NCT03196141

Utilization of Somatic Tissue Oxygen Saturation Monitoring in Pregnant Women

Perioperative Clinical Utilization of Somatic Tissue Oxygen Saturation Monitoring in Pregnant Women

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Pre-Eclampsia

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	StO2 and EndoPAT	* StO2 probe is a lightweight plastic probe that will be applied over the brachioradilalis muscle (anterolatereal aspect of the forearm) where there is less subcutaneous fat and taped in place. * The EndoPAT probe will be place on a finger on the same arm. * Pulse oximeter probes will be connected to a finger on each hand.

Timeline

• Start date: 2018-10-01
• Primary completion: 2019-10-01
• Completion: 2019-10-01
• First posted: 2017-06-22
• Last updated: 2019-07-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study