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

PLoS One. 2024 Apr 16;19(4):e0297131. doi: 10.1371/journal.pone.0297131. eCollection 2024.

Authors

Mette Haldrup¹, Mojtaba Nazari², Chenghao Gu¹, Mads Rasmussen^{3

4}, Stig Dyrskog⁵, Claus Ziegler Simonsen^{5

6}, Mads Grønhøj⁷, Frantz Rom Poulsen⁷, Naveed Ur Rehman², Anders Rosendal Korshoej^{1

3}

Affiliations

¹ Department of Neurosurgery, Aarhus University Hospital, Aarhus N, Denmark.
² Department of Engineering, Electrical and Computer Engineering, Aarhus University, Aarhus N, Denmark.
³ Department of Clinical Medicine, Aarhus University, Aarhus N, Denmark.
⁴ Department of Anesthesiology, Section of Neuroanesthesia, Aarhus University Hospital, Aarhus, Denmark.
⁵ Department of Intensive Care, Aarhus University Hospital, Aarhus N, Denmark.
⁶ Department of Neurology, Aarhus University Hospital, Aarhus N, Denmark.
⁷ Department of Neurosurgery, Odense University Hospital, Odense, Denmark.

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.

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.

MeSH terms

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

Grants and funding

ARK, MHJ Aarhus University provided funding in the order of 1,800,000 DKK supporting the PhD study associated with the trial and a grant support was received from IRRAS, 2,857,000 m DKK in the course of the study period. The trial protocol was designed by sponsor-investigator Aarhus University Hospital. The funding bodies have peer reviewed the trial protocol but have had no role in the design of the study, in the analysis, and interpretation of data or in the writing of this manuscripts.