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The New MIRUS System for Short-Term Sedation in Postsurgical ICU Patients*

Romagnoli, Stefano MD1; Chelazzi, Cosimo MD, PhD1; Villa, Gianluca MD1; Zagli, Giovanni MD, PhD1; Benvenuti, Francesco MD1; Mancinelli, Paola MD1; Arcangeli, Giulio MD2; Dugheri, Stefano BS2; Bonari, Alessandro BS2; Tofani, Lorenzo3; Belardinelli, Andrea4; De Gaudio, A. Raffaele MD1

doi: 10.1097/CCM.0000000000002465
Online Clinical Investigations
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Objectives: To evaluate the feasibility and safety of the MIRUS system (Pall International, Sarl, Fribourg, Switzerland) for sedation with sevoflurane for postsurgical ICU patients and to evaluate atmospheric pollution during sedation.

Design: Prospective interventional study.

Setting: Surgical ICU. February 2016 to December 2016.

Patients: Postsurgical patients requiring ICU admission, mechanical ventilation, and sedation.

Interventions: Sevoflurane was administered with the MIRUS system targeted to a Richmond Agitation Sedation Scale from –3 to –5 by adaptation of minimum alveolar concentration.

Measurements and Main Results: Data collected included Richmond Agitation Sedation Scale, minimum alveolar concentration, inspired and expired sevoflurane fraction, wake-up times, duration of sedation, sevoflurane consumption, respiratory and hemodynamic data, Simplified Acute Physiology Score II, Sepsis-related Organ Failure Assessment, and laboratory data and biomarkers of organ injury. Atmospheric pollution was monitored at different sites: before sevoflurane delivery (baseline) and during sedation with the probe 15 cm up to the MIRUS system (S1) and 15 cm from the filter-Reflector group (S2). Sixty-two patients were enrolled in the study. No technical failure occurred. Median Richmond Agitation Sedation Scale was –4.5 (interquartile range, –5 to –3.6) with sevoflurane delivered at a median minimum alveolar concentration of 0.45% (interquartile range, 0.4–0.53) yielding a mean inspiratory and expiratory concentrations of 0.79% (SD, 0.24) and 0.76% (SD, 0.18), respectively. Median awakening time was 4 minutes (2.2–5 min). Median duration of sevoflurane administration was 3.33 hours (2.33–5.75 hr), range 1–19 hours with a mean consumption of 7.89 mL/hr (SD, 2.99). Hemodynamics remained stable over the study period, and no laboratory data indicated liver or kidney injury or dysfunction. Median sevoflurane room air concentration was 0.10 parts per million (interquartile range, 0.07–0.15), 0.17 parts per million (interquartile range, 0.14–0.27), and 0.15 parts per million (interquartile range, 0.07–0.19) at baseline, S1, and S2, respectively.

Conclusions: The MIRUS system is a promising and safe alternative for short-term sedation with sevoflurane of ICU patients. Atmospheric pollution is largely below the recommended thresholds (< 5 parts per million). Studies extended to more heterogeneous population of patients undergoing longer duration of sedation are needed to confirm these observations.

1Department of Anesthesia and Intensive Care, University of Florence, Azienda Ospedaliero-Universitaria Careggi, Florence, Italy.

2Industrial Hygiene Laboratory, University of Florence, Azienda Ospedaliero-Universitaria Careggi, Florence, Italy.

3Department of Neurosciences, Psychology, Drug Research and Child Health, University of Florence, Florence, Italy.

4Department of Innovation, Quality and Control, Azienda Ospedaliero-Universitaria Careggi, Florence, Italy.

*See also p. 1580.

This work has been performed at Azienda Ospedaliero-Universitaria Careggi, Department of Anesthesia and Intensive Care, Florence, Italy.

Supported by Pall International (Sarl, Fribourg, Switzerland) by providing the MIRUS device and disposable materials. Pall International had no role in the study design, data collection or analysis, decision to publish, or preparation of the article. This does not alter our adherence to Critical Care Medicine policies.

Drs. Romagnoli, Chelazzi, Villa, Mancinelli, Dugheri, Bonari, Belardinelli, and De Gaudio disclosed that Pall International supported the study by providing the MIRUS device and disposable materials, but they had no role in study design, data collection and analysis, decision to publish, or preparation of the article. Dr. Romagnoli received funding from Baxter, Orion Pharma, and Vygon for lectures, from ICU Medical, MSD, and Medtronic grants for consultancy, from Baxter, BBraun, Pall International, and Vygon support for travel expenses, hotel accommodations, and registration to meetings. Dr. Chelazzi received a grant for consultancy by Astellas, support for meetings (travels, hotel accommodations, and/or registration) by BBraun, Astellas, MSD, Pfizer, Pall International, Baxter, and Orion Pharma, for lectures by Orion Pharma. Dr. Villa received funding from Baxter support for travel expenses, hotel accommodations, and registration to meetings. Dr. De Gaudio received research grants from MSD Italia, Baxter, and Pall International. The remaining authors have disclosed that they do not have any potential conflicts of interest.

Address requests for reprints to: Stefano Romagnoli, MD, Azienda Ospedaliero-Universitaria Careggi, Anestesia Oncologica e Terapia Intensiva, L.go Brambilla, 3, 50139. Florence, Italy. E-mail: stefano.romagnoli@unifi.it

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