Automatic oxygen control versus manual oxygen control in neonatal and pediatric patients with non-invasive ventilatio

Recruiting

• Conditions: J96.0; Acute respiratory failure

• Registration Number: DRKS00027645
• Lead Sponsor: Klinik für NeonatologieUniversitätsmedizin Mannheim

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-17
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Comparison of CLOX performance in different age groups and different lung conditions during non-invasive ventilation.