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.: PACTR201702001877334 Date of Approval: 19/11/2016
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Fibreoptic bronchoscopy guided intubation in morbid obes
Official scientific title Awake fibreoptic bronchoscopy in morbid obese, a new technique.
Brief summary describing the background and objectives of the trial Endotracheal intubation in morbid obese patients is considered an anesthetic challenge. this is caused y multiple anatomical and functional changes in both airway and respiratory system. in this trial, authors offer a true technique for FOB guided ETT insertion that is supposed to save time and increase success rate.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied bariatric surgery,Respiratory
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/12/2016
Actual trial start date 01/01/2017
Anticipated date of last follow up 01/08/2017
Actual Last follow-up date 20/11/2017
Anticipated target sample size (number of participants) 70
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
nil known ministry of higher education-Egypt
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 closed envelope technique Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group fibroptic bronchoscopy Insertion ETT using fibroptic bronchoscopy in classic technique starting navigation from mouth opening 35 Active-Treatment of Control Group
Control Group Prenavigation group classic Fibroptic bronchoscopy after induction of anesthesia 35
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All morbid obese patients scheduled for bariatric surgery in gastroenterology center, Mansoura, egypt Patient refusal anticipated difficult intubation 20 Year(s) 50 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 20/11/2016 institutional research board
Ethics Committee Address
Street address City Postal code Country
Algomhoreya street Mansoura Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome time to endotracheal tube insertion ( seconds) before anesthesia induction
Secondary Outcome complications (hypoxia-bleeding-bronchosapsm) at anesthesia induction
Secondary Outcome success rate after indcution of anesthesia
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Gastroenterology center Geihanstreet MAnsoura 36615 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
none
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mansoura university MAnsoura Egypt University
COLLABORATORS
Name Street address City Postal code Country
none
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Alreafey Kandeel refa3ey2@yahoo.com 002 01008158591 Geihan street
City Postal code Country Position/Affiliation
Mansoura Egypt lecturer of anesthesia- Mansoura university
Role Name Email Phone Street address
Public Enquiries Alreafey Kandeel refa3ey2@yahoo.com 00201008158591 geihan street
City Postal code Country Position/Affiliation
Mansoura 35516 Egypt Lecturer of anesthesia-Mansoura university
Role Name Email Phone Street address
Scientific Enquiries Alreafey Kandeel refa3ey2@yahoo.com 00201008158591 geihan street
City Postal code Country Position/Affiliation
Mansoura 35516 Egypt Lecturer of anesthesia-Mansoura university
REPORTING
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Result URL Hyperlinks
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