Clinical trial NCT06207994: PRICO: OPTI Target Range
Official title: Evaluation of the Impact of a Narrower SpO2 Target Range on Performance of an Automatic FiO2 Control System: a Randomized Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neonatal Respiratory Distress
Very Low Birth Weight Infant
Keywords: SpO2 Target Range
pulse oximetry
automatic oxygen control
Lead sponsor: Czech Technical University in Prague
Sponsor class: OTHER
Collaborators: name: University Hospital, Motol
First posted: 2024-01-17
Enrollment: 10
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Subjects will be switched between the standard target range, the narrow target range, and the target range with a higher median every 12 hours. The sequence will be randomized differently for each subject, with a balanced block design such that every 3 days each range is evaluated twice.

Once enrolled, each subject will continue in the study with regular changes in averaging time through the course of their need for A-FiO2 or 30 days, whichever is shorter. All other elements of care will be as routinely used.
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Percent time in the set SpO2 target range
timeFrame: 30 days of intervention if possible
measure: Percent time at SpO2 ≤80% and >98%
timeFrame: 30 days of intervention if possible
Secondary outcomes:
measure: Percent time above the set SpO2 target range
timeFrame: 30 days of intervention if possible
measure: Percent time below the set SpO2 target range
timeFrame: 30 days of intervention if possible
Other outcomes:
measure: Associated effects
timeFrame: 30 days of intervention if possible
measure: Stability
timeFrame: 30 days of intervention if possible
Locations:
city: Prague
country: Czechia
facility: Motol University Hospital
Study officials:
affiliation: Motol University Hospital Prague, Neonatal Unit
name: Ekaterina Orlova, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Motol University Hospital Prague, Neonatal Unit
name: Jan Janota, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Czech Technical University in Prague
name: Thomas E Bachman, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Motol University Hospital Prague, Neonatal Unit
name: Jana Dornakova, MD
role: PRINCIPAL_INVESTIGATOR
References: