Perioperative Clinical Utilization of Somatic Tissue Oxygen Saturation Monitoring in Pregnant Women
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Yale University
- Locations
- 2
- Primary Endpoint
- StO2
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
StO2
Time Frame: 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
Time Frame: 48 Hours (Postpartum)
SphygmoCor is a measurement of vascular stiffness. Baseline measures are collected in healthy and pregnant participants.
Endopat
Time Frame: 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.
Secondary Outcomes
- Endopat(2, 6, 12 weeks (Postpartum))
- SphygmoCor(2, 6, 12 weeks (Postpartum))
- StO2(2, 6, 12 weeks (Postpartum))