PVI for Prediction of Spinal Induced Hypotension
Can Plethysmography Variability Index (PVI) Predict Spinal Induced Hypotension in Women Undergoing Cesarean Delivery?
1 other identifier
observational
38
1 country
1
Brief Summary
The hypothesis is that plethysmography variability index can predict the occurrence of hypotension after spinal anesthesia for cesarean delivery
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Oct 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2013
CompletedFirst Submitted
Initial submission to the registry
October 17, 2013
CompletedFirst Posted
Study publicly available on registry
October 23, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2015
CompletedJune 17, 2015
June 1, 2015
1.3 years
October 17, 2013
June 15, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Correlation between baseline PVI and change in SBP from baseline.
Correlation between baseline PVI and change in SBP from baseline.
Intraoperative (approximately 2 hours)
Secondary Outcomes (5)
Correlation between plethysmography variability index (PVI) change in response to passive leg raising (PLR) and change in SBP and pulse rate (PR) from baseline, and need for vasopressors
Intraoperative (approximately 2 hours)
Correlation between intraoperative PVI change from baseline with change in SBP and PR from baseline, and need for vasopressors.
Intraoperative (approximately 2 hours)
Correlation between baseline PVI and need for vasopressors.
Intraoperative (approximately 2 hours)
Correlation between baseline PVI and change in SBP and PR from baseline.
Intraoperative (approximately 2 hours)
Correlation between CO change in response to SLR with change in SBP and PR from baseline, and need for vasopressors
Intraoperative (approximately 2 hours)
Study Arms (1)
Women undergoing cesarean delivery under spinal anesthesia
Interventions
Measurement of PVI (plethysmography variability index)
Eligibility Criteria
Women undergoing cesarean delivery under spinal anesthesia
You may qualify if:
- English speaking ASA I-II non-laboring women with single gestations ≥36 weeks
- Scheduled or unscheduled cesarean delivery under spinal anesthesia
- Height: 5 feet-5 feet 11 in.
You may not qualify if:
- Laboring women needing an emergency cesarean delivery
- Severe hypertensive disease of pregnancy defined as systolic blood pressure (SBP)\>160mmHg, diastolic blood pressure (DBP)\>110mmHg requiring antihypertensive treatment or associated with significant proteinuria.
- Severe Cardiac disease in pregnancy with marked functional limitations
- Diabetes type I
- Patients on Monoamine Oxidase Inhibitors or Tricyclic Antidepressants
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Duke Universitylead
Study Sites (1)
Duke University Medical Center
Durham, North Carolina, 27710, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Ashraf S Habib, MB
Duke University
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 17, 2013
First Posted
October 23, 2013
Study Start
October 1, 2013
Primary Completion
January 1, 2015
Study Completion
January 1, 2015
Last Updated
June 17, 2015
Record last verified: 2015-06