Clinical trial NCT02667600: Blood Loss Measurement During Cesarean Delivery
Official title: Study Assessing Blood Loss Measurement During Cesarean Delivery With Triton Device
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy
Keywords: Cesarean
Blood Loss
Triton
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2016-01-29
Enrollment: 61
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy female patients undergoing uncomplicated Cesarean delivery

Brief summary: 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.

Detailed description: 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:

1. tEBL: Triton device will be used to measure blood loss on wet and dry soaked laps and in the suction canister. These measurements will be used to calculate tEBL.
2. vEBL: The attending obstetrician and anesthesiologist will independently be asked to provide estimates for total blood loss (vEBL). We will use both values in separate regression analyses
3. qEBL: Blood loss will be measured by cumulative measurement of the following: the volume of blood in the suction chamber at the end of surgery (and subtracting the estimated amniotic fluid from the suction chamber; weight of blood soaked laps; estimated spillage of blood (in ml) in and around the surgical field (not collected on laps or in suction chamber).

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.

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists physical status class I-III
* undergoing Cesarean delivery under neuraxial anesthesia
* age between 18 and 50
* gestational age greater than or equal to 37 completed weeks
* all ethnicities

Exclusion Criteria:

* contraindication for epidural or spinal analgesia (bleeding diathesis, neuropathy, severe scoliosis, local anesthetic allergy)
* inability to adequately understand the consent form

Primary outcomes:
measure: Difference in blood loss measurements
timeFrame: Day Of Surgery
Secondary outcomes:
measure: Triton Blood Loss Prediction of Post Partum Hemoglobin
timeFrame: 24-48 hours post surgery
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Lucille Packard Children's Hospital
state: California
Study officials:
affiliation: Stanford University
name: Alexander J Butwick, FRCA
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Brendan Carvalho, MBBCh, FRCA
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.