Clinical use of cerebral oximetry in extremely preterm infants is feasible

Simon Hyttel-Sørensen; Topun Austin; Frank van Bel; Manon Benders; Olivier Claris; Eugene M Dempsey; Monica Fumagalli; Christian Gluud; Cornelia Hagmann; Lena Hellström-Westas; Petra Lemmers; Gunnar Naulaers; Wim van Oeveren; Adelina Pellicer; Gerhard Pichler; Claudia Roll; Lina Saem Støy; Martin Wolf; Gorm Greisen

Clinical use of cerebral oximetry in extremely preterm infants is feasible

Simon Hyttel-Sørensen, Topun Austin, Frank van Bel, Manon Benders, Olivier Claris, Eugene M Dempsey, Monica Fumagalli, Christian Gluud, Cornelia Hagmann, Lena Hellström-Westas, Petra Lemmers, Gunnar Naulaers, Wim van Oeveren, Adelina Pellicer, Gerhard Pichler, Claudia Roll, Lina Saem Støy, Martin Wolf, Gorm Greisen

28 Citations (Scopus)

Abstract

INTRODUCTION: The research programme Safeguarding the Brains of our smallest Children (SafeBoosC) aims to test the benefits and harms of cerebral near-infrared spectroscopy (NIRS) oximetry in infants born before 28 weeks of gestation. In a phase II trial, infants will be randomised to visible cerebral NIRS oximetry with pre-specified treatment guidelines compared to standard care with blinded NIRS-monitoring. The primary outcome is duration multiplied with the extent outside the normal range of regional tissue oxygen saturation of haemoglobin (rStO₂) of 55 to 85% in percentage hours (burden). This study was a pilot of the Visible Oximetry Group. MATERIAL AND METHODS: This was an observational study including ten infants. RESULTS: The median gestational age was 26 weeks + three days, and the median start-up time was 133 minutes after delivery. The median recording time was 69.7 hours, mean rStO₂ was 64.2 ± 4.5%, median burden of hyper- and hypoxia was 30.3% hours (range 2.8-112.3). Clinical staff responded to an out of range value 29 times - only once to values above 85%. In comparison, there were 83 periods of more than ten minutes with an rStO₂ below 55% and four episodes with an rStO₂ above 85%. These periods accounted for 72% of the total hypoxia burden. A total of 18 of the 29 interventions were adjustments of FiO₂ which in 13 of the 18 times resulted in an out-of-range SpO₂. Two infants suffered second-degree burns from the sensor. Five infants died. In all cases, this was unrelated to NIRS monitoring and treatment. CONCLUSION: The intervention of early cerebral NIRS monitoring proved feasible, but prolonged periods of hypoxia went untreated. Thus, a revision of the treatment guideline and an alarm system is required. FUNDING: The Elsass Foundation funded the present study. TRIAL REGISTRATION: Clinicaltrials.gov: NCT01530360.

Original language	English
Journal	Danish Medical Bulletin (Online)
Volume	60
Issue number	1
Pages (from-to)	A4533
ISSN	1603-9629
Publication status	Published - 2013

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Hyttel-Sørensen, S., Austin, T., van Bel, F., Benders, M., Claris, O., Dempsey, E. M., Fumagalli, M., Gluud, C., Hagmann, C., Hellström-Westas, L., Lemmers, P., Naulaers, G., Oeveren, W. V., Pellicer, A., Pichler, G., Roll, C., Støy, L. S., Wolf, M., & Greisen, G. (2013). Clinical use of cerebral oximetry in extremely preterm infants is feasible. Danish Medical Bulletin (Online), 60(1), A4533. http://www.ncbi.nlm.nih.gov/pubmed/23340184

Hyttel-Sørensen, S, Austin, T, van Bel, F, Benders, M, Claris, O, Dempsey, EM, Fumagalli, M, Gluud, C, Hagmann, C, Hellström-Westas, L, Lemmers, P, Naulaers, G, Oeveren, WV, Pellicer, A, Pichler, G, Roll, C, Støy, LS, Wolf, M & Greisen, G 2013, 'Clinical use of cerebral oximetry in extremely preterm infants is feasible', Danish Medical Bulletin (Online), vol. 60, no. 1, pp. A4533. <http://www.ncbi.nlm.nih.gov/pubmed/23340184>

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title = "Clinical use of cerebral oximetry in extremely preterm infants is feasible",

abstract = "INTRODUCTION: The research programme Safeguarding the Brains of our smallest Children (SafeBoosC) aims to test the benefits and harms of cerebral near-infrared spectroscopy (NIRS) oximetry in infants born before 28 weeks of gestation. In a phase II trial, infants will be randomised to visible cerebral NIRS oximetry with pre-specified treatment guidelines compared to standard care with blinded NIRS-monitoring. The primary outcome is duration multiplied with the extent outside the normal range of regional tissue oxygen saturation of haemoglobin (rStO2) of 55 to 85% in percentage hours (burden). This study was a pilot of the Visible Oximetry Group. MATERIAL AND METHODS: This was an observational study including ten infants. RESULTS: The median gestational age was 26 weeks + three days, and the median start-up time was 133 minutes after delivery. The median recording time was 69.7 hours, mean rStO2 was 64.2 ± 4.5%, median burden of hyper- and hypoxia was 30.3% hours (range 2.8-112.3). Clinical staff responded to an out of range value 29 times - only once to values above 85%. In comparison, there were 83 periods of more than ten minutes with an rStO2 below 55% and four episodes with an rStO2 above 85%. These periods accounted for 72% of the total hypoxia burden. A total of 18 of the 29 interventions were adjustments of FiO2 which in 13 of the 18 times resulted in an out-of-range SpO2. Two infants suffered second-degree burns from the sensor. Five infants died. In all cases, this was unrelated to NIRS monitoring and treatment. CONCLUSION: The intervention of early cerebral NIRS monitoring proved feasible, but prolonged periods of hypoxia went untreated. Thus, a revision of the treatment guideline and an alarm system is required. FUNDING: The Elsass Foundation funded the present study. TRIAL REGISTRATION: Clinicaltrials.gov: NCT01530360.",

