Protocol for Closed-Loop O2 Use During Invasive Mechanical Ventilation Of Pediatric Patients (CLOUDIMPP): A Randomized Cross-Over Study

doi:10.21203/rs.3.pex-2245/v1

Method Article

Protocol for Closed-Loop O2 Use During Invasive Mechanical Ventilation Of Pediatric Patients (CLOUDIMPP): A Randomized Cross-Over Study

https://doi.org/10.21203/rs.3.pex-2245/v1

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Oxygen is an effective treatment for any type of respiratory failure. To prevent hypoxemia and hyperoxemia, the Pediatric mechanical ventilation consensus conference (PEMVECC) recommends monitoring oxygen saturation with pulse oximetry (SpO2) in all ventilated children and measuring partial arterial oxygen pressure (PaO2) in moderate to severe cases. However, this may require manual adjustments of inspired oxygen, which can be burdensome during high-demand periods such as the current COVID-19 epidemic. Additionally, the pandemic has highlighted the importance of optimizing oxygen use in hospitals as it may become a scarce resource during such high-demand periods. Previous studies have shown that automatic oxygen titration (AOT) is feasible in patients receiving respiratory support therapy, including those with mild acute hypoxemic respiratory failure and exercise-induced desaturation. This study aims to assess the safety and efficacy of a closed-loop FiO2 controller in comparison to traditional manual FiO2 regulation during invasive mechanical ventilation (IMV) in pediatric patients within a pediatric critical care unit (PICU). The hypothesis is that the closed-loop FiO2 controller will increase the time spent within clinically intended SpO2 ranges and decrease the time spent outside these ranges. The research is registered under NCT05714527

Intensive care

paediatric

hypoxaemia

oxygen therapy

automation

closed–loop

oxygen controller

Device: The algorithm is a closed loop algorithm that adjust the fraction of inspired oxygen (FiO2) based on the oxygen saturation measured by pulse oximetry (SpO2). This algorithm is integrated into the Hamilton Medical C1 (Hamilton Medical AG, Bonaduz, Switzerland) ventilator. This ventilator is equipped with its own Masimo Setline (Masimo Corporation, Irvine, USA) pulse oximeter. Both these devices are CE certified. Saturation data is fed into the system through an integrated Masimo (Irvine, USA) pulse oximeter. For this purpose, an additional pulse oximeter sensor is placed on of the infants extremities during the duration of the study.

Active Comparator: Conventional FiO2 controller

Two hours period where the FiO2 delivered will be conventionally adjusted by the healthcare personnel based on visual analysis of SpO2 values through clinical guidelines

1.1 Description of the intervention software

The Automatic FiO2 option provides automated adjustment of the ventilator Oxygen setting to help maintain the patient's SpO2 in a defined target range.

The option is available in all invasive and non-invasive ventilation modes except INTELLiVENT-ASV.

During use, you define the SpO2 target range, as well as the two SpO2 emergency limits. The ventilator adjusts the Oxygen setting to keep the patient's SpO2 within these specified values.

Indications for use

Use of the Automatic FiO2 option is indicated for patients needing oxygen therapy, who are:

· Mechanically ventilated (invasive or noninvasive) and/or using high flow oxygen therapy

· Adult, pediatric, and neonatal (gestational age greater than 36 weeks) patients

Contraindications

Use of the Automatic FiO2 option is contraindicated for any of the following patient groups and conditions:

· Pre-term infants

· Dyshemoglobin is expected or observed

· The difference between SpO2 and SaO2 is greater than 5%

Accessing the Automatic FiO2 window

Once the option is enabled, the Automatic FiO2 window provides access to the SpO2 target range high and low controls, the emergency SpO2 range high and low controls, and the Oxygen msg control, as well as the option On and Off buttons.

To access the Automatic FiO2 window

If not already enabled, enable the Automatic FiO2 option in Configuration.

For details about adding software options, see your ventilator Operator's Manual.

Do either of the following:

– If Automatic FiO2 is already set to On, touch the Oxygen control with blue rotating comets to directly open the window.

– Touch System > Info > Automatic FiO2.

Daily screening of patients will be conducted to assess their eligibility for the study based on inclusion and exclusion criteria. Those who meet the criteria will be approached by the investigator or a legally authorized representative to discuss the study's potential risks and benefits. Written informed consent will be obtained from each participant or their legally authorized representative, with the understanding that some subjects may be unable to provide consent due to their medical condition or age.

If a legally authorized representative or family member is asked to provide consent, they have the right to discontinue the subject's participation at any time without penalty or loss of benefits. If a legally authorized representative or family member is informed about the clinical investigation and the subject's condition improves, the subject should also be informed as soon as possible.

The informed consent form for the study will explain its purpose, randomization, the importance of participating in both study interventions, the risks and benefits of participation, the distinction between research and clinical care, and the right to withdraw from the study at any time. Each participant or their legally authorized representative will document their consent by signing the informed consent form, which will be maintained by the clinical investigator, and a copy will be given to the subject.

Baseline information will only be collected after obtaining voluntary, documented informed consent. After consent is obtained, baseline data will be recorded, and the order of the two modes (closed-loop FiO2 or manual FiO2 controller) will be randomized. The physician in charge will then determine the individualized optimal SpO2 range for each patient based on the current clinical situation and medical history.

The study will consist of a 5-hour duration, which includes a wash-out period. During the first two hours of the study, the fraction of inspired oxygen (FiO2) delivered to the patient during invasive mechanical ventilation (IMV) will be automatically adjusted based on the patient's SpO2 values. During the next two hours, healthcare personnel will conventionally adjust the FiO2 delivered to the patient based on visual analysis of SpO2 values, following clinical guidelines.

Primary endpoint:

Percentage of time spent in optimal SpO2 range

Secondary endpoints:

1. Percentage of time spent in sub-optimal SpO2 range

2. Mean FiO2

3. Mean SpO2/FiO2

4. Number of manual adjustments

5. Number of alarms

6. Percentage of time with SpO2 signal available

7. Percentage of time with SpO2 below 88 and 85 percent

8. Number of events with SpO2 below 88 and 85 percent

9. Percentage of time with FiO2 below 40 percent, 60 percent and 100 percent

10. Total oxygen use

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13. Sandal O, Ceylan G, Topal S, et al. Closed–loop oxygen control improves oxygenation in pediatric patients under high–flow nasal oxygen—A randomized crossover study. Frontiers in medicine 2022; 9.

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