Blood Loss Measurement During Cesarean Delivery

September 4, 2018 updated by: Alex James Butwick

Study Assessing Blood Loss Measurement During Cesarean Delivery With Triton Device

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.

Study Overview

Status

Completed

Conditions

Pregnancy

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:

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.

Study Type

Observational

Enrollment (Actual)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- California
  - Palo Alto, California, United States, 94305
    - Lucille Packard Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Healthy female patients undergoing uncomplicated Cesarean delivery

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
Cesarean Section Group Patients undergoing cesarean section

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Day Of Surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	24-48 hours post surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alex James Butwick

Investigators

Principal Investigator: Alexander J Butwick, FRCA, Stanford University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2016

Primary Completion (Actual)

August 1, 2017

Study Completion (Actual)

December 12, 2017

Study Registration Dates

First Submitted

January 26, 2016

First Submitted That Met QC Criteria