NCT06207994

PRICO: OPTI Target Range

Evaluation of the Impact of a Narrower SpO2 Target Range on Performance of an Automatic FiO2 Control System: a Randomized Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• 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 if a narrower SpO2 Target Range setting automated control of FiO2 (A-FiO2) is more effective than a wider SpO2 Target Range

Detailed description

A-FiO2 systems have consistently proven to be more effective than manual control. Because it is more precise than manual control, studies of some A-FiO2 systems found small differences in the set target range (shift in the median and width) can optimize the relative performance. Similar studies of the A-FiO2 system (PRICO) used in the investigator's NICU have not been conducted. The standard of practice in the investigator's NICU is to use 4 different target ranges to balance the risk of hypoxia and hyperoxia based on the gestational age vulnerabilities. Based on the studies of other A-FiO2 systems the investigators believe a slightly narrower width target range would be more effective. Therefore, a small systematic study is needed to determine the optimal set target range to achieve the therapeutic goal.

Conditions

• Neonatal Respiratory Distress
• Very Low Birth Weight Infant

Interventions

Type	Name	Description
DEVICE	Narrow TR	The width of the PRICO SpO2 TR is set to 3% SpO2.
DEVICE	Shifted TR	The lower and the upper limits of the PRICO SpO2 TR are increased by 1% SpO2.

Timeline

• Start date: 2024-02-20
• Primary completion: 2025-09-01
• Completion: 2025-09-01
• First posted: 2024-01-17
• Last updated: 2025-03-25

Locations

1 site across 1 country: Czechia