Skip to main content
OpenTrials
Completed

NCT Number: NCT05274386

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Neonatal Respiratory Distress Lung Diseases Pulmonary Atelectasis Respiratory Tract Diseases Very Low Birth Weight Infant

Age range

2 week and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Motol University Hospital

Prague, 15500, Czechia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fabian ventilator with PRICO system (Acutronic Medical Systems AG, Hirzel, Switzerland); SpO2 averaging time set to 4to6 s

Device

The SpO2 averaging time will be set to 4to6 s for the next 12 hours.

Fabian ventilator with PRICO system (Acutronic Medical Systems AG, Hirzel, Switzerland); SpO2 averaging time set to 10 s

Device

The SpO2 averaging time will be set to 10 s for the next 12 hours.

Fabian ventilator with PRICO system (Acutronic Medical Systems AG, Hirzel, Switzerland); SpO2 averaging time set to 16 s

Device

The SpO2 averaging time will be set to 16 s for the next 12 hours.

Primary outcomes

  1. Percent time in SpO2 target range

    Time frame: 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 outcomes

  1. 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%.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Czech Technical University in Prague

Other

Collaborators

  • Motol University Hospital

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Mar 10, 2022
Registry last updated
Mar 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.