Reliability and performance of the IRRAflow® system for intracranial lavage and evacuation of hematomas-A technical note

Mette Haldrup; Mojtaba Nazari; Chenghao Gu; Mads Rasmussen; Stig Dyrskog; Claus Ziegler Simonsen; Mads Grønhøj; Frantz Rom Poulsen; Naveed Ur Rehman; Anders Rosendal Korshoej

doi:10.1371/journal.pone.0297131

Reliability and performance of the IRRAflow® system for intracranial lavage and evacuation of hematomas-A technical note

Mette Haldrup, Mojtaba Nazari, Chenghao Gu, Mads Rasmussen, Stig Dyrskog, Claus Ziegler Simonsen, Mads Grønhøj, Frantz Rom Poulsen, Naveed Ur Rehman, Anders Rosendal Korshoej

Research output: Contribution to journal/Conference contribution in journal/Contribution to newspaper › Journal article › Research › peer-review

Abstract

Background Intraventricular hemorrhage (IVH) is a severe condition with poor outcomes and high mortality. IRRAflow® (IRRAS AB) is a new technology introduced to accelerate IVH clearance by minimally invasive wash-out. The IRRAflow® system performs active and controlled intracranial irrigation and aspiration with physiological saline, while simultaneously monitoring and maintaining a stable intracranial pressure (ICP). We addressed important aspects of the device implementation and intracranial lavage. Method To allow versatile investigation of multiple device parameters, we designed an ex vivo lab setup. We evaluated 1) compatibility between the IRRAflow® catheter and the Silverline f10 bolt (Spiegelberg), 2) the physiological and hydrodynamic effects of varying the IRRAflow® settings, 3) the accuracy of the IRRAflow® injection volumes, and 4) the reliability of the internal ICP monitor of the IRRAflow®. Results The IRRAflow® catheter was not compatible with Silverline bolt fixation, which was associated with leakage and obstruction. Design space exploration of IRRAflow® settings revealed that appropriate settings included irrigation rate 20 ml/h with a drainage bag height at 0 cm, irrigation rate 90 ml/h with a drainage bag height at 19 cm and irrigation rate 180 ml/h with a drainage bag height at 29 cm. We found the injection volume performed by the IRRAflow® to be stable and reliable, while the internal ICP monitor was compromised in several ways. We observed a significant mean drift difference of 3.16 mmHg (variance 0.4, p = 0.05) over a 24-hour test period with a mean 24-hour drift of 3.66 mmHg (variance 0.28) in the pressures measured by the IRRAflow® compared to 0.5 mmHg (variance 1.12) in the Raumedic measured pressures. Conclusion Bolting of the IRRAflow® catheter using the Medtronic Silverline® bolt is not recommendable. Increased irrigation rates are recommendable followed by a decrease in drainage bag level. ICP measurement using the IRRAflow® device was unreliable and should be accompanied by a control ICP monitor device in clinical settings.

Original language	English
Article number	e0297131
Journal	PLOS ONE
Volume	19
Issue	4 April
Number of pages	15
ISSN	1932-6203
DOIs	https://doi.org/10.1371/journal.pone.0297131
Publication status	Published - Apr 2024

Keywords

Humans
Reproducibility of Results
Therapeutic Irrigation
Intracranial Pressure/physiology
Monitoring, Physiologic
Cerebral Hemorrhage/therapy
Hematoma

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Haldrup, M., Nazari, M., Gu, C., Rasmussen, M., Dyrskog, S., Ziegler Simonsen, C., Grønhøj, M., Poulsen, F. R., Ur Rehman, N., & Rosendal Korshoej, A. (2024). Reliability and performance of the IRRAflow® system for intracranial lavage and evacuation of hematomas-A technical note. PLOS ONE, 19(4 April), Article e0297131. https://doi.org/10.1371/journal.pone.0297131

