Accurate Assessment of Blood Loss during Cesarean Delivery Improves Estimation of Postoperative Hemoglobin.

OBJECTIVE: To determine if accurate blood loss determination during cesarean delivery can improve the prediction of postoperative hemoglobin levels. STUDY DESIGN: This is a retrospective cohort study using visually estimated blood loss (traditional, n = 2,025) versus estimates using a mobile application that photographs sponges and canisters and calculates their hemoglobin content (device, n = 756). RESULTS: The correlation between the actual and predicted postoperative day 1 hemoglobin value (PPO1 Hgb) was better in the device group (R 2 = 0.519, correlation = 0.720) than in the traditional group (R 2 = 0.429, correlation = 0.655) (p = 0.005). For patients in the device group where the estimated blood loss was >1,000 mL (n = 53), the PPO1 Hgb was also better correlated with the actual value (R 2 = 0.319, correlation = 0.565) than the predictions using visually estimated blood loss for those patients in the device group whose visual estimation was >1,000 mL (n = 32) (R 2 = 0.035, correlation = 0.187) (p = 0.027). CONCLUSION: Implementation of a device that accurately measures blood loss allows for a better prediction of postoperative day 1 hemoglobin concentration than is possible using visual blood loss estimation. This improvement was seen in the entire patient group and was particularly prominent in patients with blood losses of > 1,000 mL.

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

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.

Clinical Experience with the Implementation of Accurate Measurement of Blood Loss during Cesarean Delivery: Influences on Hemorrhage Recognition and Allogeneic Transfusion.

OBJECTIVE: This article compares hemorrhage recognition and transfusion using accurate, contemporaneous blood loss measurement versus visual estimation during cesarean deliveries. STUDY DESIGN: A retrospective cohort study using visually estimated blood loss (traditional, n = 2,025) versus estimates using a mobile application that photographs sponges and canisters and calculates their hemoglobin content (device, n = 756). RESULTS: Blood loss > 1,000 mL was recognized in 1.9% of traditional visual estimation patients, while measured blood loss of > 1,000 mL occurred in 8.2% of device patients (p < 0.0001). In both groups, this was accompanied by a greater decrease in transfusion-adjusted hemoglobin levels than occurred in patients without hemorrhage (p < 0.0001). Despite similar transfusion rates (1.6% in both groups), fewer red cell units were given to transfused patients in the device group (1.83 ± 0.58 versus 2.56 ± 1.68 units; p = 0.038). None of the patients in the device group received plasma or cryoprecipitate. Seven patients in the traditional group received these products (p = 0.088). Device use was associated with shorter hospital stays (4.0 ± 2.3 versus 4.4 ± 2.9 days; p = 0.0006). CONCLUSION: The device identified hemorrhages more frequently than visual estimation. Device-detected hemorrhages appeared clinically relevant. Blood product transfusion was reduced possibly due to earlier recognition and treatment, although further studies are needed to verify the conclusion.

Real-time evaluation of an image analysis system for monitoring surgical hemoglobin loss.

Monitoring blood loss is important for management of surgical patients. This study reviews a device (Triton) that uses computer analysis of a photograph to estimate hemoglobin (Hb) mass present on surgical sponges. The device essentially does what a clinician does when trying to make a visual estimation of blood loss by looking at a sponge, albeit with less subjective variation. The performance of the Triton system is reported upon in during real-time use in surgical procedures. The cumulative Hb losses estimated using the Triton system for 50 enrolled patients were compared with reference Hb measurements during the first quarter, half, three-quarters and full duration of the surgery. Additionally, the estimated blood loss (EBL) was calculated using the Triton measured Hb loss and compared with values obtained from both visual estimation and gravimetric measurements. Hb loss measured by Triton correlated with the reference method across the four measurement intervals. Bias remained low and increased from 0.1 g in the first quarter to 3.7 g at case completion. The limits of agreement remained narrow and increased proportionally from the beginning to the end of the cases, reaching a maximum range of -15.3 to 22.7 g. The median (IQR) difference of EBL derived from the Triton system, gravimetric method and visual estimation versus the reference value were 13 (74), 389 (287), and 4 (230) mL, respectively. Use of the Triton system to measure Hb loss in real-time during surgery is feasible and accurate.

Ultrarapid Induction of Hypothermia Using Continuous Automated Peritoneal Lavage With Ice-Cold Fluids: Final Results of the Cooling for Cardiac Arrest or Acute ST-Elevation Myocardial Infarction Trial.

