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Completed

NCT Number: NCT02667600

Blood Loss Measurement During Cesarean Delivery

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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Key information

Age range

18 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

Lucille Packard Children's Hospital

Palo Alto, California, 94305, United States

About this study

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:

  • 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.
  • 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
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Difference in blood loss measurements

    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

Secondary outcomes

  1. Triton Blood Loss Prediction of Post Partum Hemoglobin

    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.

Sponsors and collaborators

Lead sponsor

Alex James Butwick

Other

Registry information

Official study title

Study Assessing Blood Loss Measurement During Cesarean Delivery With Triton Device

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jan 29, 2016
Registry last updated
Sep 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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