Neonatal Respiratory Distress, Very Low Birth Weight Infant
Conditions
Keywords
SpO2 averaging time, pulse oximetry, automatic oxygen control
Brief summary
The aim of the study is to determine the preferred oximeter averaging setting during automated control of FiO2 (A-FiO2) in infants receiving respiratory support and supplemental oxygen.
Detailed description
There are 7 different averaging time settings available with PRICO (Acutronic Medical Systems AG, Hirzel, Switzerland), but after over a year of experience there is no clear clinical impression of the best setting. Therefore, a small systematic study is needed to determine the optimal guidelines.
Interventions
DEVICEFabian ventilator with PRICO system (Acutronic Medical Systems AG, Hirzel, Switzerland); SpO2 averaging time set to 4to6 s
The SpO2 averaging time will be set to 4to6 s for the next 12 hours.
DEVICEFabian ventilator with PRICO system (Acutronic Medical Systems AG, Hirzel, Switzerland); SpO2 averaging time set to 10 s
The SpO2 averaging time will be set to 10 s for the next 12 hours.
DEVICEFabian ventilator with PRICO system (Acutronic Medical Systems AG, Hirzel, Switzerland); SpO2 averaging time set to 16 s
The SpO2 averaging time will be set to 16 s for the next 12 hours.
Sponsors
Motol University Hospital
Czech Technical University in Prague
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Intervention model description
Subjects will be switched between 3 averaging times (4to6s-10s-16s) every 12 hours. The sequence will be assigned in random order. Each enrolled subject will continue in the study with regular changes in averaging time through the course of their need for A-FiO2.
Eligibility
Sex/Gender
ALL
Age
2 Weeks to No maximum
Healthy volunteers
No
Inclusion criteria
* All VLBW on respiratory support and oxygen requirements after 2 weeks of age in the NICU are eligible after parental informed consent is obtained.
Exclusion criteria
* Parental informed consent is not obtained * Recording device for automated control of FiO2 is not available
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent time in SpO2 target range | 20 days of intervention on average | Percent time in the intended SpO2 target range (compliance), at SpO2 \<86% (safety), and at SpO2 \>98% (safety). Period with SpO2 higher than the target range with FiO2 =0.21 will be included in the target range compliance and excluded from time above the target range. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effect of set SpO2 target range and mode of ventilation on the percent time in SpO2 target range, at SpO2 <86%, and at SpO2 >98%. | 20 days of intervention on average | A general linear model will be used controlling for target range (based on gestational age), mode of ventilation (e.g. High-frequency oscillatory ventilation, Continuous mandatory ventilation, Continuous positive airway pressure, High-flow nasal cannula, and Nasal intermittent positive pressure ventilation), and subject. |
Countries
Czechia
Outcome results
None listed