Utilization of Somatic Tissue Oxygen Saturation Monitoring in Pregnant Women

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Pre-Eclampsia
• Intervention / Treatment: Diagnostic test: StO2 and EndoPAT

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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06511
      • Yale-New Haven Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Non-pregnant group:

1. > 18 years of age
2. Male or female

Pregnant group:

1. > 18 years of age
2. Pregnant women > 20 weeks
3. 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.
4. Normotensive, not meeting criteria in #3

Exclusion Criteria:

Non-pregnant group:

1. Raynaud's Disease
2. Adhesive tape allergy
3. Recent Myocardial Infarction (< 3 months)
4. Congestive Heart Failure

Pregnant group:

1. Raynaud's Disease
2. Adhesive tape allergy
3. Recent Myocardial Infarction (< 3 months)
4. Congestive Heart Failure
5. Hemodynamically unstable (SBP < 90 mmHg)
6. Fetal distress

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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).	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.
Active Comparator: 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.	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.
Active Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
StO2	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.	Baseline
StO2	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.	48 Hours (Postpartum)
Endopat	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.	Baseline
Endopat	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.	48 Hours (Postpartum)
SphygmoCor	SphygmoCor is a measurement of vascular stiffness. This will only be measured in pregnant participants.	Baseline
SphygmoCor	SphygmoCor is a measurement of vascular stiffness. Baseline measures are collected in healthy and pregnant participants.	48 Hours (Postpartum)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
StO2	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 hypertensive pregnant participants.	2, 6, 12 weeks (Postpartum)
Endopat	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 hypertensive pregnant participants.	2, 6, 12 weeks (Postpartum)
SphygmoCor	SphygmoCor is a measurement of vascular stiffness. This will only be measured in hypertensive pregnant participants.	2, 6, 12 weeks (Postpartum)

Collaborators and Investigators

• Sponsor: Yale University
• Investigators: Principal Investigator: Aymen Alilan, Yale University

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2018
• Primary Completion (Anticipated): October 1, 2019
• Study Completion (Anticipated): October 1, 2019

Study Registration Dates

• First Submitted: June 20, 2017
• First Submitted That Met QC Criteria: June 20, 2017
• First Posted (Actual): June 22, 2017

Study Record Updates

• Last Update Posted (Actual): July 12, 2019
• Last Update Submitted That Met QC Criteria: July 9, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Hypertension, Pregnancy-Induced; Eclampsia; Pre-Eclampsia
• Other Study ID Numbers: 2000020110

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes