PVI for Prediction of Spinal Induced Hypotension

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01967914

Enrollment

Registered

2013-10-23

Start date

2013-10-31

Completion date

2015-01-31

Last updated

2015-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal Induced Hypotension

Brief summary

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

Interventions

OTHERPVI

Measurement of PVI (plethysmography variability index)

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 50 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Correlation between baseline PVI and change in SBP from baseline.	Intraoperative (approximately 2 hours)	Correlation between baseline PVI and change in SBP from baseline.

Secondary

Measure	Time frame	Description
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 PVI change in response to PLR and change in SBP and pulse rate (PR) from baseline, and need for vasopressors
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)	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026