NCT05274386

Evaluation of the Impact of SpO2 Averaging Time on Performance of an Automatic FiO2 Control System: a Randomized Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Czech Technical University in Prague · Academic / Other
• Sex: All
• Age: 2 Weeks
• Healthy volunteers: Not accepted

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.

Conditions

• Neonatal Respiratory Distress
• Very Low Birth Weight Infant

Interventions

Type	Name	Description
DEVICE	Fabian 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.
DEVICE	Fabian 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.
DEVICE	Fabian 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.

Timeline

• Start date: 2022-02-17
• Primary completion: 2022-12-30
• Completion: 2022-12-30
• First posted: 2022-03-10
• Last updated: 2025-03-25

Locations

1 site across 1 country: Czechia