PRICO: OPTI Target Range (POSTR)

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

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

Study Overview

• Status: Recruiting
• Conditions: Neonatal Respiratory Distress; Very Low Birth Weight Infant
• Intervention / Treatment: Device: Narrow TR; Device: Shifted TR

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.

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jakub Rafl, PhD; Phone Number: +420728229991; Email: rafl@fbmi.cvut.cz

Study Locations

• Czechia
  • Prague, Czechia, 15500
    • Recruiting
    • Motol University Hospital
    • Contact: Jan Janota, PhD; Email: jan.janota@fnmotol.cz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard Target Range; The SpO2 TR width is set to 5% SpO2, as is routine in the department. The actual TR will vary depending on the GA, as is standard practice in the department.
Experimental: Narrow Target Range; The SpO2 TR width is set narrower than the Standard TR. The actual TR will vary depending on the GA, as is standard practice in the department.	Device: Narrow TR; The width of the PRICO SpO2 TR is set to 3% SpO2.
Experimental: Shifted Target Range; The SpO2 TR width is set as the Standard TR. The median of the TR is shifted up compared to the Standard TR. The actual TR will vary depending on the GA, as is standard practice in the department.	Device: Shifted TR; The lower and the upper limits of the PRICO SpO2 TR are increased by 1% SpO2.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	30 days of intervention if possible

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	30 days of intervention if possible
Percent time below the set SpO2 target range	Percent time below the set SpO2 target range.	30 days of intervention if possible

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Associated effects	Effects associated with the mode of ventilation and set SpO2 control (based on gestational age) will be explored. The effects will be treated as covariables in a multivariate linear regression model with SpO2 target range compliance as a dependent variable.	30 days of intervention if possible
Stability	Effects associated with infant stability will be explored. The stability will be assessed based on the mean time in the SpO2 target range.	30 days of intervention if possible

Collaborators and Investigators

• Sponsor: Czech Technical University in Prague
• Collaborators: University Hospital, Motol
• Investigators: Principal Investigator: Thomas E Bachman, MSc, Czech Technical University in Prague; Principal Investigator: Ekaterina Orlova, MD, Motol University Hospital Prague, Neonatal Unit; Principal Investigator: Jan Janota, MD, PhD, Motol University Hospital Prague, Neonatal Unit; Principal Investigator: Jana Dornakova, MD, Motol University Hospital Prague, Neonatal Unit

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2024
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): October 1, 2024

Study Registration Dates

• First Submitted: December 18, 2023
• First Submitted That Met QC Criteria: January 4, 2024
• First Posted (Actual): January 17, 2024

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 26, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: pulse oximetry; automatic oxygen control; SpO2 Target Range
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Infant, Newborn, Diseases; Body Weight; Infant, Premature, Diseases; Birth Weight; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn
• Other Study ID Numbers: PricoOptiTR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The IPD will be made available upon reasonable request in a deidentified, HIPAA-compliant form.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No