Lucille Packard Children's Hospital
Palo Alto, California, 94305, United States
NCT Number: NCT02667600
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.
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Notify Me18 year–50 year
Female
Observational
Palo Alto, California, 94305, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Day Of Surgery
Compare blood loss estimates between the triton device, visual estimation of blood loss, and cumulative measurements of blood loss during a cesarean delivery
Time frame: 24-48 hours post surgery
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.
Alex James Butwick
Other
Study Assessing Blood Loss Measurement During Cesarean Delivery With Triton Device
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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