Evaluation of sepsis using compensatory reserve measurement: A prospective clinical trial

Abstract

BACKGROUND Sepsis, a leading cause of morbidity and mortality worldwide, characterized by metabolic and hemodynamic changes that can lead to multiorgan failure and death. The evaluation of a patient's condition is routinely performed by several objective criteria. The compensatory reserve measurement (CRM) represents a new paradigm that measures the total of all physiological compensatory mechanisms, using noninvasive photoplethysmography to read changes in arterial waveforms. The present study's aim was to evaluate the applicability and the predictive value of the CRM during sepsis. METHODS Data were prospectively collected from patients hospitalized in the department of surgery because of different inflammatory illnesses. All subjects were evaluated with hemodynamic, laboratory measurements and CRM throughout hospitalization. RESULTS Of 100 subjects enrolled, 84 patients were not septic. The remaining 16 patients were in sepsis (Sequential Organ Failure Assessment [SOFA] score, >2), 6 of whom were in septic shock and 4 died. When nonseptic patients were compared with septic patients, statistical differences were found in C-reactive protein level (p < 0.0005), SOFA score (p < 0.0005), and CRM (p < 0.0001). Other parameters did not show any difference between groups. The area under the receiver operating characteristic curve for CRM was 1, significantly higher than the area under the receiver operating characteristic for heart rate (0.78), systolic blood pressure (0.67), quick SOFA (0.81), and respiratory rate (0.56). CONCLUSION Clinical criteria, imaging, and laboratory features used to identify a septic patient are suboptimal. This demonstrates the need for a monitoring device capable of detecting rapidly, constantly, and simply the sum condition of the ill patient. We have shown that CRM was able to distinguish between severe septic and nonseptic patients early in the course of hospitalization and was significantly more sensitive than the conventional diagnostic tools. Such capability to assess the septic patients or even to triage these patients will surely aid treatment of sepsis. LEVEL OF EVIDENCE Care management, level II.

Efficacy of the compensatory reserve measurement in an emergency department trauma population

“…We successfully enrolled 90 patients with reliable analog waveform data, making this the first clinical investigation to capture continuous data for the calculation of CRM compared with previous studies that relied on intermittent measurements. [27][28][29][30] Consistent with results reported in previous studies, most of our subjects were male and suffered from injuries secondary to blunt trauma, with motor vehicle collisions making up the largest proportion. 3 Two significant observations manifested from our dataset.…”

The compensatory reserve: potential for accurate individualized goal‐directed whole blood resuscitation

“…When patients with gastrointestinal bleeding required red blood cell transfusion, a nearly 11% increase in CRM was associated with a 22% increase in hemoglobin . CRM has consistently shown accuracy in assessing fluid interventions when applied during resuscitative treatment of hemorrhage in patients suffering from Dengue hemorrhagic fever, blunt or penetrating trauma with significant blood loss, internal bleeding, and sepsis or septic shock . With these clinical data taken together with the relationship between CRM and DO 2 presented in this review, the sensitivity of CRM in patients with lowered circulating red blood cells supports the notion that anemia may act as a trigger to support the need for transfusion therapy.…”

“…Moreover, a critical DO 2 value of 5.3 mL O 2 ∙kg −1 ∙min −1 calculated from the non‐human primate data appears to be a reasonable value for humans since it meets the criteria of being less than 7.3 and given the striking similarity in the average response of CR between human and non‐human primates during progressive stepwise reductions in central blood volume . The translation of critical DO 2 to CRM in trauma patients is supported by the first clinically‐available data showing the CRM becoming 0% at the point in time for four trauma patients in septic shock who went on to die …”

Compensatory reserve detects subclinical shock with more expeditious prediction for need of life‐saving interventions compared to systolic blood pressure and blood lactate

“…The specificity of a machine‐learning approach allows the CRM to overcome many of these monitoring limitations because the algorithm is based on a database of more than 650,000 waveforms that includes a wide demographic of age (18–55 years), sex, fitness, and body mass (BMI range = 17.3–39.4 kg/m 2 ) in a population of greater than 250 healthy humans 11, 12, 24, 26 . The capability of the algorithm to “learn” to recognize the physiology of progression to decompensated shock in healthy humans has provided a basis for the algorithm to consistently recognize the compensatory status of trauma patients with pathophysiology 12, 19‐22, 27 …”

“…As such, identification of compensated shock during the early subclinical phase could potentially facilitate improved clinical decision making and accelerate the provision of life‐saving interventions (LSIs). In this regard, the compensatory reserve measurement (CRM) has been consistently shown to reflect early stages of physiological compensation with greater sensitivity and specificity than standard vital signs in conditions of experimentally induced central hypovolemia, 11‐15 controlled human blood loss, 16‐18 and trauma patients with hemorrhage 19‐22 . In the present clinical investigation, we captured for the first time CRM of trauma patients at progressive stages from a state of subclinical shock to overt hemorrhagic shock.…”