Neonatal Respiratory DistressNCT05274386
Evaluation of the Impact of SpO2 Averaging Time on Performance of an Automatic FiO2 Control System: a Randomized Study
A study testing Fabian ventilator with PRICO system (Acutronic Medical Systems AG, Hirzel, Switzerland); SpO2 averaging time set to 4to6 s, Fabian ventilator with PRICO system (Acutronic Medical Systems AG, Hirzel, Switzerland); SpO2 averaging time set to 10 s and Fabian ventilator with PRICO system (Acutronic Medical Systems AG, Hirzel, Switzerland); SpO2 averaging time set to 16 s in people with Neonatal Respiratory Distress and Very Low Birth Weight Infant, run by Czech Technical University in Prague at 1 site in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 weeks and older
- Conditions the study is for
- Neonatal Respiratory Distress, Very Low Birth Weight Infant
- What is being tested?
- Fabian ventilator with PRICO system (Acutronic Medical Systems AG, Hirzel, Switzerland); SpO2 averaging time set to 4to6 s, Fabian ventilator with PRICO system (Acutronic Medical Systems AG, Hirzel, Switzerland); SpO2 averaging time set to 10 s and Fabian ventilator with PRICO system (Acutronic Medical Systems AG, Hirzel, Switzerland); SpO2 averaging time set to 16 s
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCzechia
- Study dates
- 17 Feb 2022to 30 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 weeks and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All VLBW on respiratory support and oxygen requirements after 2 weeks of age in the NICU are eligible after parental informed consent is obtained.
Who cannot join
- Parental informed consent is not obtained
- Recording device for automated control of FiO2 is not available
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
There are 7 different averaging time settings available with PRICO (Acutronic Medical Systems AG, Hirzel, Switzerland), but after over a year of experience there is no clear clinical impression of the best setting. Therefore, a small systematic study is needed to determine the optimal guidelines.
- Being tested
- Fabian ventilator with PRICO system (Acutronic Medical Systems AG, Hirzel, Switzerland); SpO2 averaging time set to 4to6 s, Fabian ventilator with PRICO system (Acutronic Medical Systems AG, Hirzel, Switzerland); SpO2 averaging time set to 10 s, Fabian ventilator with PRICO system (Acutronic Medical Systems AG, Hirzel, Switzerland); SpO2 averaging time set to 16 s
- Keywords
- SpO2 averaging time, pulse oximetry, automatic oxygen control
- Medical subject headings
- Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fabian ventilator with PRICO system (Acutronic Medical Systems AG, Hirzel, Switzerland); SpO2 averaging time set to 4to6 sDevice
The SpO2 averaging time will be set to 4to6 s for the next 12 hours.
Fabian ventilator with PRICO system (Acutronic Medical Systems AG, Hirzel, Switzerland); SpO2 averaging time set to 10 sDevice
The SpO2 averaging time will be set to 10 s for the next 12 hours.
Fabian ventilator with PRICO system (Acutronic Medical Systems AG, Hirzel, Switzerland); SpO2 averaging time set to 16 sDevice
The SpO2 averaging time will be set to 16 s for the next 12 hours.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Device: Fabian ventilator with PRICO system (Acutronic Medical Systems AG, Hirzel, Switzerland); SpO2 averaging time set to 16 s |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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%.
A general linear model will be used controlling for target range (based on gestational age), mode of ventilation (e.g. High-frequency oscillatory ventilation, Continuous mandatory ventilation, Continuous positive airway pressure, High-flow nasal cannula, and Nasal intermittent positive pressure ventilation), and subject.
