PRICO: OPTI Target Range

Last updated: March 24, 2025
Sponsor: Czech Technical University in Prague
Overall Status: Active - Recruiting

Phase

N/A

Condition

Lung Injury

Respiratory Failure

Treatment

Narrow TR

Shifted TR

Clinical Study ID

NCT06207994
PricoOptiTR
  • Ages > 2
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • All VLBW on respiratory support and oxygen requirements after 2 weeks of age in theNICU are eligible after informed consent is obtained.

Exclusion

Exclusion Criteria:

  • Informed consent is not obtained

  • Recording device for automated control of FiO2 is not available

Study Design

Total Participants: 10
Treatment Group(s): 2
Primary Treatment: Narrow TR
Phase:
Study Start date:
February 20, 2024
Estimated Completion Date:
September 30, 2025

Study 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.

Connect with a study center

  • Motol University Hospital

    Prague, 15500
    Czechia

    Active - Recruiting

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