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.: PACTR201601001445764 Date of Approval: 27/01/2016
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Non-invasive Ventilation VS Simple face mask After Extubation After Cardiac Surgery
Official scientific title Use of Non-invasive Ventilation VS Simple face mask After Extubation After Cardiac Surgery
Brief summary describing the background and objectives of the trial Postoperative pulmonary dysfunction is quite common after cardiac surgery, ranging from mild hypoxemia to acute respiratory failure. Noninvasive ventilation (NIV) has been successfully applied in acute respiratory failure; recently it has been evaluated in the prevention and treatment of postoperative acute respiratory failure, including the cardiovascular setting.   The aim of this work is to assess the efficacy of non-invasive ventilation as a prophylactic transient ventilatory support after cardiac surgery in adult patients.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied ,Circulatory System,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Devices
Anticipated trial start date 01/06/2015
Actual trial start date 01/07/2015
Anticipated date of last follow up 31/05/2017
Actual Last follow-up date 31/05/2017
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants) 100
Recruitment status Recruiting
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 Permuted block randomisation (block size was variable minimum of 4) Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group NIV group will receive ventilator through an oro- nasal mask. The NIV support will be initiated at a level of 5 cm H2O expiratory positive airway pressure (EPAP) and 10¿12 cm H2O inspiratory positive airway pressure (IPAP) in a spontaneous mode. 50
Control Group oxygen-mask group 5 L/min immediately after extubation oxygen immediately after extubation through a facial mask with a flow of 5 L/min. 50 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Adult Patients ho will undergo elective on pump cardiac surgery. Disturbed consciousness level Severe uncontrolled agitation or uncooperative behavior Hemodynamic instability Respiratory arrest High risk of aspiration Excessive respiratory secretion Recent gastric or esophageal surgery Tracheostomized patients Lack of informed consent 18 Year(s) 60 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
No 01/02/2016 Menofia University IRB
Ethics Committee Address
Street address City Postal code Country
Yaseen abdelghafar Shibin el kom 32513 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome NIV success rate NIV success rate as a weaning from mechanical ventilation after cardiac surgery without need for reintubation.
Primary Outcome PaO2 ¿ 60 mmHg Will be measured through out the trial which will be held for about 6 hours after extubation
Primary Outcome PaCO2 ¿ 50 mm Hg Will be measured through out the trial which will be held for about 6 hours after extubation
Secondary Outcome ventilator associated pneumonia throughout the follow up period
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Menofia unversity hospital Yassin abdolghafar Shebin elkoom Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Menofia University Yassin abdolghafar Shebin elkoom 32513 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Department of Anaesthesia and Intensive Care, Menofia University Yassin abdolghafar Shebin elkoom 32513 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Mohamed Helmi Afifi Yassin abdolghafar Shebin elkoom 32513 Egypt
Abdel Rahman Ahmed Ahmed Yassin abdolghafar Shebin elkoom 32513 Egypt
Amal Gouda Saafan Yassin abdolghafar Shebin elkoom 32513 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohamed Afifi dr.mhafifi@gmail.com 002-01140441866 Yassin abdolghafar
City Postal code Country Position/Affiliation
Shebin elkoom 32513 Egypt Professor of Anesthesiology and Intensive Care
Role Name Email Phone Street address
Public Enquiries Elsayedamr Basma elsayedamr@yahoo.com 00201223106023 30 Garden City Smouha
City Postal code Country Position/Affiliation
Alexandria 21516 Egypt Patient Information Manager
Role Name Email Phone Street address
Scientific Enquiries Abdel Rahman Ahmed Doc_ag86@yahoo.com 002-01141975282 Yassin abdolghafar
City Postal code Country Position/Affiliation
Shebin elkoom 32513 Egypt Assistant Professor of Anesthesiology and Intensive Care
REPORTING
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