- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03956186
Can Right Toe Perfusion Index or Pleth Variability Index Predict Spinal Anesthesia Induced Hypotension?
July 23, 2019 updated by: MAHMUT ARSLAN, Kahramanmaras Sutcu Imam University
Can we Predict Predict Spinal Anesthesia Induced Hypotension During Caesarean Section Using Right Toe Perfusion Index or Pleth Variability Index?
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.
There are several studies investigating the predictive value of finger PI and PVI on hypotension after spinal anesthesia.
However the aortocaval compression by the gravid uterus directly effects the lower extremity perfusion.
So, in this study we aimed to investigate whether the right toe PI and PVI values at supine and left lateral positions can predict hypotension during caesarean section.
Study Overview
Status
Completed
Study Type
Observational
Enrollment (Actual)
60
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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In The USA Or Canada, Please Select...
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Kahramanmaras, In The USA Or Canada, Please Select..., Turkey, 46100
- Kahramanmaras Sutcu Imam University
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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 to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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
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
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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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.
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Non-hypotension 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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
pleth variability index (PVI)
Time Frame: perioperative
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PVI values (%)at supine and lateral positions, before and after spinal anesthesia will be recorded and compared between the 2 groups.
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perioperative
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Perfusion index (PI)
Time Frame: perioperative
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PI values(%)at supine and lateral positions, before and after spinal anesthesia will be recorded and compared between the 2 groups.
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perioperative
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
blood pressure (mmHg)
Time Frame: perioperative
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blood pressure will be recorded
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perioperative
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: MAHMUT ARSLAN, KSU school of medicine
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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)
May 21, 2019
Primary Completion (Actual)
July 11, 2019
Study Completion (Actual)
July 11, 2019
Study Registration Dates
First Submitted
May 16, 2019
First Submitted That Met QC Criteria
May 17, 2019
First Posted (Actual)
May 20, 2019
Study Record Updates
Last Update Posted (Actual)
July 24, 2019
Last Update Submitted That Met QC Criteria
July 23, 2019
Last Verified
July 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KSU 2019-07
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
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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