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.: PACTR201802003139104 Date of Approval: 23/02/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title The utility of Quantitative EEG following cardiac arrest
Official scientific title The utility of Quantitative EEG following cardiac arrest
Brief summary describing the background and objectives of the trial Quantitative EEG (QEEG) techniques have been utilized to evaluate hypoxic ischemic encephalopathy following cardiorespiratory arrest, however the use of many new expensive software programs is limited by availability. In this study we explored the value of common QEEG techniques as frequency analysis in the assessment of a series of patients following cardiac arrest.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Circulatory System,hypoxic ischemic encephalopathy,Injury, Occupational Diseases, Poisoning
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 01/12/2013
Actual trial start date 01/12/2013
Anticipated date of last follow up 15/11/2015
Actual Last follow-up date 15/11/2015
Anticipated target sample size (number of participants) 0
Actual target sample size (number of participants) 40
Recruitment status Stopped early/ terminated
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 Non-randomised Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group QEEG poor outcome analysis 3 one hour quantitative electroencephalography poor outcome analysis 22
Control Group QEEG good outcome analysis 3 one hour quantitative electroencephalography good outcome analysis 18 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
hypoxic ischemic encephalography post cardiac arrest age less than 18 years history of liver or kidney dysfunction history of intracranial pathology e.g. tumor , stroke 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 04/03/2013 Ethics committee of the department of neurology and Clinical neurophysiology , faculty of medicine, Cairo university
Ethics Committee Address
Street address City Postal code Country
27 Nafezet Sheem El Shafaey street Kasr Alainy Cairo 11562 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Alpha power is decreased and delta power is increased in patients with bad neurological outcome after cardiac arrest day 1 post arrest day 3 post arrest day 7 post arrest
Secondary Outcome QEEG may used in prediction of poor neurological outcome after resuscitation from cardiac arrest day 1 post arrest day 3 post arrest day 7 post arrest
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
National heart institute 5 Ibn El Nafees Square Giza 12651 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Beni Suef University Mokbel district Beni Suef 62511 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Beni Suef University Mokbel district Beni Suef 62511 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Prof. Dr. Hanan Hosny Mokbel district, faculty of medicine Beni Suef 62511 Egypt
Prof. Dr. Mona Nada 27 Nafezet Sheem El Shafaey street, Kasr Alainy , faculty of medicine Cairo 11562 Egypt
Prof. Dr. Ehab Shaker 27 Nafezet Sheem El Shafaey street, Kasr Alainy , faculty of medicine Cairo 11562 Egypt
Asst. Prof.Dr. Amani Nawito 27 Nafezet Sheem El Shafaey street, Kasr Alainy , faculty of medicine Cairo 11562 Egypt
Prof. Dr. Mohamed Seleem 5 Ibn El Nafees Square, National Heart Institute Giza 12651 Egypt
Dr. Rehab Hassan Mokbel district, faculty of medicine Beni Suef 62511 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Hanan Hosny hhneurophysio_edu@yahoo.com +201001464397 Faculty of Medicine , Mokbel District
City Postal code Country Position/Affiliation
Beni Suef 62511 Egypt Head of Clinical Neurophysiology department, Faculty of Medicine, Beni Suef University
Role Name Email Phone Street address
Public Enquiries Hanan Hosny hhneurophysio_edu@yahoo.com +201001464397 Faculty of Medicine , Mokbel District
City Postal code Country Position/Affiliation
Beni Suef 62511 Egypt Head of Clinical Neurophysiology department, Faculty of Medicine, Beni Suef University
Role Name Email Phone Street address
Scientific Enquiries Amani Nawito amani.nawito@kasralainy.edu.eg +201006077405 27 Nafezet Sheem El Shafaey street, .Kasr Alainy
City Postal code Country Position/Affiliation
Cairo 11562 Egypt Assistant Professor of Clinical Neurophysiology , faculty of medicine, Cairo University
REPORTING
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