Evaluation of the Impact of SpO2 Averaging Time on Performance of an Automatic FiO2 Control System: a Randomized Study

NCT05274386 | Completed

• 1 other identifier: PricoOptisatAvg
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to determine the preferred oximeter averaging setting during automated control of FiO2 (A-FiO2) in infants receiving respiratory support and supplemental oxygen.

Conditions

Neonatal Respiratory Distress; Very Low Birth Weight Infant

Keywords

SpO2 averaging time; pulse oximetry; automatic oxygen control

Outcome Measures

Primary Outcomes (1)

• Percent time in SpO2 target range

  Percent time in the intended SpO2 target range (compliance), at SpO2 \<86% (safety), and at SpO2 \>98% (safety). Period with SpO2 higher than the target range with FiO2 =0.21 will be included in the target range compliance and excluded from time above the target range.

  20 days of intervention on average

Secondary Outcomes (1)

• Effect of set SpO2 target range and mode of ventilation on the percent time in SpO2 target range, at SpO2 <86%, and at SpO2 >98%.

  20 days of intervention on average

Study Arms (3)

Averaging time 4to6 s

OTHER

The SpO2 averaging time will be set to 4to6 s for the next 12 hours. All elements of care will be as routinely used, except the changing of the averaging time setting.

Device: Fabian ventilator with PRICO system (Acutronic Medical Systems AG, Hirzel, Switzerland); SpO2 averaging time set to 4to6 s

Averaging time 10 s

OTHER

The SpO2 averaging time will be set to 10 s for the next 12 hours. All elements of care will be as routinely used, except the changing of the averaging time setting.

Device: Fabian ventilator with PRICO system (Acutronic Medical Systems AG, Hirzel, Switzerland); SpO2 averaging time set to 10 s

Averaging time 16 s

OTHER

The SpO2 averaging time will be set to 16 s for the next 12 hours. All elements of care will be as routinely used, except the changing of the averaging time setting.

Device: Fabian ventilator with PRICO system (Acutronic Medical Systems AG, Hirzel, Switzerland); SpO2 averaging time set to 16 s

Interventions

Fabian ventilator with PRICO system (Acutronic Medical Systems AG, Hirzel, Switzerland); SpO2 averaging time set to 4to6 s DEVICE

The SpO2 averaging time will be set to 4to6 s for the next 12 hours.

Averaging time 4to6 s

Fabian ventilator with PRICO system (Acutronic Medical Systems AG, Hirzel, Switzerland); SpO2 averaging time set to 10 s DEVICE

The SpO2 averaging time will be set to 10 s for the next 12 hours.

Averaging time 10 s

Fabian ventilator with PRICO system (Acutronic Medical Systems AG, Hirzel, Switzerland); SpO2 averaging time set to 16 s DEVICE

The SpO2 averaging time will be set to 16 s for the next 12 hours.

Averaging time 16 s

Eligibility Criteria

• Age: 2 Weeks+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Parental informed consent is not obtained
• Recording device for automated control of FiO2 is not available

Sponsors & Collaborators

• Czech Technical University in Prague: lead
• Motol University Hospital: collaborator

Study Sites (1)

Motol University Hospital

Prague, 15500, Czechia

Location

MeSH Terms

Conditions

Pulmonary Atelectasis

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Study Officials

• Jan Janota, PhD

  Motol University Hospital

  PRINCIPAL INVESTIGATOR

• Thomas E Bachman, MSc

  Czech Technical University in Prague

  PRINCIPAL INVESTIGATOR

• Veronika Rafl-Huttova, MSc

  Czech Technical University in Prague

  PRINCIPAL INVESTIGATOR

• Jakub Rafl, PhD

  Czech Technical University in Prague

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Subjects will be switched between 3 averaging times (4to6s-10s-16s) every 12 hours. The sequence will be assigned in random order. Each enrolled subject will continue in the study with regular changes in averaging time through the course of their need for A-FiO2.

Study Record Dates

• First Submitted: February 14, 2022
• First Posted: March 10, 2022
• Study Start: February 17, 2022
• Primary Completion: December 30, 2022
• Study Completion: December 30, 2022
• Last Updated: March 25, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share

Locations

CZ (1)