Non-Invasive Measurement of Hemoglobin (Using Pulse Co-Oximetry) in Patients Undergoing Elective Cesarean Delivery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT01108471
First received: April 14, 2010
Last updated: August 25, 2011
Last verified: August 2011

April 14, 2010
August 25, 2011
April 2010
December 2010   (final data collection date for primary outcome measure)
  • Total perioperative blood loss [ Time Frame: Measured at the end of surgery (time frame cannto be specificied prior to study but estimated to be 60-90 mins) ] [ Designated as safety issue: No ]
    The total estimated blood loss will be assessed at the end of the surgical period. This period is estimated to be 60-90 mins. We will record the time duration of surgery for all patients in the study.
  • maternal SpHb [ Time Frame: SpHb measurements will be measured at the following timepoints:prior to surgery,continuously during the intraoperative period; within 10 minutes of completion of surgery; at 4hr, 24hr, and 48 hr following completion of surgery ] [ Designated as safety issue: No ]
  • maternal venous hemoglobin measurements [ Time Frame: Maternal venous hemoglobin measurements will be performed at the following timepoints: prior to surgery, within 10 minutes of completion of surgery, 24 hr following completion of surgery ] [ Designated as safety issue: No ]
  • Total perioperative blood loss [ Time Frame: Intraoperative period ] [ Designated as safety issue: No ]
  • maternal SpHb [ Time Frame: SpHb measurements will be measured at the following timepoints:prior to surgery,continuously during the intraoperative period; within 10 minutes of completion of surgery; at 4hr, 24hr, and 48 hr following completion of surgery ] [ Designated as safety issue: No ]
  • maternal venous hemoglobin measurements [ Time Frame: Maternal venous hemoglobin measurements will be performed at the following timepoints: prior to surgery, within 10 minutes of completion of surgery, 24 hr following completion of surgery ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01108471 on ClinicalTrials.gov Archive Site
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Non-Invasive Measurement of Hemoglobin (Using Pulse Co-Oximetry) in Patients Undergoing Elective Cesarean Delivery
Study Comparing Non-Invasive Measurement of Hemoglobin (Using Pulse Co-Oximetry) With Laboratory Measurement in Patients Undergoing Elective Cesarean Delivery

We aim to assess a new pulse oximeter which measures continuous hemoglobin concentration (SpHb) in healthy patients undergoing elective Cesarean delivery (CS). This patient population often experiences significant blood loss during surgery, and measurements of surgical blood loss are often inaccurate. We will compare measurements of SpHb with estimated blood loss during the perioperative period, and laboratory measurements of hemoglobin at set time intervals during the perioperative and postoperative periods (to evaluate the accuracy of this device's ability to measure continuous SpHb).

We hope that this pulse oximeter will provide important new information (SpHb) about hemoglobin measurement in patients undergoing elective CS, who may often experience significant blood loss and postpartum anemia in the perioperative period. The measurement of perioperative blood loss is often inaccurate, and formal measurements of hemoglobin levels are often associated with time delays, especially in the setting of ongoing acute blood loss. We hope that this device will provide accurate continuous data of hemoglobin in this patient population, which may prove to be a significant advance in patient monitoring in this patient population. Probes for SpHb measurement will be provided by Masimo Corporation.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample

Healthy pregnant patients undergoing elective cesarean delivery under neuraxial anesthesia

Postpartum Hemorrhage
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Butwick A, Hilton G, Carvalho B. Non-invasive haemoglobin measurement in patients undergoing elective Caesarean section. Br J Anaesth. 2012 Feb;108(2):271-7. doi: 10.1093/bja/aer373. Epub 2011 Nov 23.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
March 2011
December 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Healthy term (> 37 weeks gestation)
  2. ASA 1 and 2 pregnant patients undergoing elective uncomplicated Cesarean delivery under neuraxial anesthesia
  3. Age 18-40 yrs

Exclusion Criteria:

  1. Patients with abnormal Hemoglobin disorders.
  2. Patients with hyperbilirubinemia.
  3. Patients who are smokers.
  4. Patients with peripheral vascular disease or conditions affecting vascularity of the digits.
Female
Not Provided
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01108471
SU-04082010-5622
No
Stanford University
Stanford University
Not Provided
Principal Investigator: Alex James Butwick Stanford University
Stanford University
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP