Comparative Analysis of the Predictive Performance of Noninvasive Beat-by-Beat Blood Pressure and Flow Measurements at the Lower Extremity Versus the Upper Extremity for Neonatal Outcomes Under Spinal Anesthesia for Elective Cesarean Delivery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 327
- 试验地点
- 1
- 主要终点
- Incidences of FAAAN composite poor neonatal outcomes
研究概览
简要总结
This is a single-center, prospective observational study in patients undergoing cesarean delivery under spinal or combined spinal-epidural anesthesia. It compares whether continuous noninvasive hemodynamic measurements from the lower extremity (toe) better predict neonatal outcomes than upper extremity (arm/finger) measurements during spinal-induced hypotension.
Participants receive standard spinal anesthesia and routine blood pressure management, with additional monitoring using the ClearSight™ system at both upper and lower extremities from before spinal anesthesia through delivery.
The primary outcome is a composite of neonatal outcomes (APGAR scores, need for respiratory support, cord gases, and NICU admission). Secondary outcomes include maternal side effects and comfort.
Overall, the study evaluates whether lower-extremity hemodynamic monitoring improves detection of clinically relevant hypotension and prediction of neonatal outcomes compared to traditional arm measurements.
详细描述
Enrolled parturients undergoing elective cesarean delivery under spinal anesthesia will participate in this prospective, observational study following informed consent. Standard perioperative care will be maintained, including administration of spinal anesthesia (1.6 mL of 0.75% hyperbaric bupivacaine with fentanyl 10 mcg and morphine 100 mcg), crystalloid co-loading, and a prophylactic phenylephrine infusion. For study purposes, the ClearSight™ system will be applied noninvasively to both the upper and lower extremities, with a finger cuff placed on the ring finger of the arm opposite the intravenous line and a toe cuff placed on the left foot, while a standard oscillometric blood pressure cuff will be placed on the same arm. Continuous beat-by-beat blood pressure and flow measurements will be recorded from 3 minutes prior to spinal anesthesia placement until 3 minutes after neonatal delivery, alongside routine intermittent arm cuff measurements. Intraoperative maternal events and hemodynamic parameters will be documented, and neonatal outcome data-including Apgar scores, need for airway support, and NICU admission-will be extracted from the electronic medical record. No additional interventions beyond standard care will be performed, and all data collected will be used to compare the predictive performance of upper versus lower extremity hemodynamic measurements for neonatal outcomes.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 18 years old
- •Singleton pregnancy
- •Gestational age ≥ 37 weeks
- •Women undergoing CD under SAB or Combined Spinal-Epidural (CSE) electively.
- •Ability to consent in English and in Spanish language
排除标准
- •CD under or converted to general anesthesia
- •CD under epidural anesthesia or converted to epidural anesthesia
- •Diabetes Mellitus (DM)/Gestational Diabetes Mellitus (GDM)
- •Evidence of unstable cardiac disease other than HDP (including chronic hypertension, gestational hypertension, preeclampsia-eclampsia, and chronic hypertension with superimposed preeclampsia) judged by the investigator to have any impact on BP will make the subject unsuitable for participation in the study
- •Documented fetal anomaly/ congenital malformations and genetic syndromes
- •Intrauterine growth retardation
- •Unable to consent in English/Spanish.
- •Prisoners
结局指标
主要结局
Incidences of FAAAN composite poor neonatal outcomes
时间窗: 24 Hours after delivery
FAAAN is a composite neonatal outcome measure used in this study to capture clinically relevant indicators of neonatal well-being and immediate post-delivery support needs. It includes abnormal fetal heart rate patterns, Apgar scores at 1 and 5 minutes, requirement for fetal airway support (mask ventilation, supplemental oxygen, CPAP, or intubation), and NICU admission. The primary outcome is the incidence of a composite of poor neonatal outcomes, referred to as FAAAN. This composite includes abnormal fetal heart rate patterns, Apgar scores at 1 and 5 minutes, requirement for fetal airway support (mask ventilation, supplemental oxygen, CPAP, or intubation), NICU admission, cord blood gas abnormalities, and delayed cord clamping.
次要结局
- Maternal nausea/vomiting, arm, finger, and toe comfort, and shivering(24 Hours after delivery)
研究者
Ling-Qun Hu
Assistant Professor
Ohio State University
