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.: PACTR202105734146484 Date of Approval: 24/05/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Evaluation of the Safety and Tolerability of the ‘LeVe CPAP Flow Generator’ in Healthy Volunteers at Mengo Hospital in Kampala Uganda
Official scientific title Evaluation of the Safety and Tolerability of the ‘LeVe CPAP Flow Generator’ in Healthy Volunteers at Mengo Hospital in Kampala Uganda
Brief summary describing the background and objectives of the trial Research done globally so far indicates that during the COVID-19 pandemic non-invasive ventilation has been crucial in the treatment of patients with moderate to severe symptoms, reducing the need for invasive ventilation and intensive care admission. Oxygen enriched continuous positive airway pressure (CPAP) has also been demonstrated as a suitable treatment for other respiratory diseases, such as pneumonia. However, existing ventilators systems are not designed for cost and resource efficiency which may preclude their use in resource-limited contexts. To address this problem, The ‘LeVe CPAP Flow Generator’ has been developed to be fit for purpose in resource poor settings with a range of oxygen sources including oxygen concentrators to address these challenges. The purpose of this pilot study is to validate the safety of the LeVe system in healthy volunteers, prior to further studies that will explore its clinical efficacy for different respiratory diseases (e.g. COVID-19, pneumonia) and in different patient groups (adult and neonatal care). Objective of the study is to determine the safety, tolerability and acceptability of the LeVe CPAP Flow Generator’ among healthy volunteers and to ensure they do not cause harm. This is designed as a limited pilot study, recruiting from a population of healthy volunteers at a single-site (Mengo Hospital) to conduct an assessment of safety of the LeVe CPAP system
Type of trial CCT
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 15/03/2021
Actual trial start date 15/03/2021
Anticipated date of last follow up 22/03/2021
Actual Last follow-up date 22/03/2021
Anticipated target sample size (number of participants) 20
Actual target sample size (number of participants) 20
Recruitment status Completed
Publication URL 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 Non-randomised 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
Experimental Group CPAP CPAP will be provided between 7.5 cm/H20 and 12.5 cm/H20 Oxygen enrichment will be applied using piped medical oxygen entrained at 5L/min (providing an approximate FiO2 of 40-50%). 30 minutes The participant will arrive; understanding and consent will be confirmed. The participant will have their oxygen saturations checked with a pulse oximeter and end tidal carbon dioxide will be measured via the exhaled gas of the subject using End Tidal carbon dioxide (ETCO2) sensor. The participant will use the LeVe CPAP Flow Generator for 10 minutes. The system will use the following configuration: Oxygen enrichment will be applied using piped medical oxygen entrained at 5L/min (providing an approximate FiO2 of 40-50%). Oxygen saturations will be monitored continuously with a pulse oximeter. End tidal Carbon dioxide levels will be measured continuously ETCO2 sensor. These figures will be recorded anonymously in a spreadsheet. The participant may be asked to breath with a high respiratory rate to simulate respiratory distress during evaluation. If any patient develops hypoxia (Sa02 <94%) or hypercapnia (ETC02 >5.7KPa) the Flow Generator system will be stopped and taken off the breathing circuit and the evaluation will be put on hold. 10
Control Group Baseline No intervention is made in this control group. The aim is to obtain baseline readings for oxygen saturations and end tidal carbon dioxide levels, prior to the CPAP intervention group. 5 minutes The participant will arrive; understanding and consent will be confirmed. The participant will be seated, breath naturally and have their oxygen saturations checked with a pulse oximeter and end tidal carbon dioxide will be measured via the exhaled gas of the subject using End Tidal carbon dioxide (ETCO2) sensor. These baseline figures will be recorded anonymously in a spreadsheet. 10 Dose Comparison
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Staff members at Mengo Hospital Age 20-50 years Current or ex-smoker Underlying respiratory conditions BMI >30 Any contraindications from previous use of CPAP or oxygen therapy. Adult: 19 Year-44 Year 20 Year(s) 50 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 31/01/2021 Mengo Hospital Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Mengo Hospital, Kampala, Uganda. Kampala n/a Uganda
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Can the LeVe CPAP Flow Generator be used safely without inducing hypoxia or carbon dioxide retention? Oxygen saturations will be monitored continuously with a pulse oximeter. End tidal Carbon dioxide levels will be measured continuously ETCO2 sensor. These figures will be recorded anonymously. Oxygen Saturations measured as the flow and pressure of gases in the system during trial use. Baseline on room air, at 7.5, 10, 12.5 cmH20
Secondary Outcome Is the LeVe CPAP Flow Generator well tolerated by users? The participant will be given a separate questionnaire to fill out on the user tolerability of using the LeVe CPAP Flow Generator. This will determine 1. Tolerability of using the system 2. Acceptability of using the system At the end of thee 30 minutes
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mengo Hospital 169 Sir Albert Cook Road Kampala o256 Uganda
FUNDING SOURCES
Name of source Street address City Postal code Country
University of Leeds. Global Challenge Research Fund GCRF University of Leeds, Woodhouse Lane Leeds LS2 9JT United Kingdom
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mengo Hospital 169 Sir Albert Cook Road, Mengo Kampala PO Box 71 Uganda Hospital
Secondary Sponsor University of Leeds Woodhouse Road Leeds LS29JT United Kingdom University
COLLABORATORS
Name Street address City Postal code Country
Medical Aid International Firs Farm, Stagsden Bedfordshire MK43 8TB United Kingdom
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Edith Namulema edith.namulema@mengohospital.org 256772460792 169 Sir Albert Cook Road
City Postal code Country Position/Affiliation
Kampala 0256 Uganda Medical Doctor
Role Name Email Phone Street address
Public Enquiries Peter Clumer P.R.Culmer@leeds.ac.uk 441133432141 School of Mechanical Engineering
City Postal code Country Position/Affiliation
Leeds LS29JT United Kingdom Associate Professor
Role Name Email Phone Street address
Scientific Enquiries Nik Kapur N.Kapur@leeds.ac.uk 01133432152 School of Mechanical Engineering
City Postal code Country Position/Affiliation
Leeds LS29JT United Kingdom Professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data collected during the trial after de identification will be shared. The study protocol statistical analysis plan analytical codes and the informed consent will be available for review Data will be available 12 months following publication from the University of Leeds. Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol 2 years from date of study IPD and Results available on request from the investigators at the University of Leeds.
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