Validating a New Method to Assess Estimated Blood Loss in the Obstetric Population
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 242
- 试验地点
- 2
- 主要终点
- Triton Device Estimated Blood Loss (EBL) Between Cases and Controls Using Clinical Estimate Versus Device Assessment
研究概览
简要总结
Postpartum hemorrhage (PPH) is the leading cause of maternal mortality in low-income countries and the primary cause of nearly one quarter of all maternal deaths globally. Estimates of blood loss at delivery are notoriously inaccurate, with under-estimation more common than over-estimation. Traditionally, the surgeon performing the cesarean section would estimate the blood loss by visually assessing the blood collected in the surgical drape and counting the number of lap sponges used thru out the procedure. The investigators would like to study and validate an FDA approved device called the gauss Triton device used to estimate blood loss during scheduled cesarean sections.
详细描述
According to the World Health Organization, postpartum hemorrhage (PPH) is the leading cause of maternal mortality in low-income countries and the primary cause of nearly one quarter of all maternal deaths globally. An estimated blood loss (EBL) in excess of 500 mL following a vaginal birth or a loss of greater than 1,000 mL following cesarean birth often have been used for the definition of postpartum hemorrhage, but the average volume of blood lost at delivery can approach these amounts when actually measured rather than estimated. More than half of all maternal deaths occur within 24 hours of delivery, most commonly from excessive bleeding. Worldwide, 140,000 women succumb to postpartum hemorrhage each year. The most common antecedents to postpartum hemorrhage are uterine atony, placental disorders, and trauma during delivery. Improving maternal health worldwide is one of the WHO's 8 Millennium Developmental Goals. The prevention and treatment of PPH is an essential step towards the achievement of that goal.
Estimates of blood loss at delivery are notoriously inaccurate, with under-estimation more common than over-estimation. Traditionally, the surgeon performing the cesarean section would estimate the blood loss by visually assessing the blood collected in the surgical drape and counting the number of lap sponges used thru out the procedure. Current detection and management of hemorrhage is heavily based on clinical judgment, which often leads to delay in recognition and intervention. Often, interventions such as fluid resuscitation and blood transfusion are not initiated until significant hemorrhage has already taken place. The traditional method for estimating blood loss is based on the surgeon and surgical staff's subjective assessment that is severely limited by human error and the presence of large volumes of amniotic fluid, irrigation, or both. Another limitation is that blood loss is frequently estimated at the end of the procedure.
Early detection and treatment of this potentially life threatening obstetric complication is of utmost importance in the field of obstetrics. Simulations and didactic training have been shown to improve visual estimations, but there are still poor associations between experience level and accuracy, and a significant decay in blood loss estimation skills over time.
The Triton system (Gauss Surgical, Inc., Palo Alto, CA) is a novel mobile monitoring platform that combines mobile computing with Gauss Feature Extraction Technology (FET) to directly assess Hb mass (mHb) absorbed by surgical sponges from an image. The device is an iPad like imaging device that will assess blood loss via imaging of the surgical sponges used in the surgery. In 2014, Konig at al. showed that mobile blood loss monitoring using the Triton system is accurate in assessing mHb on surgical sponges across a range of ambient light conditions, sponge saturation, saline contamination, and initial blood Hb. Utilization of this tool could significantly improve the accuracy of blood loss estimates. Holmes et al. also showed that the novel mobile monitoring system provides an accurate measurement of mHb on surgical sponges as compared with manual rinsing measurements, and is significantly more accurate than the gravimetric method.
However, these studies were performed on patients undergoing a myriad of surgical procedures not just limited to obstetrical patients. To the investigators' knowledge, this technology has not been validated in the obstetrical population at risk for hemorrhage.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant women between the ages of 18-50
- •Scheduled cesarean delivery
排除标准
- •Incarcerated patients
- •Patient unwilling or unable to provide consent
- •Intrauterine fetal demise (no fetal heart beat identified and documented by two physicians)
- •Placenta previa or other known placental anomalies
- •Enrolled in another trial that may affect outcome.
结局指标
主要结局
Triton Device Estimated Blood Loss (EBL) Between Cases and Controls Using Clinical Estimate Versus Device Assessment
时间窗: 48 hours
The investigators are looking at the difference between the EBL measured clinically and the EBL measured using the Gauss device (Triton)
Clinical Estimated Blood Loss (EBL) Between Cases and Controls Using Clinical Estimate Versus Device Assessment
时间窗: 48 hours
The investigators are looking at the difference between the EBL measured clinically and the EBL measured using the Gauss device
次要结局
- Transfusion Requirements(48 hours)
- Number of Participants With Post-partum Hemorrhage(48 hours)
