridor, sore throat, dysphonia) From discharge of the patient to the recovery room till discharge from the hospital
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tanta University Hospitala Algeish st Tanta 31511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Tanta University Hospitals Algeish st Tanta 31511 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Tamer Mohamed Naguib Alestad st Tanta 31511 Egypt
Sameh Abdelkhalik Ahmed Saied st Tanta 31511 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Tamer Naguib tnaguib1eg@yahoo.com 00201002937050 Alestad st
City Postal code Country Position/Affiliation
Tanta 31511 Egypt Lecturer of Anesthesia and Intensive Care Tanta Faculty of Medicine
Role Name Email Phone Street address
Scientific Enquiries Sohair Soliman sohairsoliman@hotmail.com 00201283929049 Moheb st
City Postal code Country Position/Affiliation
Tanta 31511 Egypt Professor of Anesthesia and Intensive Care Faculty of Medicine Tanta University
Role Name Email Phone Street address
Public Enquiries Osama Algazar doctorosama@yahoo.com 00201226156119 Algeish st
City Postal code Country Position/Affiliation
Tanta 31511 Egypt Anesthesia specialist at Tanta General Hospital
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Undecided
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