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Utilization of Somatic Tissue Oxygen Saturation Monitoring in Pregnant Women

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ClinicalTrials.gov Identifier: NCT03196141
Recruitment Status : Recruiting
First Posted : June 22, 2017
Last Update Posted : August 29, 2018
Sponsor:
Information provided by (Responsible Party):
Yale University

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.

Condition or disease Intervention/treatment Phase
Pre-Eclampsia Diagnostic Test: StO2 and EndoPAT Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 3 groups: healthy volunteers (15) and normotensive (10) and pre-eclamptic (10) pregnant women during their visit to labor floor.
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Perioperative Clinical Utilization of Somatic Tissue Oxygen Saturation Monitoring in Pregnant Women
Estimated Study Start Date : October 1, 2018
Estimated Primary Completion Date : October 1, 2019
Estimated Study Completion Date : October 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

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.




Primary Outcome Measures :
  1. StO2 [ Time Frame: 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.

  2. 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.

  3. Endopat [ Time Frame: 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.

  4. 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.

  5. SphygmoCor [ Time Frame: Baseline ]
    SphygmoCor is a measurement of vascular stiffness. This will only be measured in pregnant participants.

  6. SphygmoCor [ Time Frame: 48 Hours (Postpartum) ]
    SphygmoCor is a measurement of vascular stiffness. Baseline measures are collected in healthy and pregnant participants.


Secondary Outcome Measures :
  1. StO2 [ Time Frame: 2, 6, 12 weeks (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 hypertensive pregnant participants.

  2. Endopat [ Time Frame: 2, 6, 12 weeks (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 hypertensive pregnant participants.

  3. SphygmoCor [ Time Frame: 2, 6, 12 weeks (Postpartum) ]
    SphygmoCor is a measurement of vascular stiffness. This will only be measured in hypertensive pregnant participants.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03196141


Contacts
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Contact: Aymen Alilan 203-785-2802 aymen.alian@yale.edu
Contact: Karen Stavris 203-785-3177 karen.stavris@yale.edu

Locations
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United States, Connecticut
Yale-New Haven Hospital Recruiting
New Haven, Connecticut, United States, 06511
Contact: Aymen Alian    203-785-2802    aymen.alian@yale.edu   
Contact: Karen Stavris    203-785-3177    Karen.stavris@yale.edu   
Sponsors and Collaborators
Yale University
Investigators
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Principal Investigator: Aymen Alilan Yale University

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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT03196141     History of Changes
Other Study ID Numbers: 2000020110
First Posted: June 22, 2017    Key Record Dates
Last Update Posted: August 29, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
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Eclampsia
Pre-Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications