J96.0
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: - Type of respiratory support: - High Flow Oxygen Therapy - FiO2 > 0.30
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 (8h on HFNT) - 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 high-flow-therapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| Comparison of CLOX performance in different age groups and different lung conditions during high-flow-oxygen therapy. | — |
Countries
Germany
Contacts
Klinik für NeonatologieUniversitätsmedizin Mannheim