@article{dced008e842941389cd16e2003c59f17,

title = "Reliability and performance of the IRRAflow{\textregistered} system for intracranial lavage and evacuation of hematomas-A technical note",

abstract = "Background Intraventricular hemorrhage (IVH) is a severe condition with poor outcomes and high mortality. IRRAflow{\textregistered} (IRRAS AB) is a new technology introduced to accelerate IVH clearance by minimally invasive wash-out. The IRRAflow{\textregistered} system performs active and controlled intracranial irrigation and aspiration with physiological saline, while simultaneously monitoring and maintaining a stable intracranial pressure (ICP). We addressed important aspects of the device implementation and intracranial lavage. Method To allow versatile investigation of multiple device parameters, we designed an ex vivo lab setup. We evaluated 1) compatibility between the IRRAflow{\textregistered} catheter and the Silverline f10 bolt (Spiegelberg), 2) the physiological and hydrodynamic effects of varying the IRRAflow{\textregistered} settings, 3) the accuracy of the IRRAflow{\textregistered} injection volumes, and 4) the reliability of the internal ICP monitor of the IRRAflow{\textregistered}. Results The IRRAflow{\textregistered} catheter was not compatible with Silverline bolt fixation, which was associated with leakage and obstruction. Design space exploration of IRRAflow{\textregistered} settings revealed that appropriate settings included irrigation rate 20 ml/h with a drainage bag height at 0 cm, irrigation rate 90 ml/h with a drainage bag height at 19 cm and irrigation rate 180 ml/h with a drainage bag height at 29 cm. We found the injection volume performed by the IRRAflow{\textregistered} to be stable and reliable, while the internal ICP monitor was compromised in several ways. We observed a significant mean drift difference of 3.16 mmHg (variance 0.4, p = 0.05) over a 24-hour test period with a mean 24-hour drift of 3.66 mmHg (variance 0.28) in the pressures measured by the IRRAflow{\textregistered} compared to 0.5 mmHg (variance 1.12) in the Raumedic measured pressures. Conclusion Bolting of the IRRAflow{\textregistered} catheter using the Medtronic Silverline{\textregistered} bolt is not recommendable. Increased irrigation rates are recommendable followed by a decrease in drainage bag level. ICP measurement using the IRRAflow{\textregistered} device was unreliable and should be accompanied by a control ICP monitor device in clinical settings.",

keywords = "Humans, Reproducibility of Results, Therapeutic Irrigation, Intracranial Pressure/physiology, Monitoring, Physiologic, Cerebral Hemorrhage/therapy, Hematoma",

author = "Mette Haldrup and Mojtaba Nazari and Chenghao Gu and Mads Rasmussen and Stig Dyrskog and {Ziegler Simonsen}, Claus and Mads Gr{\o}nh{\o}j and Poulsen, {Frantz Rom} and {Ur Rehman}, Naveed and {Rosendal Korshoej}, Anders",

note = "Copyright: {\textcopyright} 2024 Haldrup et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.",

year = "2024",

month = apr,

doi = "10.1371/journal.pone.0297131",

language = "English",

volume = "19",

journal = "PLOS ONE",

issn = "1932-6203",

publisher = "Public Library of Science",

number = "4 April",

}

Reliability and performance of the IRRAflow® system for intracranial lavage and evacuation of hematomas-A technical note. / Haldrup, Mette; Nazari, Mojtaba; Gu, Chenghao et al.
In: PLOS ONE, Vol. 19, No. 4 April, e0297131, 04.2024.

Research output: Contribution to journal/Conference contribution in journal/Contribution to newspaper › Journal article › Research › peer-review

TY - JOUR

T1 - Reliability and performance of the IRRAflow® system for intracranial lavage and evacuation of hematomas-A technical note

AU - Haldrup, Mette

AU - Nazari, Mojtaba

AU - Gu, Chenghao

AU - Rasmussen, Mads

AU - Dyrskog, Stig

AU - Ziegler Simonsen, Claus

AU - Grønhøj, Mads

AU - Poulsen, Frantz Rom

AU - Ur Rehman, Naveed

AU - Rosendal Korshoej, Anders

N1 - Copyright: © 2024 Haldrup et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

