Evaluation of the Safety and Tolerability of the ‘LeVe CPAP Flow Generator’ in Healthy Volunteers at Mengo Hospital in Kampala Uganda

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

PACTR

Registry ID

PACTR202105734146484

Enrollment

Registered

2021-05-24

Start date

2021-03-15

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory

Interventions

CPAP

Baseline

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Staff members at Mengo Hospital Age 20-50 years

Exclusion criteria

Exclusion criteria: Current or ex-smoker Underlying respiratory conditions BMI >30 Any contraindications from previous use of CPAP or oxygen therapy.

Design outcomes

Primary

Measure	Time frame
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.	—

Secondary

Measure	Time frame
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	—

Countries

Uganda

Contacts

Public ContactPeter Clumer

Associate Professor

P.R.Culmer@leeds.ac.uk441133432141

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Aug 9, 2026