The Ability of the Change in Positional Perfusion Index in Predicting Post-spinal Anesthesia Hypotension in Caesarian Section

Our study aims to investigate the value of postural perfusion index changes as a non-invasive method to predict hypotension following spinal anesthesia for elective cesarean delivery.

Study Overview

• Status: Completed
• Conditions: Obstetric Anesthesia Problems
• Intervention / Treatment: Device: Peripheral perfusion index

Detailed Description

The perfusion index is the ratio of pulsatile blood flow to non-pulsatile in peripheral tissues and can be measured non-invasively using a pulse oximeter .Perfusion index measurement is considered a non-invasive rapid indicator of microcirculation variation and can help to detect circulation disturbance.It also can assess peripheral perfusion dynamics resulting from changes in peripheral vascular tone. Perfusion index changes according to posture with its highest value in Trendelenburg position and lowest value during 45-degree sitting position. However, to the best of our knowledge, no studies have studied the effect of posture on perfusion index in a full-term pregnancy, and its ability to predict hypotension following spinal anesthesia for elective cesarean delivery.

A previous study had found a correlation between baseline perfusion index and the incidence of post-spinal hypotension in the cesarean section, however, they haven't studied the effect of postural change on PI and its predictability of post-spinal induced hypotension(,Our study aims to investigate the value of postural perfusion index changes as a non-invasive method to predict hypotension following spinal anesthesia for elective cesarean delivery.

• Study Type: Observational
• Enrollment (Actual): 115

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11562
    • Faculty of medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

A total of 115 consecutive adult female patients, aged >18 years scheduled for the elective caesarian section under spinal anesthesia will be included in the study.

Description

Inclusion Criteria:

• ASA physical status 1-2 Age > 18 years uncomplicated singleton pregnancy at full-term Elective scheduled caesarian section under spinal anesthesia

Exclusion Criteria:

• pre-existing hypertension gestational hypertension or preeclampsia Diabetes mellitus, or autonomic neuropathy Patients with peripheral vascular diseases known fetal abnormality. Emergency caesarian section. Placenta previa or placenta accrete. absolute contraindications or failure to perform spinal anesthesia.Study

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity of positional index in predicting post-spinal hypotension	The sensitivity of perfusion index postural change in predicting post-spinal anesthesia hypotension in caesarian section. surgeries.	30 minutes post spinal anesthesia

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The sensitivity of sitting perfusion index to predict post-spinal anesthesia hypotension in caesarian section.	The sensitivity of sitting perfusion index to predict post-spinal anesthesia hypotension in caesarian section.	30 minutes post spinal anesthesia
The sensitivity of supine perfusion index to predict post-spinal anesthesia hypotension in caesarian section.	The sensitivity of sitting perfusion index to predict post-spinal anesthesia hypotension in caesarian section.	30 minutes post spinal anesthesia
The correlation between perfusion index postural change and the degree of severity of hypotension in caesarian section post spina anesthesia.	The correlation between perfusion index postural change and the degree of severity of hypotension in caesarian section post spina anesthesia.	30 minutes post spinal anesthesia

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2022
• Primary Completion (Actual): March 18, 2023
• Study Completion (Actual): March 19, 2023

Study Registration Dates

• First Submitted: February 26, 2022
• First Submitted That Met QC Criteria: February 26, 2022
• First Posted (Actual): March 8, 2022

Study Record Updates

• Last Update Posted (Actual): April 18, 2023
• Last Update Submitted That Met QC Criteria: April 14, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypotension
• Other Study ID Numbers: N120

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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