PVI for Prediction of Spinal Induced Hypotension

Can Plethysmography Variability Index (PVI) Predict Spinal Induced Hypotension in Women Undergoing Cesarean Delivery?

The hypothesis is that plethysmography variability index can predict the occurrence of hypotension after spinal anesthesia for cesarean delivery

Study Overview

• Status: Completed
• Conditions: Spinal Induced Hypotension
• Intervention / Treatment: Other: PVI

• Study Type: Observational
• Enrollment (Actual): 38

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Women undergoing cesarean delivery under spinal anesthesia

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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
• Inclusion in another anesthetic study involving drug administration.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Women undergoing cesarean delivery under spinal anesthesia	Other: PVI; Measurement of PVI (plethysmography variability index)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Correlation between PVI change in response to 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)

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Ashraf S Habib, MB, Duke University

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): January 1, 2015
• Study Completion (Actual): January 1, 2015

Study Registration Dates

• First Submitted: October 17, 2013
• First Submitted That Met QC Criteria: October 18, 2013
• First Posted (Estimate): October 23, 2013

Study Record Updates

• Last Update Posted (Estimate): June 17, 2015
• Last Update Submitted That Met QC Criteria: June 15, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypotension
• Other Study ID Numbers: Pro00046443