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Automatic oxygen control versus manual oxygen control in neonatal and pediatric patients with invasive ventilation

Automatic oxygen control versus manual oxygen control in neonatal and pediatric patients with invasive ventilation - Auto-O2-Peds-Invasive

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00027647
Enrollment
40
Registered
2022-02-16
Start date
2022-02-17
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 invasive mechanical ventilation and manual oxygen control Group 2: Patients with invasive mechanical ventilation 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: invasive mechanical 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 (48 h in 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

MeasureTime frame
Safety and efficacy of closed loop oxygen control (CLOX) in PICU / NICU patients with need of supplemental oxygen for more than 48 hours on invasive mechanical ventilation.

Secondary

MeasureTime frame
Comparison of CLOX performance in different age groups and different lung conditions during invasive ventilation.

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