PregnancyNCT02667600
Blood Loss Measurement During Cesarean Delivery
An observational study of Pregnancy, run by Alex James Butwick at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Pregnancy
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- May 2016to 12 Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Study population: Healthy female patients undergoing uncomplicated Cesarean delivery
Who may be able to join
- 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
Who cannot join
- contraindication for epidural or spinal analgesia (bleeding diathesis, neuropathy, severe scoliosis, local anesthetic allergy)
- inability to adequately understand the consent form
Trial locations and contacts
1 site in 1 country.
United States1 site
Lucille Packard Children's Hospital
Palo Alto, California, 94305
About this study
Official title: 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.
Read the 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.
- Conditions
- Pregnancy
- Keywords
- Cesarean, Blood Loss, Triton
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cesarean Section Group | Patients undergoing cesarean section |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in blood loss measurements
Compare blood loss estimates between the triton device, visual estimation of blood loss, and cumulative measurements of blood loss during a cesarean delivery
Measured: Day Of Surgery
Secondary outcomes (1)
Triton Blood Loss Prediction of Post Partum Hemoglobin
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.
Measured: 24-48 hours post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2016 (estimated)
- Study startMay 2016
- Primary completionAug 2017
- Study completion12 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alex James Butwick
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Alex James Butwick, Stanford University
- Investigators
- Alexander J Butwick, FRCA, Principal investigator, Stanford UniversityBrendan Carvalho, MBBCh, FRCA, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02667600
- Sponsor's protocol ID
- 35648
- Status last verified
- Sep 2018
- First submitted
- 26 Jan 2016
- Last updated
- 5 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 20508942Konig 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.
PubMed 24806138Holmes 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.
PubMed 24797122Fedoruk 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.
PubMed 29847380
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Assessing Blood Loss Measurement During Cesarean Delivery With Triton Device
- ClinicalTrials.gov ID
- NCT02667600
- Acronym / sponsor ID
- 35648
- Conditions
- Pregnancy
- Keywords
- Cesarean, Blood Loss, Triton
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Alex James ButwickUniversity, hospital or other
- Study start
- May 2016 (actual)
- Primary completion
- Aug 2017 (actual)
- Study completion
- 12 Dec 2017 (actual)
- First posted
- 29 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cesarean Section Group | – | –Patients undergoing cesarean section |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Healthy female patients undergoing uncomplicated Cesarean delivery
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- contraindication for epidural or spinal analgesia (bleeding diathesis, neuropathy, severe scoliosis, local anesthetic allergy)
- inability to adequately understand the consent form
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
Triton Blood Loss Prediction of Post Partum Hemoglobin
Time frame: 24-48 hours post surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2018.
- Background: PubMed 20508942Al 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.
- Background: PubMed 24806138Konig 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.
- Background: PubMed 24797122Holmes 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.
- Derived from this study: PubMed 29847380Fedoruk 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander J Butwick, FRCA principal investigator
Stanford University
Brendan Carvalho, MBBCh, FRCA principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy, run by Alex James Butwick at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in blood loss measurements (time frame: Day Of Surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02667600, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2018.