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The aim of this study is to assess the ability of the Triton Device to measure blood loss among women undergoing elective and non-elective cesarean delivery. This patient population often experiences significant blood loss during surgery, and measurements of surgical blood loss are often inaccurate.
This is an observational study. Potential participants will be approached by a member of the research team prior to surgery. Healthy ASA 1, 2, or 3 patients undergoing uncomplicated Cesarean delivery will be recruited. The Triton device will be used during the surgery to estimate blood loss. Specifically, the device takes pictures of the blood saturated laps and fluid collection canister and calculates hemoglobin loss and overall blood loss.
Serum hemoglobin samples will be collected at baseline on presentation to the pre-operative area, within 15 mins of arrival in PACU and at 24 hrs post cesarean delivery. Blood sampling will take place by venipuncture technique from a vein in the arm. Maternal vital signs during the perioperative period (heart rate, maternal mean arterial blood pressure, anesthetic technique, fluid administration, and surgical data will be recorded.
All patient will have a neuraxial anesthetic of a spinal or combined spinal/epidural. Fluid administration will be under the discretion of the anesthesiologist and will follow standard guidelines including 1L of Lactated Ringers co-load at time of spinal and 1-2L of crystaloid intraoperatively.
At the end of the cesarean section, the following measurements will be made:
Using mixed effects modeling, we will determine whether estimated blood loss measurements using Triton (tEBL) can be used to predict postpartum hemoglobin (Hb) levels, after accounting for the predelivery Hb level, intraoperative intravenous fluids and patient/operative factors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cesarean Section Group | Patients undergoing cesarean section |
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| Measure | Description | Time Frame |
|---|---|---|
| Difference in blood loss measurements | Compare blood loss estimates between the triton device, visual estimation of blood loss, and cumulative measurements of blood loss during a cesarean delivery | Day Of Surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Triton Blood Loss Prediction of Post Partum Hemoglobin | Using mixed effects modeling, it will be determine whether estimated blood loss measurements using Triton (tEBL) can be used to predict postpartum hemoglobin (Hb) levels, after accounting for the predelivery Hb level, intraoperative intravenous fluids and patient/operative factors. | 24-48 hours post surgery |
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Inclusion Criteria:
Exclusion Criteria:
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Healthy female patients undergoing uncomplicated Cesarean delivery
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| Name | Affiliation | Role |
|---|---|---|
| Alexander J Butwick, FRCA | Stanford University | Principal Investigator |
| Brendan Carvalho, MBBCh, FRCA | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lucille Packard Children's Hospital | Palo Alto | California | 94305 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20508942 | Background | Al Kadri HM, Al Anazi BK, Tamim HM. Visual estimation versus gravimetric measurement of postpartum blood loss: a prospective cohort study. Arch Gynecol Obstet. 2011 Jun;283(6):1207-13. doi: 10.1007/s00404-010-1522-1. Epub 2010 May 28. | |
| 24806138 | Background | Konig G, Holmes AA, Garcia R, Mendoza JM, Javidroozi M, Satish S, Waters JH. In vitro evaluation of a novel system for monitoring surgical hemoglobin loss. Anesth Analg. 2014 Sep;119(3):595-600. doi: 10.1213/ANE.0000000000000198. |
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| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 24797122 | Background | Holmes AA, Konig G, Ting V, Philip B, Puzio T, Satish S, Waters JH. Clinical evaluation of a novel system for monitoring surgical hemoglobin loss. Anesth Analg. 2014 Sep;119(3):588-594. doi: 10.1213/ANE.0000000000000181. |
| 29847380 | Derived | Fedoruk K, Seligman KM, Carvalho B, Butwick AJ. Assessing the Association Between Blood Loss and Postoperative Hemoglobin After Cesarean Delivery: A Prospective Study of 4 Blood Loss Measurement Modalities. Anesth Analg. 2019 May;128(5):926-932. doi: 10.1213/ANE.0000000000003449. |