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Accuracy of the Nova StatStrip® glucometer in patients undergoing major abdominal surgery: an observational study

Précision du glucomètre StatStrip® de Nova chez la patientèle bénéficiant d’une chirurgie abdominale majeure : une étude observationnelle

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Canadian Journal of Anesthesia/Journal canadien d'anesthésie Aims and scope Submit manuscript

Abstract

Purpose

While the Nova StatStrip® Glucose Hospital Meter System (Nova Biomedical, Waltham, MA, USA) is approved for point-of-care testing (POCT) in critically ill patients, its use during major abdominal surgery has not been evaluated. The purpose of this study was to assess the accuracy of the Nova StatStrip glucometer in patients undergoing major hepatobiliary procedures using the Parkes error grid (ISO15197:2013) and criteria defined by the Clinical and Laboratory Standards Institute (CLSI) POCT12-A3 guideline.

Methods

This study was a post hoc exploratory study of patients participating in a prospective randomized controlled trial on the effects of hyperinsulinemic normoglycemia (HNC) on infectious outcomes after hepatobiliary surgery. Arterial blood samples were collected before surgery and one hour, two hours, and three hours after baseline. Blood glucose levels were analyzed by the Nova StatStrip glucometer and the GEM® PremierTM 5000 blood gas analyzer. Accuracy of the StatStrip glucometer was assessed using the Parkes error grid for type 1 diabetes mellitus (when 99% of samples were within zones A and B on the Parkes error grid and clinical accuracy was acceptable) and the CLSI POCT12-A3 criteria.

Results

Blood glucose levels were analyzed in 135 patients, 70 of whom received the HNC. In the Parkes error grid plotted, all samples at all time-points were within zones A and B. The Nova StatStrip glucometer also satisfied CLSI POCT12-A3 criteria at all time-points.

Conclusion

The Nova StatStrip glucometer was accurate in patients undergoing major upper abdominal surgery, independent of the administration of high-dose insulin therapy.

Study registration

ClinicalTrials.gov (NCT01528189); registered 7 February 2012.

Résumé

Objectif

Bien que le système hospitalier de lecture de la glycémie StatStrip® de Nova (Nova Biomedical, Waltham, MA, É.-U.) soit approuvé pour une utilisation au chevet (ou POCT, pour ‘Point of Care Testing’) chez la patientèle en état critique, son utilisation n’a pas été évaluée en chirurgie abdominale majeure. L’objectif de cette étude était d’évaluer la précision du glucomètre StatStrip de Nova chez la patientèle bénéficiant d’interventions hépatobiliaires majeures à l’aide de la grille d’erreur de Parkes (ISO15197:2013) et des critères définis par la directive POCT12-A3 du Clinical and Laboratory Standards Institute (CLSI).

Méthode

Il s’agissait d’une étude exploratoire post-hoc auprès de patient·es participant à une étude randomisée contrôlée prospective sur les effets de la normoglycémie hyperinsulinémique (HNC) sur les issues infectieuses après une chirurgie hépatobiliaire. Des échantillons de sang artériel ont été prélevés avant la chirurgie et une heure, deux heures et trois heures après l’échantillon initial. Les taux de glycémie ont été analysés avec le glucomètre StatStrip de Nova et l’analyseur de gaz sanguin GEM® PremierTM 5000. La précision du glucomètre StatStrip a été évaluée à l’aide de la grille d’erreur de Parkes pour le diabète sucré de type 1 (lorsque 99 % des échantillons se trouvaient dans les zones A et B de la grille d’erreur de Parkes et que la précision clinique était acceptable) et des critères POCT12-A3 du CLSI.

Résultats

La glycémie a été analysée chez 135 personnes, dont 70 ont reçu une normoglycémie hyperinsulinémique. Dans la grille d’erreur de Parkes tracée, tous les échantillons à tous les points temporels se trouvaient dans les zones A et B. Le glucomètre StatStrip de Nova a également satisfait aux critères POCT12-A3 du CLSI à tous les points temporels.

Conclusion

Le glucomètre StatStrip de Nova était précis chez la patientèle bénéficiant d’une chirurgie abdominale supérieure majeure, indépendamment de l’administration d’insulinothérapie à forte dose.

Enregistrement de l’étude

ClinicalTrials.gov (NCT01528189); enregistrée le 7 février 2012.

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Author contributions

Keisuke Omiya contributed to the acquisition, analysis, and interpretation of data, and drafting the article. Yosuke Nakadate and Hiroaki Sato contributed to conception and design of the study, and analysis and interpretation of data. Bon-Wook Koo contributed to conception and design of the study, and the acquisition and interpretation of data. Thomas Schricker contributed to conception and design of the study, analysis and interpretation of data, and drafting the article.

Disclosures

All authors declare that they have no financial or nonfinancial interests that may be relevant to the submitted work.

Funding statement

This study was supported by funds provided by the Department of Anesthesia at the Royal Victoria Hospital, McGill University Health Centre and McGill University.

Editorial responsibility

This submission was handled by Dr. Stephan K. W. Schwarz, Editor-in-Chief, Canadian Journal of Anesthesia/Journal canadien d’anesthésie.

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Authors and Affiliations

  1. Department of Anesthesia, McGill University Health Centre, Royal Victoria Hospital–Glen Site, Montreal, QC, Canada

    Keisuke Omiya MD, Hiroaki Sato MD, PhD, Bon-Wook Koo MD, PhD & Thomas Schricker MD, PhD

  2. Department of Anesthesiology, University of Tsukuba Hospital, Tsukuba, Ibaraki, Japan

    Yosuke Nakadate MD, PhD

  3. Department of Anesthesia, McGill University Health Centre, Royal Victoria Hospital–Glen Site, 1001 Decarie Blvd., Montreal, QC, H4A 3J1, Canada

    Keisuke Omiya MD

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  1. Keisuke Omiya MD
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  2. Yosuke Nakadate MD, PhD
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  4. Bon-Wook Koo MD, PhD
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  5. Thomas Schricker MD, PhD
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Correspondence to Keisuke Omiya MD.

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Omiya, K., Nakadate, Y., Sato, H. et al. Accuracy of the Nova StatStrip® glucometer in patients undergoing major abdominal surgery: an observational study. Can J Anesth/J Can Anesth 70, 1970–1977 (2023). https://doi.org/10.1007/s12630-023-02606-z

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  • DOI: https://doi.org/10.1007/s12630-023-02606-z

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