Comparison of two devices for automated oxygen control in preterm infants: a randomised crossover trial

Hylke H Salverda; Sophie J E Cramer; Ruben S G M Witlox; Timothy J Gale; Peter A Dargaville; Steffen C Pauws; Arjan B Te Pas

doi:10.1136/archdischild-2020-321387

Comparison of two devices for automated oxygen control in preterm infants: a randomised crossover trial

Hylke H Salverda, Sophie J E Cramer, Ruben S G M Witlox, Timothy J Gale, Peter A Dargaville, Steffen C Pauws, Arjan B Te Pas

Research output: Contribution to journal › Article › Scientific › peer-review

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Abstract

OBJECTIVE: To compare the effect of two different automated oxygen control devices on target range (TR) time and occurrence of hypoxaemic and hyperoxaemic episodes.

DESIGN: Randomised cross-over study.

SETTING: Tertiary level neonatal unit in the Netherlands.

PATIENTS: Preterm infants (n=15) born between 24+0 and 29+6 days of gestation, receiving invasive or non-invasive respiratory support with oxygen saturation (SpO2) TR of 91%-95%. Median gestational age 26 weeks and 4 days (IQR 25 weeks 3 days-27 weeks 6 days) and postnatal age 19 (IQR 17-24) days.

INTERVENTIONS: Inspired oxygen concentration was titrated by the OxyGenie controller (SLE6000 ventilator) and the CLiO2 controller (AVEA ventilator) for 24 hours each, in a random sequence, with the respiratory support mode kept constant.

MAIN OUTCOME MEASURES: Time spent within set SpO2 TR (91%-95% with supplemental oxygen and 91%-100% without supplemental oxygen).

RESULTS: Time spent within the SpO2 TR was higher during OxyGenie control (80.2 (72.6-82.4)% vs 68.5 (56.7-79.3)%, p<0.005). Less time was spent above TR while in supplemental oxygen (6.3 (5.1-9.9)% vs 15.9 (11.5-30.7)%, p<0.005) but more time spent below TR during OxyGenie control (14.7 (11.8%-17.2%) vs 9.3 (8.2-12.6)%, p<0.05). There was no significant difference in time with SpO2 <80% (0.5 (0.1-1.0)% vs 0.2 (0.1-0.4)%, p=0.061). Long-lasting SpO2 deviations occurred less frequently during OxyGenie control.

CONCLUSIONS: The OxyGenie control algorithm was more effective in keeping the oxygen saturation within TR and preventing hyperoxaemia and equally effective in preventing hypoxaemia (SpO2 <80%), although at the cost of a small increase in mild hypoxaemia.

TRIAL REGISTRY NUMBER: NCT03877198.

Original language	English
Pages (from-to)	F20-F25
Number of pages	6
Journal	Archives of Disease in Childhood. Fetal and Neonatal Edition
Volume	107
Issue number	1
DOIs	https://doi.org/10.1136/archdischild-2020-321387
Publication status	Published - 1 Jan 2022

Keywords

Algorithms
Cross-Over Studies
Humans
Hypoxia/etiology
Infant, Newborn
Infant, Premature
Oxygen Saturation
Respiration, Artificial/adverse effects
Respiratory Distress Syndrome, Newborn/blood
Ventilators, Mechanical

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10.1136/archdischild-2020-321387

Cite this

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title = "Comparison of two devices for automated oxygen control in preterm infants: a randomised crossover trial",

