Cesarean Section ComplicationsNCT04195087
Perfusion Index and Pleth Variability Index in Cesarean Section.
An observational study of Cesarean Section Complications, run by Antalya Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cesarean Section Complications
- What is being tested?
- Masimo Radical-7® Pulse CO-Oximeter®
- Type of treatment
- Medical device
- How many people
- 46 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Dec 2019to 28 Feb 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Pregnant women who will undergo elective cesarean section
Who may be able to join
- Pregnant women who will undergo elective cesarean section
Who cannot join
- Preeclampsia
- Cardiovascular disorder
- Fetal abnormality
- Patients who failed spinal anesthesia or switched to general anesthesia during operation.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Sciences, Antalya Training and Research Hospital
Antalya, 07100
About this study
Official title: 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.
Read the 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.
- Conditions
- Cesarean Section Complications
- Being tested
- Masimo Radical-7® Pulse CO-Oximeter®
- Keywords
- cesarean section, perfusion index, Pleth variability index, sitting position
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Masimo Radical-7® Pulse CO-Oximeter®Device
The perfusion index and Pleth variability index will be recorded from the device monitor.
| Study group | Role | What they receive |
|---|---|---|
| Non-hypotension | Patients with a mean arterial pressure reduction of less than 20% and/or systolic arterial pressure above 80 mmHg after spinal anesthesia. Receives: Device: Masimo Radical-7® Pulse CO-Oximeter® | |
| Hypotension | Patients with a 20% reduction in mean arterial pressure and/or systolic arterial pressure below 80 mmHg after spinal anesthesia. Receives: Device: Masimo Radical-7® Pulse CO-Oximeter® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perfusion index
Perfusion index will be recorded from the monitor.
Measured: Before spinal anesthesia in supine positon
Pleth variability index
Pleth variability index will be recorded from the monitor.
Measured: Before spinal anesthesia in supine positon
Perfusion index
Perfusion index will be recorded from the monitor.
Measured: Before spinal anesthesia in sitting positon
Pleth variability index
Pleth variability index will be recorded from the monitor.
Measured: Before spinal anesthesia in sitting positon
Perfusion index
Perfusion index will be recorded from the monitor.
Measured: 1 minutes after spinal anesthesia in supine positon
Pleth variability index
Pleth variability index will be recorded from the monitor.
Measured: 1 minutes after spinal anesthesia in supine positon
Perfusion index
Perfusion index will be recorded from the monitor.
Measured: Start of the surgery
Pleth variability index
Pleth variability index will be recorded from the monitor.
Measured: Start of the surgery
Perfusion index
Perfusion index will be recorded from the monitor.
Measured: 1 minutes after the umbilical cord clamping
Pleth variability index
Pleth variability index will be recorded from the monitor.
Measured: 1 minutes after the umbilical cord clamping
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2019
- Study start2 Dec 2019
- Primary completion31 Jan 2020
- Study completion28 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean Section ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Antalya Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Erhan Ozyurt, Antalya Training and Research Hospital
- Investigators
- Erhan OZYURT, MD, Study director, University of Health Sciences, Antalya Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04195087
- Sponsor's protocol ID
- AntalyaEAH02
- Status last verified
- Jul 2020
- First submitted
- 2 Dec 2019
- Last updated
- 9 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perfusion Index and Pleth Variability Index in Predicting Hypotension Following Spinal Anesthesia Performed in Sitting Position in Cesarean Section.
- ClinicalTrials.gov ID
- NCT04195087
- Acronym / sponsor ID
- AntalyaEAH02
- Conditions
- Cesarean Section Complications
- Keywords
- cesarean section, perfusion index, Pleth variability index, sitting position
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Antalya Training and Research HospitalOther government
- Study start
- 2 Dec 2019 (actual)
- Primary completion
- 31 Jan 2020 (actual)
- Study completion
- 28 Feb 2020 (actual)
- First posted
- 11 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-hypotension | – | Device: Masimo Radical-7® Pulse CO-Oximeter®Patients with a mean arterial pressure reduction of less than 20% and/or systolic arterial pressure above 80 mmHg after spinal anesthesia. |
| Hypotension | – | Device: Masimo Radical-7® Pulse CO-Oximeter®Patients with a 20% reduction in mean arterial pressure and/or systolic arterial pressure below 80 mmHg after spinal anesthesia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant women who will undergo elective cesarean section
Key inclusion criteria (1 listed)
- Pregnant women who will undergo elective cesarean section
Key exclusion criteria (4 listed)
- Preeclampsia
- Cardiovascular disorder
- Fetal abnormality
- Patients who failed spinal anesthesia or switched to general anesthesia during operation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Masimo Radical-7® Pulse CO-Oximeter®The perfusion index and Pleth variability index will be recorded from the device monitor. | Device | Hypotension, Non-hypotension |
Primary outcome
Perfusion index
Time frame: Before spinal anesthesia in supine positon
Perfusion index will be recorded from the monitor.
Pleth variability index
Time frame: Before spinal anesthesia in supine positon
Pleth variability index will be recorded from the monitor.
Perfusion index
Time frame: Before spinal anesthesia in sitting positon
Perfusion index will be recorded from the monitor.
Pleth variability index
Time frame: Before spinal anesthesia in sitting positon
Pleth variability index will be recorded from the monitor.
Perfusion index
Time frame: 1 minutes after spinal anesthesia in supine positon
Perfusion index will be recorded from the monitor.
Pleth variability index
Time frame: 1 minutes after spinal anesthesia in supine positon
Pleth variability index will be recorded from the monitor.
Perfusion index
Time frame: Start of the surgery
Perfusion index will be recorded from the monitor.
Pleth variability index
Time frame: Start of the surgery
Pleth variability index will be recorded from the monitor.
Perfusion index
Time frame: 1 minutes after the umbilical cord clamping
Perfusion index will be recorded from the monitor.
Pleth variability index
Time frame: 1 minutes after the umbilical cord clamping
Pleth variability index will be recorded from the monitor.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erhan OZYURT, MD study director
University of Health Sciences, Antalya Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cesarean Section Complications, run by Antalya Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perfusion index (time frame: Before spinal anesthesia in supine positon). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2020.