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Automatic oxygen control versus manual oxygen control in neonatal and pediatric patients during high-flow oxygen therapy

Automatic oxygen control versus manual oxygen control in neonatal and pediatric patients during high-flow oxygen therapy - Auto-O2-Peds-HF

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00025959
Enrollment
40
Registered
2022-01-13
Start date
2021-07-25
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

J96.0

Interventions

Group 1: Patients with High Flow Oxygen Therapy and manual oxygen control Group 2: Patients with High flow oxygen therapy and automated oxygen control

Sponsors

Klinik für NeonatologieUniversitätsmedizin Mannheim
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 18 Years

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

MeasureTime 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

MeasureTime frame
Comparison of CLOX performance in different age groups and different lung conditions during high-flow-oxygen therapy.

Countries

Germany

Contacts

Public ContactSüha Demirakca

Klinik für NeonatologieUniversitätsmedizin Mannheim

Sueha.Demirakca@umm.de0621-383 3510

Outcome results

None listed

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