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

Not Applicable

Completed

• Conditions: Very Low Birth Weight Infant; Neonatal Respiratory Distress
• Interventions: Device: Fabian ventilator with PRICO system (Acutronic Medical Systems AG, Hirzel, Switzerland); SpO2 averaging time set to 16 s; Device: Fabian ventilator with PRICO system (Acutronic Medical Systems AG, Hirzel, Switzerland); SpO2 averaging time set to 4to6 s; Device: Fabian ventilator with PRICO system (Acutronic Medical Systems AG, Hirzel, Switzerland); SpO2 averaging time set to 10 s

• Registration Number: NCT05274386
• Lead Sponsor: Czech Technical University in Prague

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.

Study Timeline

• Study First Submitted: 2022-02-14
• Study Start: 2022-02-17
• Study First Submitted QC: 2022-03-01
• Study First Posted: 2022-03-10
• Primary Completion: 2022-12-30
• Study Completion: 2022-12-30
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-24
• Last Update Posted: 2025-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Averaging time 16 s	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. All elements of care will be as routinely used, except the changing of the averaging time setting.
Averaging time 4to6 s	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. All elements of care will be as routinely used, except the changing of the averaging time setting.
Averaging time 10 s	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. All elements of care will be as routinely used, except the changing of the averaging time setting.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Motol University Hospital; 🇨🇿 Prague, Czechia