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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202311877094703 Date of Registration: 09/11/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title RedVent2021
Official scientific title Safety and Performance Evaluation of Locally made Mechanical ventilator in Ethiopia, Single-arm open-label study
Brief summary describing the background and objectives of the trial Respiratory failure is considered when the respiratory system fails to secure its gas exchange function between the blood and ambient air. It can be hypoxemic when an arterial oxygen tension (PaO2) is lower than 60 mm Hg, or Hypercapnic, when low arterial carbon dioxide tension (PaCO2) higher than 50 mm Hg. Coronavirus disease 2019 (COVID-19) caused by Coronavirus affects the respiratory tract. The COVID-19 pandemic has posed a shortage of mechanical ventilators worldwide, especially in the resource-limited setting. Mechanical ventilation is an essential part of therapy in patients with severe respiratory failure. However, mechanical ventilation itself may cause alveolar injury or worsen an established disease. The Redawa-mechanical ventilator is designed to provide invasive ventilation for patients in respiratory distress with the intension of using it when conventional commercial invasive ventilators are not available in the context of the health emergency such as due to the COVID-19 epidemic. A similar mechanical ventilator for similar purpose are developed in different regions and in Colombia it is undergoing clinical trial to test performance and safety. By the two rounds of rigorous technical and bench evaluation and supervisory visit, a technical team suggested the device has to undergo a clinical trial procedure for an emergency use in limited resource settings with minor modifications. The objective was to assess the safety and efficacy of REDAWA mechanical ventilator in treating patients with respiratory failure
Type of trial Non-Randomised
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 Treatment: Devices
Anticipated trial start date 08/09/2021
Actual trial start date 08/09/2021
Anticipated date of last follow up 08/02/2022
Actual Last follow-up date 28/08/2022
Anticipated target sample size (number of participants) 10
Actual target sample size (number of participants) 4
Recruitment status Completed
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
Single Group Non-randomised Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Mechanical ventilator for 24 hours 24 hours Redawa ambu-bag-based mechanical ventilator uses invasive and positive airway pressure to provide volume controlled ventilation for patients who are unable to breathe by themselves. It has three modes of ventilation which are volume controlled and pressure regulated namely:continuous mandatory ventilation (CMV), assist/control (A/C) and synchronized intermittent mode (SIM). It also creates positive airway pressure by compressing the conventional ambu bag with pivoting arm actuator moving by electrical motors.. Ambu bag is squeezed by electric motor powered and has internally imbedded rechargeable battery 4
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Participant/next of keen is willing and able to give informed consent for participation in the study. Male or Female, aged 18 years or above. Diagnosed to have acute respiratory failure and meet indication for volume controlled mechanical ventilation • Female participants who is pregnant • Patients with hypotension MAP<65mmHg • Cerebral edema in cerebral protection and / or suspected endocranial hypertension • SOFA >9 • Not willing to give consent • Patients with ARDS 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) 19 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 24/03/2021 AHRIALERT ethics review committee
Ethics Committee Address
Street address City Postal code Country
Addis Ababa Addis Ababa 1005 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 1. Safety and tolerability as measured by subject incident of treatment-emergent adverse events[ Time Frame: 24hrs ] 2. Improvement or maintenance of the oxygenation level measured by PaO2 Maintenance: less than 20% drop in PaO2 with respect to the baseline measurements made in the 30 minutes before connecting the REDAWA ventilator 3. Improvement or maintenance of oxygen level measured by oxygen saturation Maintenance: less than 20% drop in oxygen saturation with respect to the baseline measurements made in the 30 minutes before connecting REDAWA mechanical ventilator. 4. Improvement or maintenance of adequate levels of carbon dioxide measured by PaCO2 Maintenance: A change of less than 20% in the levels of PaCO2 with respect to the baseline measurements made in the 30 minutes before connecting the REDAWA mechanical ventilator every 30 minute
Secondary Outcome Improvement or maintenance of adequate levels of blood pH Maintenance: A change of less than 20% in the levels of pH with respect to the baseline measurements made in the 30 minutes before connecting the REDAWA mechanical ventilator 1. Cardiac arrest without a clinical explanation other than the ventilator 2. Death without a clinical explanation other than the ventilator 3. Uninterrupted and faultless operation in the period of use of the ventilator. 4. Decrease or increase in respiratory rate, tidal volume, PEEP, peak inspiratory pressure, not due to a clinician order but due to ventilator variability. 5. Hemodynamic deterioration in the hour following the start of REDAWA ventilator that requires a 100% increase in the dose of vasopressors and that does not have a clinical explanation other than the ventilator. every 30 minute
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
MenelikII Hospital Addis Ababa Adiss Ababa Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
Ministry of Health Ethiopia Addis Ababa Addis Ababa Ethiopia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Redawa motors Diredawa Diredawa Ethiopia Commercial Sector/Industry
Secondary Sponsor Ministry of Health Addis Ababa Addis Ababa Ethiopia Goverenment
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Kassa Merga kassa.haile@ahri.gov.et +251911396555 Addis Ababa
City Postal code Country Position/Affiliation
Addis Ababa 1005 Ethiopia Armauer Hansen Research Institute
Role Name Email Phone Street address
Principal Investigator Ananya Shiferaw abateananya@yahoo.com +251911826464 Addis Ababa
City Postal code Country Position/Affiliation
Addis Ababa Ethiopia Addis Ababa University college of health science
Role Name Email Phone Street address
Public Enquiries Addamu Kiltu addis.alemu@ahri.gov.et +251929041898 Addis Ababa
City Postal code Country Position/Affiliation
Addis Ababa Ethiopia Armauer Hansen Research Institute
Role Name Email Phone Street address
Scientific Enquiries Alemseged Abdissa alemseged.abdissa@ahri.gov.et +251944342892 Addis Ababa
City Postal code Country Position/Affiliation
Addis Ababa Ethiopia Armauer Hansen Research Institute
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The data generated in this study belongs to the study group as a whole. The final database will be shared amongst the site PI and key members of the research team. The deidentified database may be shared with researchers not directly involved in this study but only after the main paper has been published and in accordance with AHRI data sharing guideline. The database will only be shared if future publications are not compromised. Clinical Study Report After publication of the data Researchers who want to access the data
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