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.: PACTR202204746577792 Date of Registration: 14/04/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Patient Self-Proning with High-Flow Nasal Cannula Improves Oxygenation in ARDS Patients: A Randomized Clinical Trial
Official scientific title Patient Self-Proning with High-Flow Nasal Cannula Improves Oxygenation in ARDS Patients: A Randomized Clinical Trial
Brief summary describing the background and objectives of the trial The aim of this work is to evaluate the effect of self proning with high flow nasal cannula in patients with ARDS on oxygenation and incidence of intubation
Type of trial RCT
Acronym (If the trial has an acronym then please provide) Proning and HFNc
Disease(s) or condition(s) being studied Respiratory
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 28/12/2020
Actual trial start date 06/06/2021
Anticipated date of last follow up 06/07/2022
Actual Last follow-up date 06/07/2022
Anticipated target sample size (number of participants) 90
Actual target sample size (number of participants) 90
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Proning and HFNC Proning 8 hours twice daily 16 hours per day patients will be subjected to HFNC with a target of SPO2 > 90% with FiO2 ≤ 0.6. In this group HFNC will be combined with Self proning. At first self proning will be applied with HFNC for at least 30min, if the patient tolerates the prone position well prone position will be maintained. Duration of prone position will be 8 hours per day. 45
Control Group HFNC to patient with mild ARDS all over the day in the first 28 days of surgical ICU admission. On admission to surgical ICU patient who will be diagnosed in the first 24 hours with ARDS according to Berlin criteria will be subjected to NIV (CPAP/BIPAP mode) FIO2 0.5 PEEP 5cm H2O for 30min. Followed by an ABG analysis and according to PaO2/FiO2 ratio a patient will be classified as: Mild ARDS: An oxygenation abnormality with PaO2/FiO2 ratio of 200-300. Moderate ARDS: A PaO2/FIO2 ratio of 100-200. Severe ARDS: A PaO2/FIO2 ratio of 100 or less. Patient with mild ARDS (PaO2/FiO2 ratio of 200-300) will be included this study and randomly divided by alternation into 2 groups by simple randomization. In group 1: patients will be subjected to HFNC with a target SPO2 ≥ 90% with FiO2 < 0.6. 45 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Mild ARDS Age>18 BMI<30 Moderate to severe ARDS Contraindications of proning e.g vitally instability Immediate need of intubation Refusal of prone position 80 and over: 80+ Year,Adult: 18 Year(s)-44 Year(s),Aged: 65 Year(s)-79 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 80 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 28/12/2020 Research Ethics committee at the faculty of medicine Ain shams university
Ethics Committee Address
Street address City Postal code Country
38 Abbassia.Next to the Al-Nour Mosque cairo 1181 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 28/12/2020 Research ethics committee at the faculty of medicine Ain shams university
Ethics Committee Address
Street address City Postal code Country
38 abbasia, Next to the el Nour mosque Cairo 1181 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 28/12/2020 Research ethics committee at the faculty of medicine ain shams
Ethics Committee Address
Street address City Postal code Country
38 abbassia next to the al nour mosque Cairo 1181 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Our primary outcomes will be rate of intubation. End point of the study will be improvement of the patient or worsening of his condition and proceeding to intubation. in the first 28 days of surgical ICU admission.
Secondary Outcome Our secondary outcomes will be measurement of complications of prone position and the period of ICU stay and mortality rate in the first 28 days of surgical ICU admission. in the first 28 days of surgical ICU admission.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Faculty of Medicine Ain Shams University 38 abbassia square.Next to Al-Nour Mosque Cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
The principal investigator 42 mohamed aid shalan madinat elnour alzawia elhamra Cairo Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of medicine Ain shams university 38 Abbassia. Next to the Al-Nour Mosque cairo 1181 Egypt University
COLLABORATORS
Name Street address City Postal code Country
beshoy zarief nassar 42 mohamed aid shalan madinat elnour elzawia elhamra cairo Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Public Enquiries beshoy zarief nassar beshoyzarief1@gmail.com +201557699386 42 mohamed aid shalan st madinat elnour elzawia elhamra
City Postal code Country Position/Affiliation
cairo Egypt assistant lectureral
Role Name Email Phone Street address
Scientific Enquiries Dr mohamed Sidky Wildeagle1@hotmail.com +201221198998 Elshorouk basio 4
City Postal code Country Position/Affiliation
Cairo Egypt Professor of anesthesia Faculty of medicine ain shams university
Role Name Email Phone Street address
Principal Investigator Dr Noura Mohamed Noura.youssri@gmail.com +201003367625 Compound zizinia new cairo
City Postal code Country Position/Affiliation
Cairo Egypt Lecturer of anesthesia Faculty of medicine ain shams university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of individual participant data collected during the trial after deidentification Study Protocol Following publication Any purpose
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