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

Primary Purpose

Neonatal Respiratory Distress, Very Low Birth Weight Infant

Status
Recruiting
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
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
Sponsored by
Czech Technical University in Prague
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Neonatal Respiratory Distress focused on measuring SpO2 averaging time, pulse oximetry, automatic oxygen control

Eligibility Criteria

2 Weeks - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Motol University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

Averaging time 4to6 s

Averaging time 10 s

Averaging time 16 s

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
February 14, 2022
Last Updated
March 1, 2022
Sponsor
Czech Technical University in Prague
Collaborators
Motol University Hospital, Prague
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1. Study Identification

Unique Protocol Identification Number
NCT05274386
Brief Title
Evaluation of the Impact of SpO2 Averaging Time on Performance of an Automatic FiO2 Control System: a Randomized Study
Official Title
Evaluation of the Impact of SpO2 Averaging Time on Performance of an Automatic FiO2 Control System: a Randomized Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 17, 2022 (Actual)
Primary Completion Date
September 2022 (Anticipated)
Study Completion Date
September 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Czech Technical University in Prague
Collaborators
Motol University Hospital, Prague

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neonatal Respiratory Distress, Very Low Birth Weight Infant
Keywords
SpO2 averaging time, pulse oximetry, automatic oxygen control

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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
Participant
Allocation
Randomized
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Averaging time 4to6 s
Arm Type
Other
Arm Description
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.
Arm Title
Averaging time 10 s
Arm Type
Other
Arm Description
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.
Arm Title
Averaging time 16 s
Arm Type
Other
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Fabian ventilator with PRICO system (Acutronic Medical Systems AG, Hirzel, Switzerland); SpO2 averaging time set to 4to6 s
Intervention Description
The SpO2 averaging time will be set to 4to6 s for the next 12 hours.
Intervention Type
Device
Intervention Name(s)
Fabian ventilator with PRICO system (Acutronic Medical Systems AG, Hirzel, Switzerland); SpO2 averaging time set to 10 s
Intervention Description
The SpO2 averaging time will be set to 10 s for the next 12 hours.
Intervention Type
Device
Intervention Name(s)
Fabian ventilator with PRICO system (Acutronic Medical Systems AG, Hirzel, Switzerland); SpO2 averaging time set to 16 s
Intervention Description
The SpO2 averaging time will be set to 16 s for the next 12 hours.
Primary Outcome Measure Information:
Title
Percent time in SpO2 target range
Description
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.
Time Frame
20 days of intervention on average
Secondary Outcome Measure Information:
Title
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%.
Description
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.
Time Frame
20 days of intervention on average

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All VLBW on respiratory support and oxygen requirements after 2 weeks of age in the NICU are eligible after parental informed consent is obtained. Exclusion Criteria: Parental informed consent is not obtained Recording device for automated control of FiO2 is not available
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jakub Rafl, PhD
Phone
+420728229991
Email
rafl@fbmi.cvut.cz
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan Janota, PhD
Organizational Affiliation
Motol University Hospital, Prague
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Thomas E Bachman, MSc
Organizational Affiliation
Czech Technical University in Prague
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Veronika Rafl-Huttova, MSc
Organizational Affiliation
Czech Technical University in Prague
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jakub Rafl, PhD
Organizational Affiliation
Czech Technical University in Prague
Official's Role
Principal Investigator
Facility Information:
Facility Name
Motol University Hospital
City
Prague
ZIP/Postal Code
15500
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jan Janota, PhD
Email
jan.janota@fnmotol.cz

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
IPD will be available upon reasonable request

Learn more about this trial

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

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