Measured: 20 days of intervention on average
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2022
- Study start17 Feb 2022
- Primary completion30 Dec 2022
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal Respiratory DistressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Czech Technical University in Prague
- Sponsor type
- University, hospital or other
- Collaborators
- Motol University Hospital
- Responsible party
- Sponsor
- Investigators
- Jan Janota, PhD, Principal investigator, Motol University HospitalThomas E Bachman, MSc, Principal investigator, Czech Technical University in PragueVeronika Rafl-Huttova, MSc, Principal investigator, Czech Technical University in PragueJakub Rafl, PhD, Principal investigator, Czech Technical University in Prague
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05274386
- Sponsor's protocol ID
- PricoOptisatAvg
- Status last verified
- Mar 2025
- First submitted
- 14 Feb 2022
- Last updated
- 25 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be available upon reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Impact of SpO2 Averaging Time on Performance of an Automatic FiO2 Control System: a Randomized Study
- ClinicalTrials.gov ID
- NCT05274386
- Acronym / sponsor ID
- PricoOptisatAvg
- Keywords
- SpO2 averaging time, pulse oximetry, automatic oxygen control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Czech Technical University in PragueUniversity, hospital or other
- Collaborators
- Motol University Hospital
- Study start
- 17 Feb 2022 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 10 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
There are 7 different averaging time settings available with PRICO (Acutronic Medical Systems AG, Hirzel, Switzerland), but after over a year of experience there is no clear clinical impression of the best setting. Therefore, a small systematic study is needed to determine the optimal guidelines.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Averaging time 4to6 s | Other | Device: Fabian ventilator with PRICO system (Acutronic Medical Systems AG, Hirzel, Switzerland); SpO2 averaging time set to 4to6 sThe 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. |
| Averaging time 10 s | Other | Device: Fabian ventilator with PRICO system (Acutronic Medical Systems AG, Hirzel, Switzerland); SpO2 averaging time set to 10 sThe 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. |
| Averaging time 16 s | Other | Device: Fabian ventilator with PRICO system (Acutronic Medical Systems AG, Hirzel, Switzerland); SpO2 averaging time set to 16 sThe 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. |
Who may qualify
- Ages
- 2 weeks and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All VLBW on respiratory support and oxygen requirements after 2 weeks of age in the NICU are eligible after parental informed consent is obtained.
Key exclusion criteria (2 listed)
- Parental informed consent is not obtained
- Recording device for automated control of FiO2 is not available
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fabian ventilator with PRICO system (Acutronic Medical Systems AG, Hirzel, Switzerland); SpO2 averaging time set to 4to6 sThe SpO2 averaging time will be set to 4to6 s for the next 12 hours. | Device | Averaging time 4to6 s |
| Fabian ventilator with PRICO system (Acutronic Medical Systems AG, Hirzel, Switzerland); SpO2 averaging time set to 10 sThe SpO2 averaging time will be set to 10 s for the next 12 hours. | Device | Averaging time 10 s |
| Fabian ventilator with PRICO system (Acutronic Medical Systems AG, Hirzel, Switzerland); SpO2 averaging time set to 16 sThe SpO2 averaging time will be set to 16 s for the next 12 hours. | Device | Averaging time 16 s |
Primary outcome
Percent time in SpO2 target range
Time frame: 20 days of intervention on average
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.
1 secondary outcome
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%.
Time frame: 20 days of intervention on average
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2025.
- Individual participant dataSharing planned: Yes. IPD will be available upon reasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan Janota, PhD principal investigator
Motol University Hospital
Thomas E Bachman, MSc principal investigator
Czech Technical University in Prague
Veronika Rafl-Huttova, MSc principal investigator
Czech Technical University in Prague
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fabian ventilator with PRICO system (Acutronic Medical Systems AG, Hirzel, Switzerland); SpO2 averaging time set to 4to6 s, Fabian ventilator with PRICO system (Acutronic Medical Systems AG, Hirzel, Switzerland); SpO2 averaging time set to 10 s and Fabian ventilator with PRICO system (Acutronic Medical Systems AG, Hirzel, Switzerland); SpO2 averaging time set to 16 s in people with Neonatal Respiratory Distress and Very Low Birth Weight Infant, run by Czech Technical University in Prague at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent time in SpO2 target range (time frame: 20 days of intervention on average). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2025.