J96.0
Conditions
Interventions
Group 1: Patients with non-invasive ventilation and manual oxygen control
Group 2: Patients with non-invasive ventilation and automated oxygen control
Sponsors
Klinik für NeonatologieUniversitätsmedizin Mannheim
Eligibility
Sex/Gender
All
Age
No minimum to 18 Years
Inclusion criteria
Inclusion criteria: non-invasive ventilation and FiO2>0.3
Exclusion criteria
Exclusion criteria: SpO2 targets outside the range in protocol (clinical decision e.g. in pulmonary hypertension)) - Preterm infants (gestational age < 37 weeks) - Chronic or acute dyshemoglobinemia: acute CO poisoning, methhemoglobin, sickle cell disease - Cyanotic heart disease - Lack of Echocardiography - Patient not on the same type of respiratory support during the total study period (8 h in non-invasive ventilation) - Lack of parental consent - Lack of patient consent (appropriate for age) - Lack of device enabling closed loop oxygen control before inclusion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and efficacy of closed loop oxygen control (CLOX) in PICU / NICU patients with need of supplemental oxygen for more than 8 hours on non-invasive ventilation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Comparison of CLOX performance in different age groups and different lung conditions during non-invasive ventilation. | — |
Countries
Germany
Contacts
Public ContactSüha Demirakca
Klinik für NeonatologieUniversitätsmedizin Mannheim
Outcome results
None listed