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In Vitro Evaluation of a Novel Image Processing Device to Estimate Surgical Blood Loss in Suction Canisters

Konig, Gerhardt, MD*; Waters, Jonathan, H., MD†,‡; Hsieh, Eric, BS§; Philip, Bridget, MD; Ting, Vicki, MD; Abbi, Gaurav, MD#; Javidroozi, Mazyar, MD, PhD**; Tully, Griffeth, W., MD§; Adams, Gregg, MD††

doi: 10.1213/ANE.0000000000002692
Blood Management: Original Clinical Research Report

BACKGROUND: Clinicians are tasked with monitoring surgical blood loss. Unfortunately, there is no reliable method available to assure an accurate result. Most blood lost during surgery ends up on surgical sponges and within suction canisters. A novel Food and Drug Administration–cleared device (Triton system; Gauss Surgical, Inc, Los Altos, CA) to measure the amount of blood present on sponges using computer image analysis has been previously described. This study reports on performance of a complementary Food and Drug Administration–cleared device (Triton Canister System; Gauss Surgical, Inc, Los Altos, CA) that uses similar image analysis to measure the amount of blood in suction canisters.

METHODS: Known quantities of expired donated whole blood, packed red blood cells, and plasma, in conjunction with various amounts of normal saline, were used to create 207 samples representing a wide range of blood dilutions commonly seen in suction canisters. Each sample was measured by the Triton device under 3 operating room lighting conditions (bright, medium, and dark) meant to represent a reasonable range, resulting in a total of 621 measurements. Using the Bland–Altman method, the measured hemoglobin (Hb) mass in each sample was compared to the results obtained using a standard laboratory assay as a reference value. The analysis was performed separately for samples measured under each lighting condition. It was expected that under each separate lighting condition, the device would measure the various samples within a prespecified clinically significant Hb mass range (±30 g per canister).

RESULTS: The limits of agreement (LOA) between the device and the reference method for dark (bias: 4.7 g [95% confidence interval {CI}, 3.8–5.6 g]; LOA: −8.1 g [95% CI, −9.7 to −6.6 g] to 17.6 g [95% CI, 16.0–19.1 g]), medium (bias: 3.4 g [95% CI, 2.6–4.1 g]; LOA: −7.4 g [95% CI, −8.7 to −6.1 g] to 14.2 g [95% CI, 12.9–15.5 g]), and bright lighting conditions (bias: 4.1 g [95% CI, 3.2–4.9 g]; LOA: −7.6 g [95% CI, −9.0 to −6.2 g] to 15.7 g [95% CI, 14.3–17.1 g]) fell well within the predetermined clinically significant limits of ±30 g. Repeated measurements of the samples under the various lighting conditions were highly correlated with intraclass correlation coefficient of 0.995 (95% CI, 0.993–0.996; P < .001), showing that lighting conditions did not have a significant impact on measurements. Hb mass bias was significantly associated with hemolysis level (Spearman ρ correlation coefficient, −0.137; P = .001) and total canister volume (Spearman ρ correlation coefficient, 0.135; P = .001), but not ambient illuminance.

CONCLUSIONS: The Triton Canister System was able to measure the Hb mass reliably with clinically acceptable accuracy in reconstituted blood samples representing a wide range of Hb concentrations, dilutions, hemolysis, and ambient lighting settings.

Published ahead of print December 11, 2017.

From the Departments of *Anesthesiology

Anesthesiology and Bioengineering, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania

McGowan Institute for Regenerative Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania

§Gauss Surgical, Inc, Los Altos, California

Departments of Anesthesiology

Obstetrics

#Orthopedics, Santa Clara Valley Medical Center, San Jose, California

**Englewood Hospital and Medical Center, Englewood, New Jersey

††Department of Surgery, Santa Clara Valley Medical Center, San Jose, California.

Published ahead of print December 11, 2017.

Accepted for publication October 20, 2017.

Funding: This research was supported by a grant from the National Institutes of Health (T32GM075770). Equipment for study was provided by Gauss Surgical, Inc, Los Altos, California.

Conflicts of Interest: See Disclosures at the end of the article.

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Institutional review board: This study was approved by the institutional review board of Santa Clara Valley Medical Center, San Jose, CA.

Reprints will not be available from the authors.

Address correspondence to Gerhardt Konig, MD, Department of Anesthesiology, University of Pittsburgh School of Medicine, Magee Womens Hospital, 300 Halket St, Suite 3510, Pittsburgh, PA 15213. Address e-mail to konigg@upmc.edu.

© 2018 International Anesthesia Research Society
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