Closed–loop Oxygen Control Improves Oxygenation in Paediatric Patients Under High–flow Nasal Oxygen––a randomised crossover study

doi:10.21203/rs.3.pex-2032/v1

Method Article

Closed–loop Oxygen Control Improves Oxygenation in Paediatric Patients Under High–flow Nasal Oxygen––a randomised crossover study

https://doi.org/10.21203/rs.3.pex-2032/v1

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Recently, high flow oxygen therapy (HFOT) is becoming more popular in the treatment of any kind of respiratory failure. Pediatric mechanical ventilation consensus conference (PEMVECC) guidelines suggest measuring oxygen saturation by pulse oximetry (SpO2) in all ventilated children and furthermore to measure partial arterial oxygen pressure (PaO2) in moderate‑to‑severe disease in order to prevent excessive use of oxygen while preventing hypoxemia and hyperoxemia. However, from a practical point of view, this may require frequent manual adjustments of the inspired oxygen, which might be unfeasible, especially in high-demand periods, such as the recent COVID19 pandemic. Moreover, the COVID19 pandemic has also highlighted the need for optimizing oxygen usage at the hospital level, since medical oxygen can become a scarce resource in high-demand periods, such as a pandemic. Two proof-of-concept studies showed that automatic oxygen titration (AOT) is feasible in patients receiving high flow nasal oxygen therapy (HFNT) in an exercise-induced desaturation model and in patients with mild acute hypoxemic respiratory failure. This study aims to compare the safety and efficacy of a closed- loop FiO2 controller with conventional manual control of FiO2 during HFOT of pediatric patients in a pediatric intensive care unit (PICU). The hypothesis of this study is: Close-loop FiO2 controller increases the time spent within clinically targeted SpO2 ranges and decreases the time spent outside clinical target SpO2 ranges as compared to manual oxygen control in PICU patients treated with HFOT. This study was registered to clinical trials with the registration number NCT05032365.

Intensive care

paediatric

hypoxaemia

oxygen therapy

high–flow 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.

Patients will be screened daily for inclusion and exclusion criteria. If the subject meets the eligibility criteria, the investigator will discuss the study with the subject or next-of-kin or a legally authorized representative and provide information relating to the potential risks and benefits. Written informed consent will be obtained from each study participant, spouse/next of kin or a legally authorized representative. As the protocol is dealing with PICU patients, it is anticipated that some subjects may not be able to consent because of their medical condition or age. In that case, a legally authorized representative or a subject's family member will be asked to provide consent and that he or she may discontinue the subject's participation at any time without penalty or loss of benefits to which the subject is otherwise entitled. If a legally authorized representative or family member is told about the clinical investigation and the subject's condition improves, the subject is also to be informed as soon as feasible.

The study informed consent form will describe the purpose of the study, randomization, and the importance of participation in both study interventions to the success of the study, the risks, and benefits of participation, the distinction between research and clinical care, and the right to withdraw from the study at any time, in accordance with all applicable regulations.

Each participant only afterwards (or spouse/next of kin or a legally authorized representative) will document his/her provision of informed consent by signing his/her informed consent form. Each signed and dated consent will be maintained by the clinical investigator and a copy of the informed consent will be provided to the subject.

Collection of baseline information will take place only after the subject has given voluntary, documented informed consent.

After obtaining informed consent from the patient or a relative, baseline data will be recorded, and the order of the two modes (closed-loop FiO2 or manual FiO2 controller) will be randomized. After randomization, the physician in charge will decide on the individualized optimal SpO₂ range for each patient, according to the current clinical situation and the medical history.

A total of 5 hours including wash-out

Two hours period where the fraction of inspired oxygen (FiO2) delivered will be automatically titrated based on SpO2 values obtained from the patient during HFOT.

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

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

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2. Mitra S, Singh B, El-Naggar W, McMillan DD. Automated versus manual control of inspired oxygen to target oxygen saturation in preterm infants: a systematic review and meta- analysis. J Perinatol. 2018 Apr;38(4):351-360. doi: 10.1038/s41372-017-0037-z. Epub 2018 Jan 2.

3. Reynolds PR, Miller TL, Volakis LI, Holland N, Dungan GC, Roehr CC, Ives K. Randomised cross-over study of automated oxygen control for preterm infants receiving nasal high flow. Arch Dis Child Fetal Neonatal Ed. 2019 Jul;104(4):F366-F371. doi: 10.1136/archdischild- 2018-315342. Epub 2018 Nov 21.

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5. Lui K, Jones LJ, Foster JP, Davis PG, Ching SK, Oei JL, Osborn DA. Lower versus higher oxygen concentrations titrated to target oxygen saturations during resuscitation of preterm infants at birth. Cochrane Database Syst Rev. 2018 May 4;5:CD010239. doi: 10.1002/14651858.CD010239.pub2. Review.

6. Maiwald CA, Niemarkt HJ, Poets CF, Urschitz MS, König J, Hummler H, Bassler D, Engel C, Franz AR; FiO2-C Study Group. Effects of closed-loop automatic control of the inspiratory fraction of oxygen (FiO(2)-C) on outcome of extremely preterm infants - study protocol of a randomized controlled parallel group multicenter trial for safety and efficacy. BMC Pediatr. 2019 Oct 21;19(1):363. doi: 10.1186/s12887-019-1735-9.

7. Arnal JM, Garnero A, Novotni D, Corno G, Donati SY, Demory D, Quintana G, Ducros L, Laubscher T, Durand-Gasselin J, (2018) Closed loop ventilation mode in Intensive Care Unit: a randomized controlled clinical trial comparing the numbers of manual ventilator setting changes. Minerva Anestesiol 84: 58-67

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9. Harper JC, Kearns NA, Maijers I, Bird GE, Braithwaite I, Shortt NP, Eathorne A, Weatherall M, Beasley R, (2021) Closed-Loop Oxygen Control Using a Novel Nasal High-Flow Device: A Randomized Crossover Trial. Respir Care 66: 416-424

10. Harper J, Kearns N, Bird G, Braithwaite I, Eathorne A, Shortt N, Weatherall M, Beasley R, (2021) Automatic versus manual oxygen titration using a novel nasal high-flow device in medical inpatients with an acute illness: a randomised controlled trial. BMJ Open Respir Res 8

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