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

Very Low Birth Weight Infant Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05274386
• Other study ID #: PricoOptisatAvg
• Status: Recruiting
• Phase: N/A
• Start date: February 17, 2022
• Est. completion date: September 2022

Study information

• Verified date: March 2022
• Source: Czech Technical University in Prague
• Contact: Jakub Rafl, PhD
• Phone: +420728229991
• Email: rafl[@]fbmi.cvut.cz
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: September 2022
• Est. primary completion date: September 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Birth Weight
• Neonatal Respiratory Distress
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn
• Very Low Birth Weight Infant

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Czechia	Motol University Hospital	Prague

Sponsors (2)

Lead Sponsor	Collaborator
Czech Technical University in Prague	Motol University Hospital, Prague

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent time in SpO2 target range	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.	20 days of intervention on average
Secondary	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%.	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.	20 days of intervention on average