Prediction of Hypotension Using Perfusion Index and Pleth Variability Index After Spinal Anesthesia for C/S

Prediction of Hypotension Using Perfusion Index and Pleth Variability Index After Spinal Anesthesia for Caesarean Section

Spinal anesthesia for caesarean section is associated with a decrease in systemic vascular resistance and cardiac output and may cause hypotension in a significant portion of the parturients. Hypotension during delivery may cause maternal and fetal complications. If parturients who are likely to develop hypotension after spinal anesthesia can be identified before surgery, anesthesiologists would have opportunity to take measures such as prophylactic vasopressor administration.

Perfusion index (PI) measured by pulse oximetry reflects vasomotor tone which affects the degree of hypotension after spinal anesthesia. This is a non-invasive method of assessing the relative vascular tone with the use of pulse oximeter which calculates the ratio of pulsatile versus the non-pulsatile component of the blood flow. A lower PI indicates greater peripheral vasomotor tone.

Pleth variability index (PVI) is calculated using maximum and minimum values of perfusion index during respiratory cycles. PVI is one of the dynamic indices that can predict fluid responsiveness.

The aim of this study is to investigate whether the PI and PVI values at different patient positions can predict hypotension during caesarean section.

Study Overview

• Status: Completed
• Conditions: Cesarean Section Complications; Hypotension; Spinal Anesthesia; Perfusion Index; Pleth Variability Index

• Study Type: Observational
• Enrollment (Actual): 88

Contacts and Locations

Study Locations

• Turkey
  • In The USA Or Canada, Please Select...
    • Kahramanmaras, In The USA Or Canada, Please Select..., Turkey, 46100
      • Kahramanmaras Sutcu Imam University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Parturients scheduled for elective low segment caesarean section under spinal anesthesia

Description

Inclusion Criteria:

• singleton parturient
• planned for elective LSCS under spinal anesthesia

Exclusion Criteria:

• gestational age < 36 weeks
• emergency cases
• placenta previa, pre-eclampsia
• BMI>40
• Reynauld disease
• patient refusal
• cardiovascular disease

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Hypotension group; Parturients undergoing elective C/S under spinal anesthesia whose systolic arterial pressure drop below 80 mmHg or have symptoms of hypotension such as dizziness, nausea and vomiting during the procedure.
Normotension group; Parturients undergoing elective C/S under spinal anesthesia whose systolic arterial pressure does not drop below 80 mmHg or have any symptoms of hypotension during the procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pleth variability index (PVI)	PVI values (%)at supine, head-up, head-down, lateral positions, before and after spinal anesthesia will be recorded and compared between the 2 groups.	perioperative
Perfusion index (PI)	PI values (%) at supine, head-up, head-down, lateral positions, before and after spinal anesthesia will be recorded and compared between the 2 groups.	perioperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
heart rate	Heart rate (beat per minute) at supine, head-up, head-down and lateral positions will be recorded and compared between the 2 groups.	perioperative

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood pressure	Blood pressure (mmHg) at supine, head-up, head-down and lateral positions will be recorded and compared between the 2 groups.	perioperative

Collaborators and Investigators

• Sponsor: Kahramanmaras Sutcu Imam University

Study record dates

Study Major Dates

• Study Start (Actual): January 22, 2019
• Primary Completion (Actual): March 14, 2019
• Study Completion (Actual): March 14, 2019

Study Registration Dates

• First Submitted: February 28, 2019
• First Submitted That Met QC Criteria: March 5, 2019
• First Posted (Actual): March 6, 2019

Study Record Updates

• Last Update Posted (Actual): June 18, 2019
• Last Update Submitted That Met QC Criteria: June 15, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypotension
• Other Study ID Numbers: KSU 2018-163

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No