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.: PACTR201602001476292 Date of Approval: 16/02/2016
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Ultrasoung guided intubation
Official scientific title Endotracheal Intubation: Ultrasound Guided versus Fiberscope in Patients with Cervical Spine Immobilization
Brief summary describing the background and objectives of the trial Background: Ultrasound has growing applications in airway management during anesthesia. The aim of the present study is to evaluate the feasibility of real time ultrasound guided intubation in patients with cervical spine immobilization relative to fiberoptic intubation.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) Ultrasound guided in
Disease(s) or condition(s) being studied ,Nervous System Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Devices
Anticipated trial start date 20/02/2016
Actual trial start date 20/02/2016
Anticipated date of last follow up 20/08/2016
Actual Last follow-up date
Anticipated target sample size (number of participants) 266
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
Alexandria Faculty of Medicine, Egypt Ethics Committee of the Alexandria Main University Hospitals, 16/6/2011, IRB NO: 00007555-FWA NO:000
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 coin tossing 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 A (US) Once till intubation Ultrasound guided intubation 133 Active-Treatment of Control Group
Control Group Group B (fiberoptic) Once Till Intubation Fiberoptic guided intubation 133 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients will be selected from those who have a rigid neck collar in place for cervical spine immobilization Airway anomalies 18 Year(s) 70 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 Alexandria medical ethical committee
Ethics Committee Address
Street address City Postal code Country
17, Champolion st Alexandria 21131 Egypt
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 Alexandria medical ethical committee
Ethics Committee Address
Street address City Postal code Country
17, Champolion st Alexandria 21131 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Success rate of intubation After successful intubation guided by the capnogram
Secondary Outcome Complications, hemodynamic derangements During and after intubation
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Alexandria Faculty of Medicine Alsultan Hussein street Alexandria 26051 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 street Alexandria 21311 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Emad Abdelmoneim Arida Alsultan Hussein Alexandria 21311 Egypt
Ola M. Zanaty Alsultan Hussein Alexandria 21311 Egypt
Moustafa A. Moustafa Alsutan Hussein Alexandria 21311 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Moustafa Moustafa m.3abdelaziz@hotmail.com +201222373407 Alnasr st, Alboroug, building 5
City Postal code Country Position/Affiliation
Alexandria 25651 Egypt Assistant professor
Role Name Email Phone Street address
Public Enquiries Maha Ghanem alexmedethics@yahoo.com 002034862506 17, Champolion st
City Postal code Country Position/Affiliation
Alexandria 21311 Egypt Chairman of thics committee
Role Name Email Phone Street address
Scientific Enquiries Nader Elgamal nelgamal@yahoo.com +201223187899 alsultan Huusein st, Faculty of Medicine, Anesthesia department
City Postal code Country Position/Affiliation
Alexandria 21311 Egypt Chairman of Anesthesia department
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
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