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

Czech Technical University in Prague

Status: Completed

Conditions: Very Low Birth Weight Infant; Neonatal Respiratory Distress

Treatments: Device: Fabian ventilator with PRICO system (Acutronic Medical Systems AG, Hirzel, Switzerland); SpO2 averaging time set to 10 s; Device: Fabian ventilator with PRICO system (Acutronic Medical Systems AG, Hirzel, Switzerland); SpO2 averaging time set to 16 s; Device: Fabian ventilator with PRICO system (Acutronic Medical Systems AG, Hirzel, Switzerland); SpO2 averaging time set to 4to6 s

Study type: Interventional

Funder types: Other

Identifiers

NCT05274386

PricoOptisatAvg

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 2+ weeks old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

---

10 participants in 3 patient groups

Averaging time 4to6 s

Other group

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.

Treatment:

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

Averaging time 10 s

Other group

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.

Treatment:

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

Averaging time 16 s

Other group

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.

Treatment:

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