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.: PACTR201610001832267 Date of Approval: 23/10/2016
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Cleft palate airway management
Official scientific title Feeding obturator as an airway adjunct during complete unilateral cleft palate repair
Brief summary describing the background and objectives of the trial Cleft lip with or without palate is one of the common congenital malformations.( ) Correction of craniofacial deformities in children is highly challenging to anesthesiologists. The majority of anesthetic morbidity related to these procedures relates to the airway; either difficulty with intubation, inadvertent extubation during the procedure or postoperative airway obstruction. The defect in the palate together with the presence of abnormal dentition makes face mask ventilation and laryngoscopy difficult. Improper or lengthy management of the airway in such group of patients may lead to inadvertent consequences. A feeding obturator is a device that creates a seal between the oral and nasal cavities and helps the infant during feeding. It may be made of different materials. It is designed based on the age of the infant as well as the size of the defect. Primary aim is to assess the effect of application of the feeding obturator on the cormack Lehane¿s classification of the laryngeal view in infants with unilateral complete cleft palate. Secondary aim is to detect any possible implications of the feeding obturator on face mask ventilation, easiness of laryngoscopy and intubation and the incidence of side effects during the process of airway management in such group of patients.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Cleft palate repair,Paediatrics,Respiratory,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 25/10/2016
Actual trial start date 25/10/2016
Anticipated date of last follow up 31/05/2017
Actual Last follow-up date
Anticipated target sample size (number of participants) 80
Actual target sample size (number of participants) 80
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
nil known 44/16/19/10/2016
nil known 44/16/19/10/2016
nil known 44/16/19/10/2016
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 Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group No feeding device Once Induction duration No feeding device will be used during induction of anesthesia 40 Active-Treatment of Control Group
Experimental Group Feeding device Once Induction duration Infants will be referred to the pedodonotics department preoperatively to design a special sized feeding obturator. Induction of anesthesia will be done with the obturator in place 40
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
¿ Infants less than one year of age. ¿ ASA class I ¿ II Syndromatic difficult airway 1 Month(s) 1 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 28/09/2016 Ethics committee, Faculty of Medicine, Alexandria University
Ethics Committee Address
Street address City Postal code Country
Faculty of Medicine, Alexandria University, 17 Champolion street, Elmessalah, Alexandria, Egypt Alexandria 26051 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome To assess the effect of application of the feeding obturator on the cormack Lehane¿s classification of the laryngeal view in infants with unilateral complete cleft palate During intubation
Secondary Outcome to detect any possible implications of the feeding obturator on face mask ventilation, easiness of laryngoscopy and intubation and the incidence of side effects during the process of airway management in such group of patients During face mask ventilation and intubation
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Alexandria University Hospitals 17 Champolion street, Elmessalah Alexandria 26051 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Alexandria, Faculty of Medicine 17 Champolion street, Elmessalah Alexandria 26051 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Alexandria Faculty of Medicine 17 Champolion street, Elmessalah Alexandria 26051 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Moustafa Abdelaziz Moustafa Antoniadis compound C2 B7, Smouha Alexandria 21231 Egypt
Alaa Abdelrahman Moustafa Kandil Faculty of Medicine, Department of Anesthesia Alexandria 26051 Egypt
Ahmed Serag Eldin Habib Faculty of Dentistry, Department of Maxillofacial surgery Alexandria 26051 Egypt
Shady Aly Ahmed Faculty of Dentistry, Department of Maxillofacial surgery Alexandria 26051 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Moustafa Moustafa moustafa.abdelaziz@alexmed.edu.eg +201222373407 Antoniadis compound C2B7, Smouha
City Postal code Country Position/Affiliation
Alexandria 21231 Egypt Assistant Professor
Role Name Email Phone Street address
Public Enquiries Maha Ghanem maha.ghanem@alexmed.edu.eg +201223374415 17 Champolion street, Elmessalah
City Postal code Country Position/Affiliation
Alexandria 26051 Egypt Chaiman of ethics committee
Role Name Email Phone Street address
Scientific Enquiries Nagwa Elkobbia kobbia@yahoo.com +201223368233 17 Champolion street, Elmessalah
City Postal code Country Position/Affiliation
Alexandria 26051 Egypt Professor at Anesthesia department
REPORTING
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