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Automated oxygen control in preterm babies on respiratory support: protocol for a randomised crossover trial
Hafiz Muhammad Aamir Yousuf1, Ali Shabbir Hussain2, Georg M Schmolzer3,4
1Department of Pediatrics and Child Health, Section Neonatology, The Aga Khan University Hospital Main Campus Karachi, Karachi, Pakistan.
Insights
Automated oxygen control in ventilators effectively maintains target oxygen saturation (SpO2) in preterm infants, reducing abnormal oxygen levels compared to manual adjustments. This study compares automated versus manual oxygen control for neonatal respiratory support.
Area of Science:
- Neonatal intensive care
- Respiratory medicine
- Clinical trial methodology
Background:
- Preterm infants in NICU often require respiratory support.
- Maintaining target oxygen saturation (SpO2) is crucial.
- Manual FiO2 adjustment by nurses is standard, but automated systems exist.
Purpose of the Study:
- To assess the effectiveness of automated oxygen control versus manual control in maintaining SpO2 within the target range in preterm infants.
- To compare the incidence of abnormal high and low SpO2 levels between automated and manual oxygen control.
- To evaluate the impact of automated systems on oxygenation stability and nurse workload.
Main Methods:
- Single-centre, non-blinded, randomised crossover trial.
- Recruitment of 26 preterm infants requiring respiratory support.
- Comparison of 12-hour periods of automated versus manual oxygen control.
- Primary outcome: efficacy in maintaining SpO2 within the target range.
- Secondary outcomes: abnormal SpO2 levels, fluctuations, FiO2 usage, and medication impact.
Main Results:
- The study protocol is designed to compare automated and manual oxygen control systems.
- Key metrics include maintaining SpO2 within the target range and minimizing oxygen fluctuations.
- Analysis will also consider FiO2 requirements and the influence of other medications.
Conclusions:
- Automated oxygen control may offer improved stability in maintaining target SpO2 for preterm infants.
- This technology has the potential to reduce clinical workload and improve patient outcomes.
- Further research will confirm the clinical benefits and optimal implementation of automated systems.
Introduction:
Respiratory support is frequently needed for babies admitted to the neonatal intensive care unit. Among them, preterm babies are most likely to have issues of respiratory distress, and they may need invasive or non-invasive breathing support. Providing respiratory support, keeping the oxygen saturation (SpO2) in the target range (TR) and preventing abnormal high and low oxygen levels should be the aim of providing respiratory therapy. Usually, this control is achieved by manual adjustment of FiO2 (fraction of inspired oxygen) by bedside staff nurses to keep SpO2 in TR. However, the latest ventilators have automated oxygen control devices that adjust the FiO2 to keep SpO2 in TR. This study protocol is prepared to assess the effectiveness of automated versus manual oxygen control in keeping SpO2 in TR.
Methods And Analysis:
This is a single-centre, non-blinded, randomised crossover trial that aims to recruit 26 preterm babies who may need invasive or non-invasive respiratory support. The 12-hour periods of automated oxygen control by ventilator will be compared with 12 hours of manual oxygen control by bedside staff nurse. The primary outcome will compare both interventions and will assess their efficacy to keep SpO2 in TR. Secondary outcomes will compare abnormal high and low SpO2 levels, and number and duration of fluctuations in both interventions. Median FiO2 values and median number of manual adjustments of FiO2 will also be compared. Secondary outcomes will also look for the impact of sedative and respiratory stimulant medications on target oxygen saturation.
Ethics And Dissemination:
The ethics review committee at Aga Khan University Hospital Karachi has given ethical approval for this trial (approval number: 2024-10189-30775). Results from this trial will be published in journals.
Trial Registration Number:
NCT06622161.
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