- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04195087
Perfusion Index and Pleth Variability Index in Cesarean Section.
July 8, 2020 updated by: Erhan Ozyurt, Antalya Training and Research Hospital
Perfusion Index and Pleth Variability Index in Predicting Hypotension Following Spinal Anesthesia Performed in Sitting Position in Cesarean Section.
The aim of this study is to investigate the predictability of hypotension by using PI and PVI in pre-and post-spinal anesthesia periods in cesarean section cases in the sitting position.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Spinal anesthesia has been widely used all over the world due to its superiority to general anesthesia in cesarean section.
However, as a result of the sympathetic blockade in spinal anesthesia, vascular tone decreases and hypotension occurs.
The incidence of hypotension increases up to 70% in pregnant women due to increased sensitivity to local anesthetics and increased intraabdominal pressure.
Improper management of postspinal hypotension may lead to maternal and fetal complications.
Predicting the risk of hypotension in patients undergoing spinal anesthesia may allow applications such as volume loading or prophylactic vasopressor use.
The perfusion index, measured by pulse Oximeters, correlates with blood flow changes at the tip of the finger so that it can detect hypotension and thus decrease in blood flow after spinal anesthesia.
Pleth variability index (PVI) is a non-invasive value found in the new generation pulse oximeters.
It is a parameter used in the dynamic measurement of response to fluid therapy in intensive care units.
PVI can dynamically give an idea about the fluid status of the pregnant woman.
Previous studies have shown that PVI may be a marker for predicting hypotension following spinal anesthesia.
Study Type
Observational
Enrollment (Actual)
46
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Antalya, Turkey, 07100
- University of Health Sciences, Antalya Training and Research Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Probability Sample
Study Population
Pregnant women who will undergo elective cesarean section
Description
Inclusion Criteria:
- Pregnant women who will undergo elective cesarean section
Exclusion Criteria:
- Preeclampsia
- Cardiovascular disorder
- Fetal abnormality
- Patients who failed spinal anesthesia or switched to general anesthesia during operation.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Non-hypotension
Patients with a mean arterial pressure reduction of less than 20% and/or systolic arterial pressure above 80 mmHg after spinal anesthesia.
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The perfusion index and Pleth variability index will be recorded from the device monitor.
|
Hypotension
Patients with a 20% reduction in mean arterial pressure and/or systolic arterial pressure below 80 mmHg after spinal anesthesia.
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The perfusion index and Pleth variability index will be recorded from the device monitor.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Perfusion index
Time Frame: Before spinal anesthesia in supine positon
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Perfusion index will be recorded from the monitor.
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Before spinal anesthesia in supine positon
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Pleth variability index
Time Frame: Before spinal anesthesia in supine positon
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Pleth variability index will be recorded from the monitor.
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Before spinal anesthesia in supine positon
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Perfusion index
Time Frame: Before spinal anesthesia in sitting positon
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Perfusion index will be recorded from the monitor.
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Before spinal anesthesia in sitting positon
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Pleth variability index
Time Frame: Before spinal anesthesia in sitting positon
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Pleth variability index will be recorded from the monitor.
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Before spinal anesthesia in sitting positon
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Perfusion index
Time Frame: 1 minutes after spinal anesthesia in supine positon
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Perfusion index will be recorded from the monitor.
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1 minutes after spinal anesthesia in supine positon
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Pleth variability index
Time Frame: 1 minutes after spinal anesthesia in supine positon
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Pleth variability index will be recorded from the monitor.
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1 minutes after spinal anesthesia in supine positon
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Perfusion index
Time Frame: Start of the surgery
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Perfusion index will be recorded from the monitor.
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Start of the surgery
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Pleth variability index
Time Frame: Start of the surgery
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Pleth variability index will be recorded from the monitor.
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Start of the surgery
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Perfusion index
Time Frame: 1 minutes after the umbilical cord clamping
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Perfusion index will be recorded from the monitor.
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1 minutes after the umbilical cord clamping
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Pleth variability index
Time Frame: 1 minutes after the umbilical cord clamping
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Pleth variability index will be recorded from the monitor.
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1 minutes after the umbilical cord clamping
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Erhan OZYURT, MD, University of Health Sciences, Antalya Training and Research Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
December 2, 2019
Primary Completion (ACTUAL)
January 31, 2020
Study Completion (ACTUAL)
February 28, 2020
Study Registration Dates
First Submitted
December 2, 2019
First Submitted That Met QC Criteria
December 9, 2019
First Posted (ACTUAL)
December 11, 2019
Study Record Updates
Last Update Posted (ACTUAL)
July 9, 2020
Last Update Submitted That Met QC Criteria
July 8, 2020
Last Verified
July 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- AntalyaEAH02
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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