PVI for Prediction of Spinal Induced Hypotension

Spinal Induced Hypotension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01967914
• Other study ID #: Pro00046443
• Status: Completed
• Phase: N/A
• First received: October 17, 2013
• Last updated: June 15, 2015
• Start date: October 2013
• Est. completion date: January 2015

Study information

• Verified date: June 2015
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hypotension
• Spinal Induced Hypotension

Intervention

Other:
• PVI
Measurement of PVI (plethysmography variability index)

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation between baseline PVI and change in SBP from baseline.	Correlation between baseline PVI and change in SBP from baseline.	Intraoperative (approximately 2 hours)	No
Secondary	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)	No
Secondary	Correlation between intraoperative PVI change from baseline with change in SBP and PR from baseline, and need for vasopressors.		Intraoperative (approximately 2 hours)	No
Secondary	Correlation between baseline PVI and need for vasopressors.		Intraoperative (approximately 2 hours)	No
Secondary	Correlation between baseline PVI and change in SBP and PR from baseline.		Intraoperative (approximately 2 hours)	No
Secondary	Correlation between CO change in response to SLR with change in SBP and PR from baseline, and need for vasopressors		Intraoperative (approximately 2 hours)	No