Perioperative Clinical Utilization of Somatic Tissue Oxygen Saturation Monitoring in Pregnant Women
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- StO2
研究概览
简要总结
The purpose of this study is to compare 3 methods of assessing endothelial function in healthy female volunteers and pregnant women with and without pregnancy induced hypertension. The methods under comparison are simultaneous tissue oxygen saturation (StO2), EndoPAT and Sphygmocor (pregnant women only). 35 participants (15 healthy, 10 pregnant normal blood pressure, 10 pregnant with hypertension) will be enrolled.
详细描述
In both normotensive women and others with pregnancy induced hypertension, in previous research simultaneous tissue oxygen saturation (StO2) were measured in both forearms, with a blood pressure cuff above the tissue oximetry probe on one side.
StO2 values were continuously monitored on each side during unilateral blood pressure (BP) cuff inflation (to suprasystolic pressure for 3 min), and then during deflation. Despite similarity in the forearm StO2 decline observed with cuff inflation in all women, the rise following cuff deflation - indicative of reactive hyperemia - appeared reduced in hypertensive patients, suggesting a relationship with impaired endothelial reserve.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Non-pregnant group:
- •> 18 years of age
- •Male or female
- •Pregnant group:
- •> 18 years of age
- •Pregnant women > 20 weeks
- •Diagnosis of Pre-eclampsia characterized as Systolic BP > 140 mmHg, diastolic BP > 90 mmHg after 20 weeks of gestation accompanied by new onset of proteinuria.
- •Normotensive, not meeting criteria in #3
排除标准
- •Non-pregnant group:
- •Raynaud's Disease
- •Adhesive tape allergy
- •Recent Myocardial Infarction (< 3 months)
- •Congestive Heart Failure
- •Pregnant group:
- •Raynaud's Disease
- •Adhesive tape allergy
- •Recent Myocardial Infarction (< 3 months)
- •Congestive Heart Failure
- •Hemodynamically unstable (SBP < 90 mmHg)
- •Fetal distress
研究组 & 干预措施
Healthy volunteers
Part#1: 15 healthy volunteers; 2 assessment sessions. Session 1: StO2 vs. EndoPAT Method comparison analysis; both StO2 and EndoPAT will be applied simultaneously & pulse oximeter probes placed bilaterally on fingers. Baseline readings will be taken for 5 minutes. The blood pressure cuff will be inflated to suprasystolic pressure and StO2 and pulsatile volume changes will be measured by peripheral arterial tonometry, continuous measurement for 3 min and repeated every 10 minutes for 3 sessions.
Session 2: This session will occur within 1 week of session 1. This session is to determine the consistency of the response.
All probes will be applied as in session 1 and cycles of 10 minutes for 3 sessions will be done. All the measurements in session 1 will be captured in session 2.
This will determine inter-day variability. (total time is 53 min).
干预措施: StO2 and EndoPAT (Diagnostic Test)
Pregnant women with normal BP
Part #2: 20 participants, 10 normotensive and 10 pre-eclamptic pregnant women during their visit to labor floor.
Session 1: Both StO2 and EndoPAT will be applied simultaneously to the same arm below a BP cuff. Baseline readings will be taken for 5 minutes, the blood pressure cuff will be inflated to suprasystolic pressure StO2 and pulsatile volume changes will be measured by peripheral arterial tonometry, continuous measurement for 3 min and repeated every 10 minutes for 3 sessions.
Additionally, vascular stiffness with be measured by SphygmoCor to measure pulse wave velocity (PWV).
Participants must also agree to participate OB/GYN biobanking protocol HIC# 1601017004 to be in this study.
All participants will have follow-up at 48 hours, including a blood draw, assessment of endothelial function and vascular stiffness.
干预措施: StO2 and EndoPAT (Diagnostic Test)
Pregnant women with high BP
Part #2: 20 participants, 10 normotensive and 10 pre-eclamptic pregnant women during their visit to labor floor.
Session 1: Both StO2 and EndoPAT will be applied simultaneously to the same arm below a BP cuff. Baseline readings will be taken for 5 minutes, the blood pressure cuff will be inflated to suprasystolic pressure StO2 and pulsatile volume changes will be measured by peripheral arterial tonometry, continuous measurement for 3 min and repeated every 10 minutes for 3 sessions.
Additionally, vascular stiffness with be measured by SphygmoCor to measure pulse wave velocity (PWV).
Participants must also agree to participate OB/GYN biobanking protocol HIC# 1601017004 to be in this study.
All participants will have follow-up at 48 hours, including a blood draw, assessment of endothelial function and vascular stiffness.
Participants with hypertension will be followed in conjunction with routine clinical follow-up at 2, 6 and 12 weeks post-partum.
干预措施: StO2 and EndoPAT (Diagnostic Test)
结局指标
主要结局
StO2
时间窗: 48 Hours (Postpartum)
Measurement of forearm StO2 during routine cycling of a blood pressure cuff can provide a continuous index of endothelial functional reserve. This will only be measured in pregnant participants.
SphygmoCor
时间窗: 48 Hours (Postpartum)
SphygmoCor is a measurement of vascular stiffness. Baseline measures are collected in healthy and pregnant participants.
Endopat
时间窗: 48 Hours (Postpartum)
Measurement of Endopat during routine cycling of a blood pressure cuff can provide a continuous index of endothelial functional reserve. This will only be measured in pregnant participants.
StO2
时间窗: Baseline
Measurement of forearm StO2 during routine cycling of a blood pressure cuff can provide a continuous index of endothelial functional reserve. Baseline measures are collected in healthy and pregnant participants.
Endopat
时间窗: Baseline
Measurement of Endopat during routine cycling of a blood pressure cuff can provide a continuous index of endothelial functional reserve. Baseline measures are collected in healthy and pregnant participants.
SphygmoCor
时间窗: Baseline
SphygmoCor is a measurement of vascular stiffness. This will only be measured in pregnant participants.
次要结局
- Endopat(2, 6, 12 weeks (Postpartum))
- SphygmoCor(2, 6, 12 weeks (Postpartum))
- StO2(2, 6, 12 weeks (Postpartum))