NON-INVASIVE HEMOGLOBIN (SPHB) MEASUREMENT VIA PULSE CO-OXIMETRY ON PEDIATRIC SUBJECTS

Study ID
STU 022012-092

Cancer Related
No

Healthy Volunteers
No

Study Sites

  • Children's Medical Center-Dallas

Contact
Joanna Dela Cruz
214-456-6393
joanna.delacruz@utsouthwestern.edu

Principal Investigator
Peter Szmuk

Summary

at the start of each surgical case the research personnel will apply sensor(s), shield(s), and begin data collection. Masimo recommends attaching sensor(s) to a digit on the same arm as the blood draw. The digit to be used should be in this order, from most preferred to least preferred:
1) Middle and ring finger of the non-dominant hand
2) Middle and ring finger of the dominant hand
3) index finger of non-dominant hand
4) index finger of the dominant hand

once the appropriate digit is selected, apply sensor(s) to patient using best practices. Rest patient's hand with sensor(s) on a horizontal surface (hand should not hang in space). Secure sensor(s) cable to patient's arm with tape. Place light shield(s) over sensor(s) to block ambient light. note all events that may impact hemoglobin measurement. Record these observations and the exact time they occur on the electronic case report. Collect blood sample(s) every 1, 2 hours (not to exceed the maximum blood volumes withdrawn per Children' Medical Center Clinical Practice Policy no. 2.11) during each surgery. The number of blood samples will be guided by the clinical requirements during high potential bleeding surgeries.

once blood sample is collected, mix blood carefully after filling the vacutainer(s) by rotating it gently at least 10 times. Blood sample(s) are to be analyzed by Children's Medical Center Central Laboratory. an additional 1 ml sample may be de-identified and sent to sponsor for further hemoglobin testing using HiCn and coulter methods. Document on the electronic case report, the actual time the blood came out of the patient and the time the tHb came back from the laboratory. in addition, document surgery related events. (start and stop time of case, administration of oxygen, drugs, fluids and blood products, time of blood draw and laboratory hemoglobin concentration).

upon completion of the surgical case, upload data collected from the Masimo Radical - 7 device and electronic case report to Masimo data collection FTP server. no patient identifier information is to be recorded onto the eCRF

Patients will be screened, consented and enrolled preoperatively according to the following inclusion and exclusion criteria:

inclusion criteria:
1. Patients who are neonates to 18 years of age
2. Patients scheduled for surgical procedures with a high risk of bleeding (craniotomy, craniosynostosis, major abdominal, thoracic and orthopedic surgery) where an arterial line will be used for blood pressure monitoring and frequent blood sampling
3. Patients scheduled for surgical procedures with a moderate risk of bleeding where a peripheral intravenous line will be used for blood sampling
4. only patients with written informed consent signed by parents or legal guardians will be enrolled
5. in children 10 and older patient's assent will be obtained

exclusion criteria:
1. Patients who are unable to give their consent and/or assent
2. Subject has skin abnormalities affecting the digits such as psoriasis, eczema, angioma, scar tissue, burn, fungal infection, substantial skin breakdown, nail polish or acrylic nails that would prevent monitoring of Spo2 levels during the study.
3. Subject has any medical condition, which in the judgment of the investigator renders them inappropriate for participation in this study.

Participant Eligibility

1. Patients who are neonates to 18 years of age
2. Patients scheduled for surgical procedures with a high risk of bleeding (craniotomy, craniosynostosis, major abdominal, thoracic and orthopedic surgery) where an arterial line will be used for blood pressure monitoring and frequent blood sampling; patients with peripheral intravenous lines may be included
3. Only patients with written informed consent signed by parents or legal guardians will be enrolled
4. In children 10 and older patient[Single Quote]s assent will be obtained