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Data Collection for Noninvasive and Continuous Hemoglobin (SpHb) Monitoring in the Neonatal and Pediatric Patient Population
Study ID: STU-2021-0636
Summary
The primary objective of this clinical investigation is to collect data in the infants and small children population for continued development of Masimo's continuous SpHb technology. This is a prospective single-arm study design in neonatal and pediatric patients undergoing an elective surgical procedure. noninvasive SpHb measurements will be obtained and invasive blood samples will be analyzed using one or more reference methods. as the study is designed for data collection only for product development, there are no clinical study endpoints. up to 100 subjects ages 1 month to 6 years old with diversified demographics will be recruited and enrolled at this site with the following inclusion and exclusion criteria. inclusion Criteria * Patients undergoing general anesthesia, who are 1 month to 6 years old * Patients who weigh [GreaterThanorequalTo] 3 kg * Patients who are classified as american Society of anesthesiologists (aSa) physical status i, ii or iii. * Patients have an arterial or peripheral line in place * Patients who are admitted to the oR exclusion Criteria * Subjects with skin abnormalities at the planned application sites that may interfere with sensor application, per directions-for-use (DFu) or trans-illumination of the site, such as burns, scar tissue, nail polish, acrylic nails, infections, abnormalities, etc. * american Society of anesthesiologists (aSa) physical status iV * Subjects deemed unsuitable for the study at the discretion of the investigator each individual patient will participate only for the duration of their elective surgical procedure. The study enrollment period is anticipated to be approximately 12 to 24 months.
- Cancer Related
- No
- Healthy Volunteers
- No
- UT Southwestern Principal Investigator
- PETER SZMUK
MASIMO CORPORATION
Masimo Corporation is the developer of noninvasive technologies for the measurement and monitoring of physiological variables, such as arterial oxygen saturation (Spo2), total hemoglobin concentration (SpHb), carboxyhemoglobin concentration (SpCo), methemoglobin concentration (SpMet), acoustic respiration rate monitoring (RaM), end tidal Co2 (etCo2), temperature, and other physiological variables. Hemoglobin concentration in patients is a valuable blood reference used by clinicians when making healthcare decisions. Hemoglobin concentration can be used to indicate the need for blood transfusion and is one of the indicators of other related pathologies. For surgical patients, hemoglobin concentration is required for the assessment of blood loss, the need for blood transfusion or as preoperative indicator for the optimization of the patient status. The hemoglobin concentration is currently obtained by venipuncture or drawing a blood sample from an arterial line. often an arterial line is placed intra-operatively for the purpose of tracking hemoglobin concentrations in surgeries that are prone to major blood loss. Besides the patient discomfort there are additional potential risks and disadvantages associated with arterial line placement. Some of these are infection of the site, dangers of dealing with blood products, delay with diagnosis, and low update rate and cost. Thus, having a noninvasive monitor for the detection of hemoglobin concentrations has a clear benefit. The Masimo rainbow technology uses infrared and near-infrared light and calculates hemoglobin concentrations according to the hemoglobin's absorption of the light. This technology is similar to that of pulse oximetry. noninvasive measurement of total hemoglobin can potentially offer a great clinical value and provide a simple, portable, safe and accurate method for monitoring patients. Given that it is noninvasive and its ability to provide continuous, hemoglobin (SpHb) monitoring offers a new paradigm and opens up new possibilities for improved patient care. Masimo has received FDa 510(k) clearance for its noninvasive hemoglobin (SpHb) feature in multiple devices including the Rad-67, Radical-7, and Pronto for the noninvasive measurement of total hemoglobin (SpHb[RegisteredTM]) and Masimo SeT measurements of oxygen saturation (Spo2), pulse rate (PR), perfusion index (Pi), and respiration rate (RRa). The SpHb feature analyzes multiple wavelengths of light that pass through the subject's finger to non-invasively provide a hemoglobin concentration. To evaluate the accuracy of hemoglobin measurement, data collection and analysis of blood should be conducted in a controlled manner to reduce variability between noninvasive hemoglobin readings to the hemoglobin value obtained from a reference sample. Small differences in the processing and/or handling of hemoglobin may have dramatic effects in analytical reliability and reproducibility. Therefore, potential bias and confounding factors should be minimized as much as possible by having consistent technique of clinician, posture of the patient, timing of samples, etc. The devices used in the study have been FDa cleared for use in adults, pediatrics and neonates. The aim of this study is to collect additional hemoglobin data specifically in the neonatal and pediatric patient population in order to continue development of Masimo's continuous SpHb technology.