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.: PACTR202306684141777 Date of Approval: 22/06/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title BREATHE: Building Respiratory Support in East Africa Through High Flow versus Standard Flow Oxygen Evaluation
Official scientific title Building Respiratory Support in East Africa Through High Flow versus Standard Flow Oxygen Evaluation
Brief summary describing the background and objectives of the trial Acute hypoxemic respiratory failure is a significant issue in low-income countries (LICs). The COVID-19 pandemic has exacerbated the burden of respiratory failure in LICs. Oxygen and mechanical ventilators, essential for critical care, are extremely limited in LICs. Studies have shown that high flow oxygen therapy (HFO) has shown promising results in reducing mortality and the need for intubation in high-income countries. However, its effectiveness and implementation in LICs are unknown. This study aims to assess the impact of protocolized standard flow oxygen (SFO) and HFO on mortality and implementation factors in LICs. Establishing a standard of care for SFO is crucial to evaluate the specific impact of HFO. The study aims to improve understanding of the interventions' effects, cost-effectiveness, and real-world application in diverse settings.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) BREATHE
Disease(s) or condition(s) being studied Infections and Infestations,Respiratory
Sub-Disease(s) or condition(s) being studied Any form of hypoxemia
Purpose of the trial Treatment: Other
Anticipated trial start date 01/09/2023
Actual trial start date
Anticipated date of last follow up 30/11/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 424
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL https://clinicaltrials.gov/ct2/show/NCT05754034?term=riviello&draw=2&rank=1
Secondary Ids Issuing authority/Trial register
KHISERC00082023 KIJABE HOSPITAL INSTITUTIONAL SCIENTIFIC AND ETHICAL REVIEW COMMITTEE
NCT05754034 ClinicalTrial.gov
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 Stratified allocation where factors such as age, gender, center, or previous treatment are used in the stratification Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group PROTOCOLIZED STANDARD FLOW OXYGEN Study staff will titrate oxygen delivery devices (nasal cannula, facemask, nonrebreather mask) and flow in liters per minute as per the study SOP. The protocol SpO2 target is 90-94%. FOR THE DURATION OF HYPOXIA AND ADMISSION Commence standard flow oxygen as determined by randomization within 24 hours of admission and continue until discharge. Participants will be maintained on SFO protocols throughout their hospitalization, depending on their initial randomization. Per protocol, participants will be removed from oxygen support when they are no longer hypoxemic (ie, when SpO2 more than 90% without oxygen therapy). If hypoxemia returns, they will be placed back on SFO as had been determined by their initial randomization. If patients are deemed to need escalation to NIV or intubation by their clinical team, they will be escalated as per usual clinical care. When de-escalation is deemed possible by the clinical team, they will resume SFO as mandated by their initial randomization. 212 Active-Treatment of Control Group
Experimental Group protocolised High flow oxygen group Study staff will titrate oxygen therapy via the Airvo2 high flow nasal cannula device as per the study SOP. The principle of this titration is to maximize flow and minimize FiO2 with each titration. The goal is to reach the target SpO2 goal while conserving oxygen.High flow oxygen humidified and heated oxygen delivered at high flow rates via nasal cannula, with protocol to target SpO2 90-94% For the entire period of hypoxemia and admission Commence High Flow Oxygen (HFO) as determined by randomization within 24 hours of admission and continue until discharge. Participants will be maintained on HFO protocols throughout their hospitalization, depending on their initial randomization. Per protocol, participants will be removed from oxygen support when they are no longer hypoxemic (ie, when SpO2 equal to or greater than 90% without oxygen therapy). If hypoxemia returns, they will be placed back on HFO as determined by their initial randomization. If patients are deemed to need escalation to NIV or intubation by their clinical team, they will be escalated as per usual clinical care. When de-escalation is deemed possible by the clinical team, they will resume HFO as mandated by their initial randomization. 212
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
-age 18 years and above AND - admitted to a study site hospital within the 24 hours prior to screening AND - SpO2 less than 90% at time of first assessment OR - receiving oxygen at time of first assessment -imminent death (high clinical suspicion of death within 24 hours of admission) - patient or caregiver refusal of study participation - history of chronic respiratory failure (chronic SpO2 less than 90%) or chronic oxygen dependence for at least 3 months - anatomical factors precluding the use of nasal cannula - intubation or non-invasive ventilation by the clinical team prior to screening for the trial - known hypoxemia at transferring facility for more than 48 hours - lack of availability of either SFO or HFO devices or supplies at the time of randomization. 80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 120 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 29/05/2023 KIJABE HOSPITAL INSTITUTIONAL SCIENTIFIC AND ETHICAL REVIEW COMMITTE
Ethics Committee Address
Street address City Postal code Country
KIJABE NAIROBI 00220 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome In-hospital mortality At discharge
Secondary Outcome 1. 90-day mortality 2. 90-day functional status as measured by the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0). 72,73 3. Meeting objective criteria for need to escalate respiratory therapy to NIV or invasive ventilation 4. Escalating to NIV or invasive ventilation 5. Days requiring oxygen 6. Hospital length of stay 7. ICU length of stay At discharge and at 90 days post-discharge
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
AIC KIJABE HOSPITAL KIJABE HOSPITAL NAIROBI 00220 Kenya
NAKURU COUNTY TEACHING AND REFERRRAL HOSPITAL NAKURU-SIGOT ROAD NAKURU 20100 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
The Wellcome Trust Limited London UK 215 Euston Road London NW1 2BE United Kingdom
The Harvard Global Health Institute 42 Church St Boston United States of America
Fisher and Paykel 420 Cob Drive Northampton United Kingdom
Butterfly Network 1600 District Ave Burlington United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Beth Israel Deaconess Medical Center 330 Brookline Ave Boston United States of America University
COLLABORATORS
Name Street address City Postal code Country
Bethany Hedt Gauthier 330 Brookline Ave Boston United States of America
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Elisabeth Riviello eriviell@bidmc.harvard.edu 16174475131 330 Brookline Ave
City Postal code Country Position/Affiliation
Boston United States of America Principal Investigator
Role Name Email Phone Street address
Public Enquiries George Otieno georgeotieno2@gmail.com 254715512835 AIC KIJABE
City Postal code Country Position/Affiliation
Nairobi 00220 Kenya SITE PRINCIPAL INVESTIGATOR FOR KIJABE HOSPITAL
Role Name Email Phone Street address
Scientific Enquiries PETER ODUOR ODUORPR@GMAIL.COM 254722415335 NAKURU SIGOR ROAD
City Postal code Country Position/Affiliation
NAKURU Kenya SITE PRINCIPAL Investigator NAKURU LEVEL 6 HOSPITAL
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Yes As noted in the Key Access Criteria, access to IPD can be requested, and will be granted if the Key Access Criteria are met. Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Data requests can be submitted starting 12 months after main results article publication, and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis. Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and can be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). Only de-identified data will be shared.Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and can be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). Only de-identified data will be shared. Requests for data can be sent to: georgeotieno2@gmail.com or oduorpr@gmail.com
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