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Blood Loss Measurement During Cesarean Delivery

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ClinicalTrials.gov Identifier: NCT02667600
Recruitment Status : Completed
First Posted : January 29, 2016
Last Update Posted : September 5, 2018
Sponsor:
Information provided by (Responsible Party):
Alex James Butwick, Stanford University

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.

Condition or disease
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:

  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.


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Study Type : Observational
Actual Enrollment : 61 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study Assessing Blood Loss Measurement During Cesarean Delivery With Triton Device
Actual Study Start Date : May 2016
Actual Primary Completion Date : August 2017
Actual Study Completion Date : December 12, 2017

Resource links provided by the National Library of Medicine


Group/Cohort
Cesarean Section Group
Patients undergoing cesarean section



Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Healthy female patients undergoing uncomplicated Cesarean delivery
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02667600


Locations
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United States, California
Lucille Packard Children's Hospital
Palo Alto, California, United States, 94305
Sponsors and Collaborators
Alex James Butwick
Investigators
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Principal Investigator: Alexander J Butwick, FRCA Stanford University
Principal Investigator: Brendan Carvalho, MBBCh, FRCA Stanford University

Publications:
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Responsible Party: Alex James Butwick, Assistant Professor of Anesthesiology, Perioperative and Pain Medicine (OB), Stanford University
ClinicalTrials.gov Identifier: NCT02667600     History of Changes
Other Study ID Numbers: 35648
First Posted: January 29, 2016    Key Record Dates
Last Update Posted: September 5, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Alex James Butwick, Stanford University:
Cesarean
Blood Loss
Triton
Additional relevant MeSH terms:
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Hemorrhage
Pathologic Processes