OBJECTIVES: Hypothermia (32-34 °C) can mitigate ischemic brain injury, and some evidence suggests that it can reduce infarct size in acute myocardial infarction and acute ischemic stroke. For some indications, speed of cooling may be crucial in determining efficacy. We performed a multicenter prospective intervention study to test an ultrarapid cooling technology, the Velomedix Automated Peritoneal Lavage System using ice-cold fluids continuously circulating through the peritoneal cavity to rapidly induce and maintain hypothermia in comatose patients after cardiac arrest and a small number of awake patients with acute myocardial infarction. DESIGN: Multicenter prospective intervention study. SETTING: Intensive care- and coronary care units of multiple tertiary referral centers. MEASUREMENTS AND MAIN RESULTS: Access to the peritoneal cavity was gained using a modified blunt dilating instrument, followed by catheter placement. Patients were cooled to a temperature of 32.5 °C, maintained for 24 hours (cardiac arrest) or 3 hours (acute myocardial infarction) followed by controlled rewarming. Forty-nine patients were enrolled, and 46 patients completed treatment. One placement was unsuccessful (abdominal wall not breached), two patients were ultimately not cooled, and only safety data are reported. Average catheter insertion time was 2.3 minutes. Mean time to temperature less than 33 °C was 10.4 minutes (average cooling rate, 14 °C/hr). Median infarct size in patients who had coronary interventions was 16% of LV. No cases of stent thrombosis occurred. Survival in cardiac arrest patients with initial rhythm of ventricular tachycardia/ventricular fibrillation was 56%, of whom 82 had a complete neurologic recovery. This compares favorably to outcomes from previous studies. CONCLUSION: Automated peritoneal lavage system is a safe and ultrarapid method to induce and maintain hypothermia, which appears feasible in cardiac arrest patients and awake patients with acute myocardial infarction. The shivering response appeared to be delayed and much reduced with this technology, diminishing metabolic disorders associated with cooling and minimizing sedation requirement. Our data suggest that ultrarapid cooling could prevent subtle neurologic damage compared with slower cooling. This will need to be confirmed in direct comparative studies.

Cameraless peritoneal entry in abdominal laparoscopy.

BACKGROUND AND OBJECTIVES: Despite significant advances in laparoscopic instrumentation and techniques, injury to intraabdominal structures remains a potentially serious complication of peritoneal access. Consensus on the best method to obtain peritoneal access is lacking. A safe technique that does not rely on direct visualization of the abdominal layers could shorten the learning curve for surgeons and potentially be adopted by other physicians for a variety of nonsurgical indications for peritoneal entry. METHODS: A prospective series of 99 consecutive patients who underwent upper-abdominal laparoscopic surgery performed by a single surgeon between January 2009 and June 2010 was reviewed. The method used to obtain peritoneal access was the fluid-based peritoneal entry indication technique (C-PET) with the EndoTIP trocar. RESULTS: Successful abdominal entry using C-PET was achieved in 90 (90.9%) of the patients; no trocar-related injuries or other injuries associated with peritoneal access occurred. The mean time from incision to confirmed peritoneal access was 21.4 s (range, 12 to 65). Of the 9 cases in which C-PET did not successfully gain entry, 6 occurred during the first 20 surgeries and only 3 in the final 79. CONCLUSIONS: C-PET is simple, safe, timely, and effective for gaining peritoneal access during laparoscopic abdominal surgeries. In this series, C-PET produced no complications and proved effective across a wide variety of patients, including the obese and those who had had previous surgery. Furthermore, C-PET does not require visual recognition of anatomic layers and potentially could easily be taught to nonsurgeon physicians who perform peritoneal access.

Prospective, multicenter, randomized, controlled pilot trial of peritoneal hypothermia in patients with ST-segment- elevation myocardial infarction.

BACKGROUND: Systemic hypothermia may reduce infarct size if established before reperfusion. The large surface area of the bowel may facilitate rapid hypothermia. We therefore examined the feasibility, safety, and efficacy of hypothermia induced by an automated peritoneal lavage system in patients with ST-segment-elevation myocardial infarction undergoing primary percutaneous coronary intervention. METHODS AND RESULTS: Patients with ST-segment-elevation myocardial infarction within 6 hours of symptom onset were randomized to peritoneal hypothermia before and for 3 hours after percutaneous coronary intervention versus control. The primary safety end point was the 30-day composite rate of death, reinfarction, ischemia-driven target vessel revascularization, major bleeding, sepsis, pneumonia, peritonitis, severe arrhythmia, or renal failure. The primary efficacy end point was infarct size assessed by cardiac MRI on day 3 to 5. Fifty-four patients were randomized at 7 centers to hypothermia (n=28) versus control (n=26). Hypothermia was successfully initiated in 96.3% of patients, and median [interquartile range] temperature at first balloon inflation was 34.7 [34.0-34.9]°C. Median door-to-balloon times in the hypothermia and control groups were 62 [51-81] and 47 [37-55] minutes, respectively (P=0.007). The primary safety end point occurred in 6 (21.4%) and 0 (0%) patients in the hypothermia and control groups, respectively (P=0.01), including 3 versus 0 stent thrombosis events. Infarct size was 17.2% [15.1-20.6] and 16.1% [10.0-22.2] in the hypothermia and control groups, respectively (P=0.54). CONCLUSIONS: Peritoneal hypothermia is feasible and achieves rapid cooling with only a modest increase in treatment times in the setting of ST-segment-elevation myocardial infarction. However, in the present randomized trial, peritoneal hypothermia was associated with an increased rate of adverse events without reducing infarct size. CLINICAL TRIAL REGISTRATION URL: http://www.clinicaltrials.gov. Unique identifier: NCT01655433.