DRKS00027645RecruitingNot Applicable
Automatic oxygen control versus manual oxygen control in neonatal and pediatric patients with non-invasive ventilation - Auto-O2-Peds-NIV
Klinik für NeonatologieUniversitätsmedizin Mannheim0 sites40 target enrollmentStarted: February 17, 2022Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 40
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized controlled study
- Masking
- Open (masking not used)
Eligibility Criteria
- Ages
- 37 Pregnancy to 18 Years (—)
- Sex
- All
Inclusion Criteria
- •non-invasive ventilation and FiO2>0.3
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
Investigators
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