PY - 2024/4

Y1 - 2024/4

N2 - Background Intraventricular hemorrhage (IVH) is a severe condition with poor outcomes and high mortality. IRRAflow® (IRRAS AB) is a new technology introduced to accelerate IVH clearance by minimally invasive wash-out. The IRRAflow® system performs active and controlled intracranial irrigation and aspiration with physiological saline, while simultaneously monitoring and maintaining a stable intracranial pressure (ICP). We addressed important aspects of the device implementation and intracranial lavage. Method To allow versatile investigation of multiple device parameters, we designed an ex vivo lab setup. We evaluated 1) compatibility between the IRRAflow® catheter and the Silverline f10 bolt (Spiegelberg), 2) the physiological and hydrodynamic effects of varying the IRRAflow® settings, 3) the accuracy of the IRRAflow® injection volumes, and 4) the reliability of the internal ICP monitor of the IRRAflow®. Results The IRRAflow® catheter was not compatible with Silverline bolt fixation, which was associated with leakage and obstruction. Design space exploration of IRRAflow® settings revealed that appropriate settings included irrigation rate 20 ml/h with a drainage bag height at 0 cm, irrigation rate 90 ml/h with a drainage bag height at 19 cm and irrigation rate 180 ml/h with a drainage bag height at 29 cm. We found the injection volume performed by the IRRAflow® to be stable and reliable, while the internal ICP monitor was compromised in several ways. We observed a significant mean drift difference of 3.16 mmHg (variance 0.4, p = 0.05) over a 24-hour test period with a mean 24-hour drift of 3.66 mmHg (variance 0.28) in the pressures measured by the IRRAflow® compared to 0.5 mmHg (variance 1.12) in the Raumedic measured pressures. Conclusion Bolting of the IRRAflow® catheter using the Medtronic Silverline® bolt is not recommendable. Increased irrigation rates are recommendable followed by a decrease in drainage bag level. ICP measurement using the IRRAflow® device was unreliable and should be accompanied by a control ICP monitor device in clinical settings.

AB - Background Intraventricular hemorrhage (IVH) is a severe condition with poor outcomes and high mortality. IRRAflow® (IRRAS AB) is a new technology introduced to accelerate IVH clearance by minimally invasive wash-out. The IRRAflow® system performs active and controlled intracranial irrigation and aspiration with physiological saline, while simultaneously monitoring and maintaining a stable intracranial pressure (ICP). We addressed important aspects of the device implementation and intracranial lavage. Method To allow versatile investigation of multiple device parameters, we designed an ex vivo lab setup. We evaluated 1) compatibility between the IRRAflow® catheter and the Silverline f10 bolt (Spiegelberg), 2) the physiological and hydrodynamic effects of varying the IRRAflow® settings, 3) the accuracy of the IRRAflow® injection volumes, and 4) the reliability of the internal ICP monitor of the IRRAflow®. Results The IRRAflow® catheter was not compatible with Silverline bolt fixation, which was associated with leakage and obstruction. Design space exploration of IRRAflow® settings revealed that appropriate settings included irrigation rate 20 ml/h with a drainage bag height at 0 cm, irrigation rate 90 ml/h with a drainage bag height at 19 cm and irrigation rate 180 ml/h with a drainage bag height at 29 cm. We found the injection volume performed by the IRRAflow® to be stable and reliable, while the internal ICP monitor was compromised in several ways. We observed a significant mean drift difference of 3.16 mmHg (variance 0.4, p = 0.05) over a 24-hour test period with a mean 24-hour drift of 3.66 mmHg (variance 0.28) in the pressures measured by the IRRAflow® compared to 0.5 mmHg (variance 1.12) in the Raumedic measured pressures. Conclusion Bolting of the IRRAflow® catheter using the Medtronic Silverline® bolt is not recommendable. Increased irrigation rates are recommendable followed by a decrease in drainage bag level. ICP measurement using the IRRAflow® device was unreliable and should be accompanied by a control ICP monitor device in clinical settings.

KW - Humans

KW - Reproducibility of Results

KW - Therapeutic Irrigation

KW - Intracranial Pressure/physiology

KW - Monitoring, Physiologic

KW - Cerebral Hemorrhage/therapy

KW - Hematoma

UR - http://www.scopus.com/inward/record.url?scp=85190737620&partnerID=8YFLogxK

U2 - 10.1371/journal.pone.0297131

DO - 10.1371/journal.pone.0297131

M3 - Journal article

C2 - 38626156

SN - 1932-6203

VL - 19

JO - PLOS ONE

JF - PLOS ONE

IS - 4 April

M1 - e0297131

ER -

Reliability and performance of the IRRAflow® system for intracranial lavage and evacuation of hematomas-A technical note

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Keywords

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