RedVent2021

Safety and Performance Evaluation of Locally made Mechanical ventilator in Ethiopia, Single-arm open-label study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

PACTR

Registry ID

PACTR202311877094703

Enrollment

Registered

2023-11-09

Start date

2021-09-08

Completion date

Unknown

Last updated

2026-01-27

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

Conditions

Respiratory

Interventions

Mechanical ventilator

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: • Female participants who is pregnant • Patients with hypotension MAP9 • Not willing to give consent • Patients with ARDS

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

—

Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Countries

Ethiopia

Contacts

Public ContactAddamu Kiltu

Armauer Hansen Research Institute

addis.alemu@ahri.gov.et+251929041898

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Feb 4, 2026