author = "Simon Hyttel-S{\o}rensen and Topun Austin and {van Bel}, Frank and Manon Benders and Olivier Claris and Dempsey, {Eugene M} and Monica Fumagalli and Christian Gluud and Cornelia Hagmann and Lena Hellstr{\"o}m-Westas and Petra Lemmers and Gunnar Naulaers and Oeveren, {Wim van} and Adelina Pellicer and Gerhard Pichler and Claudia Roll and St{\o}y, {Lina Saem} and Martin Wolf and Gorm Greisen",

year = "2013",

language = "English",

volume = "60",

pages = "A4533",

journal = "Danish Medical Journal",

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T1 - Clinical use of cerebral oximetry in extremely preterm infants is feasible

AU - Hyttel-Sørensen, Simon

AU - Austin, Topun

AU - van Bel, Frank

AU - Benders, Manon

AU - Claris, Olivier

AU - Dempsey, Eugene M

AU - Fumagalli, Monica

AU - Gluud, Christian

AU - Hagmann, Cornelia

AU - Hellström-Westas, Lena

AU - Lemmers, Petra

AU - Naulaers, Gunnar

AU - Oeveren, Wim van

AU - Pellicer, Adelina

AU - Pichler, Gerhard

AU - Roll, Claudia

AU - Støy, Lina Saem

AU - Wolf, Martin

AU - Greisen, Gorm

PY - 2013

Y1 - 2013

N2 - INTRODUCTION: The research programme Safeguarding the Brains of our smallest Children (SafeBoosC) aims to test the benefits and harms of cerebral near-infrared spectroscopy (NIRS) oximetry in infants born before 28 weeks of gestation. In a phase II trial, infants will be randomised to visible cerebral NIRS oximetry with pre-specified treatment guidelines compared to standard care with blinded NIRS-monitoring. The primary outcome is duration multiplied with the extent outside the normal range of regional tissue oxygen saturation of haemoglobin (rStO2) of 55 to 85% in percentage hours (burden). This study was a pilot of the Visible Oximetry Group. MATERIAL AND METHODS: This was an observational study including ten infants. RESULTS: The median gestational age was 26 weeks + three days, and the median start-up time was 133 minutes after delivery. The median recording time was 69.7 hours, mean rStO2 was 64.2 ± 4.5%, median burden of hyper- and hypoxia was 30.3% hours (range 2.8-112.3). Clinical staff responded to an out of range value 29 times - only once to values above 85%. In comparison, there were 83 periods of more than ten minutes with an rStO2 below 55% and four episodes with an rStO2 above 85%. These periods accounted for 72% of the total hypoxia burden. A total of 18 of the 29 interventions were adjustments of FiO2 which in 13 of the 18 times resulted in an out-of-range SpO2. Two infants suffered second-degree burns from the sensor. Five infants died. In all cases, this was unrelated to NIRS monitoring and treatment. CONCLUSION: The intervention of early cerebral NIRS monitoring proved feasible, but prolonged periods of hypoxia went untreated. Thus, a revision of the treatment guideline and an alarm system is required. FUNDING: The Elsass Foundation funded the present study. TRIAL REGISTRATION: Clinicaltrials.gov: NCT01530360.

AB - INTRODUCTION: The research programme Safeguarding the Brains of our smallest Children (SafeBoosC) aims to test the benefits and harms of cerebral near-infrared spectroscopy (NIRS) oximetry in infants born before 28 weeks of gestation. In a phase II trial, infants will be randomised to visible cerebral NIRS oximetry with pre-specified treatment guidelines compared to standard care with blinded NIRS-monitoring. The primary outcome is duration multiplied with the extent outside the normal range of regional tissue oxygen saturation of haemoglobin (rStO2) of 55 to 85% in percentage hours (burden). This study was a pilot of the Visible Oximetry Group. MATERIAL AND METHODS: This was an observational study including ten infants. RESULTS: The median gestational age was 26 weeks + three days, and the median start-up time was 133 minutes after delivery. The median recording time was 69.7 hours, mean rStO2 was 64.2 ± 4.5%, median burden of hyper- and hypoxia was 30.3% hours (range 2.8-112.3). Clinical staff responded to an out of range value 29 times - only once to values above 85%. In comparison, there were 83 periods of more than ten minutes with an rStO2 below 55% and four episodes with an rStO2 above 85%. These periods accounted for 72% of the total hypoxia burden. A total of 18 of the 29 interventions were adjustments of FiO2 which in 13 of the 18 times resulted in an out-of-range SpO2. Two infants suffered second-degree burns from the sensor. Five infants died. In all cases, this was unrelated to NIRS monitoring and treatment. CONCLUSION: The intervention of early cerebral NIRS monitoring proved feasible, but prolonged periods of hypoxia went untreated. Thus, a revision of the treatment guideline and an alarm system is required. FUNDING: The Elsass Foundation funded the present study. TRIAL REGISTRATION: Clinicaltrials.gov: NCT01530360.

M3 - Journal article

SN - 2245-1919

VL - 60

SP - A4533

JO - Danish Medical Journal

JF - Danish Medical Journal

IS - 1

ER -

Clinical use of cerebral oximetry in extremely preterm infants is feasible

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