abstract = "OBJECTIVE: To compare the effect of two different automated oxygen control devices on target range (TR) time and occurrence of hypoxaemic and hyperoxaemic episodes.DESIGN: Randomised cross-over study.SETTING: Tertiary level neonatal unit in the Netherlands.PATIENTS: Preterm infants (n=15) born between 24+0 and 29+6 days of gestation, receiving invasive or non-invasive respiratory support with oxygen saturation (SpO2) TR of 91%-95%. Median gestational age 26 weeks and 4 days (IQR 25 weeks 3 days-27 weeks 6 days) and postnatal age 19 (IQR 17-24) days.INTERVENTIONS: Inspired oxygen concentration was titrated by the OxyGenie controller (SLE6000 ventilator) and the CLiO2 controller (AVEA ventilator) for 24 hours each, in a random sequence, with the respiratory support mode kept constant.MAIN OUTCOME MEASURES: Time spent within set SpO2 TR (91%-95% with supplemental oxygen and 91%-100% without supplemental oxygen).RESULTS: Time spent within the SpO2 TR was higher during OxyGenie control (80.2 (72.6-82.4)% vs 68.5 (56.7-79.3)%, p<0.005). Less time was spent above TR while in supplemental oxygen (6.3 (5.1-9.9)% vs 15.9 (11.5-30.7)%, p<0.005) but more time spent below TR during OxyGenie control (14.7 (11.8%-17.2%) vs 9.3 (8.2-12.6)%, p<0.05). There was no significant difference in time with SpO2 <80% (0.5 (0.1-1.0)% vs 0.2 (0.1-0.4)%, p=0.061). Long-lasting SpO2 deviations occurred less frequently during OxyGenie control.CONCLUSIONS: The OxyGenie control algorithm was more effective in keeping the oxygen saturation within TR and preventing hyperoxaemia and equally effective in preventing hypoxaemia (SpO2 <80%), although at the cost of a small increase in mild hypoxaemia.TRIAL REGISTRY NUMBER: NCT03877198.",

keywords = "Algorithms, Cross-Over Studies, Humans, Hypoxia/etiology, Infant, Newborn, Infant, Premature, Oxygen Saturation, Respiration, Artificial/adverse effects, Respiratory Distress Syndrome, Newborn/blood, Ventilators, Mechanical",

author = "Salverda, {Hylke H} and Cramer, {Sophie J E} and Witlox, {Ruben S G M} and Gale, {Timothy J} and Dargaville, {Peter A} and Pauws, {Steffen C} and {Te Pas}, {Arjan B}",

note = "Funding Information: This work was supported by SLE Limited by an unrestricted research grant. Publisher Copyright: {\textcopyright} Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.",

year = "2022",

month = jan,

day = "1",

doi = "10.1136/archdischild-2020-321387",

language = "English",

volume = "107",

pages = "F20--F25",

journal = "Archives of Disease in Childhood. Fetal and Neonatal Edition",

issn = "1359-2998",

publisher = "BMJ Publishing Group",

number = "1",

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TY - JOUR

T1 - Comparison of two devices for automated oxygen control in preterm infants

T2 - a randomised crossover trial

AU - Salverda, Hylke H

AU - Cramer, Sophie J E

AU - Witlox, Ruben S G M

AU - Gale, Timothy J

AU - Dargaville, Peter A

AU - Pauws, Steffen C

AU - Te Pas, Arjan B

N1 - Funding Information: This work was supported by SLE Limited by an unrestricted research grant. Publisher Copyright: © Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

