PRICO: OPTI Target Range

N/ARecruitingNCT06207994

Czech Technical University in Prague10 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Neonatal Respiratory Distress Very Low Birth Weight Infant

Interventions

Narrow TRDEVICE

The width of the PRICO SpO2 TR is set to 3% SpO2.

Shifted TRDEVICE

The lower and the upper limits of the PRICO SpO2 TR are increased by 1% SpO2.

Eligibility

Sex: ALLMin age: 2 Weeks

Medical Language ↔ Plain English

Inclusion Criteria: * All VLBW on respiratory support and oxygen requirements after 2 weeks of age in the NICU are eligible after informed consent is obtained. Exclusion Criteria: * Informed consent is not obtained * Recording device for automated control of FiO2 is not available

Locations (1)

Motol University Hospital

Prague, Czechia

RECRUITING

Outcomes

Primary Outcomes

Percent time in the set SpO2 target range

Percent time in the set SpO2 target range (compliance). Periods with SpO2 higher than the target range with FiO2 = 0.21 will be included in the target range compliance.

Time frame: 30 days of intervention if possible

Percent time at SpO2 ≤80% and >98%

Percent time at SpO2 ≤80% and \>98% (safety). Periods with SpO2 higher than 98% with FiO2 = 0.21 will be excluded.

Time frame: 30 days of intervention if possible

Secondary Outcomes

Percent time above the set SpO2 target range

Percent time above the set SpO2 target range. Periods with SpO2 higher than the target range with FiO2 = 0.21 will be excluded from time above the target range.

Time frame: 30 days of intervention if possible

Percent time below the set SpO2 target range

Percent time below the set SpO2 target range.

Time frame: 30 days of intervention if possible

Central Contacts

Jakub Rafl, PhD

CONTACT

+420728229991 rafl@fbmi.cvut.cz

Data from ClinicalTrials.gov

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