Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
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Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201607001705678 Date of Approval: 06/07/2016
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Parker Flex-Tip tube for nasotracheal intubation
Official scientific title Nasotracheal intubation with Parker Flex-Tip versus preformed nasal endotracheal tubes for children undergoing adenotonsillectomy
Brief summary describing the background and objectives of the trial The design of the endotracheal tube might be an important factor in the incidence of injurious complications during nasotracheal intubation. Aim of the work: Primary aim: to compare the parker flex tip (PFT) and the preformed nasal (PNT) tubes regarding the ease of insertion during nasotracheal intubation in children undergoing adenotonsillectomy. Secondary aim: to verify the incidence of traumatic complications of both types of tubes during nasotracheal intubation in children undergoing adenotonsillectomy
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Adenotonsillectomy,Ear, Nose and Throat,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 30/07/2015
Actual trial start date 30/07/2015
Anticipated date of last follow up 15/03/2016
Actual Last follow-up date 15/03/2016
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants) 100
Recruitment status Completed
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 Simple randomisation using a radomisation table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Group PFT Once Perioperative Nasal intubation 50
Control Group Group PNT Once Perioperative Intubation 50 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Age between 4 and 10 years ASA physical status I-II Scheduled for adenotonsillectomy Contraindications to nasotracheal intubation such as coagulopathy, known or suspected CSF leak Anticipated difficult intubation in the form of known congenital airway anomalies 4 Year(s) 10 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 15/07/2015 Alexandria Faculty of Medicine ethics committee
Ethics Committee Address
Street address City Postal code Country
Faculty of Medicine - ElKhartoom square ¿ Elazzarita Educational building ¿ 6th floor Alexandria 26151 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome to compare the PFT and the preformed nasal (PNT) tubes regarding the ease of insertion during nasotracheal intubation in children undergoing adenotonsillectomy Postoperatively
Secondary Outcome to verify the incidence of traumatic complications of both types of tubes during nasotracheal intubation in children undergoing adenotonsillectomy Postoperatively
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Alexandria Faculty of Medicine Alsultan Hussein, Alazarita Alexandria 26151 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Self fund
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Alexandria Faculty of Medicine Alsultan Hussein - Alazarita Alexandria 26151 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Moustafa Abdelaziz Moustafa Smouha, Antoniadis compound C2B7 Alexandria 21311 Egypt
Yasser Mohamed Ossman Alazarita - Alsultan Hussein Alexandria 26151 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Moustafa Moustafa m.3abdelaziz@hotmail.com +2033852130 Smouha, Antoniadis compound C2B7
City Postal code Country Position/Affiliation
Alexandria 21311 Egypt Assistant professor of Anesthesia and Surgical Intensive Care , Alexandria Faculty of Medicine
Role Name Email Phone Street address
Public Enquiries Maha Ghanem ghanemmaha@yahoo.com +2 012 749 8435 Faculty of Medicine - ElKhartoom square ¿ Elazzarita Educational building ¿ 6th floor
City Postal code Country Position/Affiliation
Alexandria 26151 Egypt Chairman of Ethics committee
Role Name Email Phone Street address
Scientific Enquiries Nagwa Elkobbia kobbia@yahoo.com +201223368233 Alsultan Hussein - Alazarita
City Postal code Country Position/Affiliation
Alexandria 26151 Egypt Professor of Anesthesia and Surgical Intensive Care
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