PY - 2022/1/1

Y1 - 2022/1/1

N2 - OBJECTIVE: To compare the effect of two different automated oxygen control devices on target range (TR) time and occurrence of hypoxaemic and hyperoxaemic episodes.DESIGN: Randomised cross-over study.SETTING: Tertiary level neonatal unit in the Netherlands.PATIENTS: Preterm infants (n=15) born between 24+0 and 29+6 days of gestation, receiving invasive or non-invasive respiratory support with oxygen saturation (SpO2) TR of 91%-95%. Median gestational age 26 weeks and 4 days (IQR 25 weeks 3 days-27 weeks 6 days) and postnatal age 19 (IQR 17-24) days.INTERVENTIONS: Inspired oxygen concentration was titrated by the OxyGenie controller (SLE6000 ventilator) and the CLiO2 controller (AVEA ventilator) for 24 hours each, in a random sequence, with the respiratory support mode kept constant.MAIN OUTCOME MEASURES: Time spent within set SpO2 TR (91%-95% with supplemental oxygen and 91%-100% without supplemental oxygen).RESULTS: Time spent within the SpO2 TR was higher during OxyGenie control (80.2 (72.6-82.4)% vs 68.5 (56.7-79.3)%, p<0.005). Less time was spent above TR while in supplemental oxygen (6.3 (5.1-9.9)% vs 15.9 (11.5-30.7)%, p<0.005) but more time spent below TR during OxyGenie control (14.7 (11.8%-17.2%) vs 9.3 (8.2-12.6)%, p<0.05). There was no significant difference in time with SpO2 <80% (0.5 (0.1-1.0)% vs 0.2 (0.1-0.4)%, p=0.061). Long-lasting SpO2 deviations occurred less frequently during OxyGenie control.CONCLUSIONS: The OxyGenie control algorithm was more effective in keeping the oxygen saturation within TR and preventing hyperoxaemia and equally effective in preventing hypoxaemia (SpO2 <80%), although at the cost of a small increase in mild hypoxaemia.TRIAL REGISTRY NUMBER: NCT03877198.

AB - OBJECTIVE: To compare the effect of two different automated oxygen control devices on target range (TR) time and occurrence of hypoxaemic and hyperoxaemic episodes.DESIGN: Randomised cross-over study.SETTING: Tertiary level neonatal unit in the Netherlands.PATIENTS: Preterm infants (n=15) born between 24+0 and 29+6 days of gestation, receiving invasive or non-invasive respiratory support with oxygen saturation (SpO2) TR of 91%-95%. Median gestational age 26 weeks and 4 days (IQR 25 weeks 3 days-27 weeks 6 days) and postnatal age 19 (IQR 17-24) days.INTERVENTIONS: Inspired oxygen concentration was titrated by the OxyGenie controller (SLE6000 ventilator) and the CLiO2 controller (AVEA ventilator) for 24 hours each, in a random sequence, with the respiratory support mode kept constant.MAIN OUTCOME MEASURES: Time spent within set SpO2 TR (91%-95% with supplemental oxygen and 91%-100% without supplemental oxygen).RESULTS: Time spent within the SpO2 TR was higher during OxyGenie control (80.2 (72.6-82.4)% vs 68.5 (56.7-79.3)%, p<0.005). Less time was spent above TR while in supplemental oxygen (6.3 (5.1-9.9)% vs 15.9 (11.5-30.7)%, p<0.005) but more time spent below TR during OxyGenie control (14.7 (11.8%-17.2%) vs 9.3 (8.2-12.6)%, p<0.05). There was no significant difference in time with SpO2 <80% (0.5 (0.1-1.0)% vs 0.2 (0.1-0.4)%, p=0.061). Long-lasting SpO2 deviations occurred less frequently during OxyGenie control.CONCLUSIONS: The OxyGenie control algorithm was more effective in keeping the oxygen saturation within TR and preventing hyperoxaemia and equally effective in preventing hypoxaemia (SpO2 <80%), although at the cost of a small increase in mild hypoxaemia.TRIAL REGISTRY NUMBER: NCT03877198.

KW - Algorithms

KW - Cross-Over Studies

KW - Humans

KW - Hypoxia/etiology

KW - Infant, Newborn

KW - Infant, Premature

KW - Oxygen Saturation

KW - Respiration, Artificial/adverse effects

KW - Respiratory Distress Syndrome, Newborn/blood

KW - Ventilators, Mechanical

UR - http://www.scopus.com/inward/record.url?scp=85107743246&partnerID=8YFLogxK

U2 - 10.1136/archdischild-2020-321387

DO - 10.1136/archdischild-2020-321387

M3 - Article

C2 - 34112721

SN - 1359-2998

VL - 107

SP - F20-F25

JO - Archives of Disease in Childhood. Fetal and Neonatal Edition

JF - Archives of Disease in Childhood. Fetal and Neonatal Edition

IS - 1

ER -

Comparison of two devices for automated oxygen control in preterm infants: a randomised crossover trial

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