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.: PACTR201807132391075 Date of Approval: 16/07/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Ventilation strategy of ARDS management
Official scientific title Driving Pressure Guided Ventilation versus Protective Lung Ventilation in Acute Respiratory Distress Syndrome (ARDS) Patients: Prospective Randomized Controlled Study
Brief summary describing the background and objectives of the trial Acute respiratory distress syndrome (ARDS) is a frequent disease that affects up to 23% of mechanically ventilated patients over the course of the intensive care unit (ICU) stay. Protective lung ventilation strategy which utilizes application of appropriate (optimal) level of positive end-expiratory pressure (PEEP), use of low tidal volume VT (4-8 ml/kg) of the predicted body weight and limitation of plateau pressure below 30 cmH2O has been established that are the standards of ARDS management and associated with decreased mortality. Based on the fact that the pathology of ARDS is heterogeneous, the appropriate value of PEEP for some lung areas may cause over inflation for other areas. Recently, a retrospective analysis of several trials in patients with ARDS comparing different PEEP levels at the same VT or different VT levels at the same PEEP, or a combination of both, found that driving pressure (DP) which is the difference between the airway pressure at the end of inspiration (plateau pressure, (Ppl) and PEEP) is the stronger predictor of mortality as compared with low VT and Ppl.(4) Furthermore, the relative risk of mortality significantly increased above a threshold of 15 cm H2O. It is important to emphasize at this point that the threshold of a driving pressure of 14 or 15 cmH2O to predict the outcome or titrate VT has not been validated or confirmed
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Respiratory
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Supportive care
Anticipated trial start date 01/07/2018
Actual trial start date 04/07/2018
Anticipated date of last follow up 30/06/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 110
Actual target sample size (number of participants)
Recruitment status Active, not 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 Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Control Group Protective lung ventilation will be used for management of the ARDS Till the patient satisfy the goals for weaning from mechanical ventilation The routine protective lung strategy for management of the ARDS will be used 55 Active-Treatment of Control Group
Experimental Group Driving pressure guided PEEP The choice of PEEP of the patient in this group will be based upon the driving pressure (DP) to keep DP ≥ 14 cmH2O. Until the patient fulfilled the criteria of weaning from mechanical ventilation The choice of PEEP of the patient in this group will be based upon the driving pressure (DP) to keep DP ≥ 14 cmH2O. All patients will be followed up and receive sedative and/or narcotic, also, neuromuscular blocking drugs will be used as required. All patients will be managed by the same protocol of weaning, as per unit protocol:(5)  The cause of ARDS is cured or under control.  PEEP is < 6 cmH2O.  PaO2/FiO2 > 200 mmHg.  Hemodynamic stability. 55
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients aged 18 years or older and fulfill the Berlin definition of ARDS (5) will be included:  Acute onset within one week  (PaO2/FiO2) less than 300 mmHg with a minimum PEEP of 5 cmH2O  Bilateral lung opacities consistent with pulmonary edema on chest radiogram or lung ultrasound  Cardiac failure and fluid overload should be excluded in absence of definite cause of ARDS Patients aged 18 years or older and fulfill the Berlin definition of ARDS (5) will be included:  Acute onset within one week  (PaO2/FiO2) less than 300 mmHg with a minimum PEEP of 5 cmH2O  Bilateral lung opacities consistent with pulmonary edema on chest radiogram or lung ultrasound  Cardiac failure and fluid overload should be excluded in absence of definite cause of ARDS Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 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 18/06/2018 Research Ethics Committee of Tanta Faculty of Medicine
Ethics Committee Address
Street address City Postal code Country
Algeish st Tanta 31511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 28th day mortality Within the first 28 days of mechanical ventilation
Secondary Outcome Oxygenation by PaO2 / FiO2 After any change in the ventilation parameters daily
Secondary Outcome Lung compliance. Daily
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tanta University Hospitals Algeish st Tanta 31511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Tanta University Hospitals Algeish st Tanta 31511 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Khaled Mohammed Sayed Ahmed Hamama Algeish st Tanta 31511 Egypt
Salah Eldeen Ibrahim Alsherif Ibn Alfared st Tanta 31511 Egypt
Reda Sobhi Salamh Abd Alrahman Botros st Tanta 31511 Egypt
Sameh Mohammed Fathy Tout Ankh-Amoun st Tanta 31511 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Khalid Hamama khal3odmh@gmail.com 00201011195639 Algeish st
City Postal code Country Position/Affiliation
Tanta 31511 Egypt Assistant lecturer at the Department of Anesthesia and Intensive Care Tanta Faculty of Medicine
Role Name Email Phone Street address
Scientific Enquiries Sohair Soliman sohairsoliman@hotmail.com 00201283929049 Moheb st
City Postal code Country Position/Affiliation
Tanta 31511 Egypt Professor of Anesthesia and Intensive Care Faculty of Medicine Tanta University
Role Name Email Phone Street address
Public Enquiries Fatheya Khalil Fatheya.khalil@magrabi.com 00201221218694 Alhelw st
City Postal code Country Position/Affiliation
Tanta 31511 Egypt Head of Operating Room of Magrabi eye hospital for eyes Tanta
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Undecided
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
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