Cesarean Section ComplicationsNCT03956186
Can Right Toe Perfusion Index or Pleth Variability Index Predict Spinal Anesthesia Induced Hypotension?
An observational study of Cesarean Section Complications and Hypotension, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Cesarean Section Complications, Hypotension, Spinal Anesthesia
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 May 2019to 11 Jul 2019
- 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 to 45 years
- All sexes
- No healthy volunteers
- Adult
Study population: Parturients scheduled for elective low segment caesarean section under spinal anesthesia
Who may be able to join
- singleton parturient
- planned for elective LSCS under spinal anesthesia
Who cannot join
- gestational age < 36 weeks
- emergency cases
- placenta previa, pre-eclampsia
- BMI>40
- Reynauld disease
- patient refusal
- cardiovascular disease
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kahramanmaras Sutcu Imam University
Kahramanmaraş, In the USA Or Canada, Please Select..., 46100
About this study
Official title: 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.
- Conditions
- Cesarean Section Complications, Hypotension, Spinal Anesthesia, Perfusion Index, Pleth Variability Index
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. | |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
pleth variability index (PVI)
PVI values (%)at supine and lateral positions, before and after spinal anesthesia will be recorded and compared between the 2 groups.
Measured: perioperative
Perfusion index (PI)
PI values(%)at supine and lateral positions, before and after spinal anesthesia will be recorded and compared between the 2 groups.
Measured: perioperative
Secondary outcomes (1)
blood pressure (mmHg)
blood pressure will be recorded
Measured: perioperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2019
- Study start21 May 2019
- Primary completion11 Jul 2019
- Study completion11 Jul 2019
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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kahramanmaras Sutcu Imam University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MAHMUT ARSLAN, Kahramanmaras Sutcu Imam University
- Investigators
- MAHMUT ARSLAN, Study director, KSU school of medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03956186
- Sponsor's protocol ID
- KSU 2019-07
- Status last verified
- Jul 2019
- First submitted
- 16 May 2019
- Last updated
- 24 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can we Predict Predict Spinal Anesthesia Induced Hypotension During Caesarean Section Using Right Toe Perfusion Index or Pleth Variability Index?
- ClinicalTrials.gov ID
- NCT03956186
- Acronym / sponsor ID
- KSU 2019-07
- Conditions
- Cesarean Section Complications, Hypotension, Spinal Anesthesia, Perfusion Index, Pleth Variability Index
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Kahramanmaras Sutcu Imam UniversityUniversity, hospital or other
- Study start
- 21 May 2019 (actual)
- Primary completion
- 11 Jul 2019 (actual)
- Study completion
- 11 Jul 2019 (actual)
- First posted
- 20 May 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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
| 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Parturients scheduled for elective low segment caesarean section under spinal anesthesia
Key inclusion criteria (2 listed)
- singleton parturient
- planned for elective LSCS under spinal anesthesia
Key exclusion criteria (7 listed)
- gestational age < 36 weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
pleth variability index (PVI)
Time frame: perioperative
PVI values (%)at supine and lateral positions, before and after spinal anesthesia will be recorded and compared between the 2 groups.
Perfusion index (PI)
Time frame: perioperative
PI values(%)at supine and lateral positions, before and after spinal anesthesia will be recorded and compared between the 2 groups.
1 secondary outcome
blood pressure (mmHg)
Time frame: perioperative
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 24 Jul 2019.
- Individual participant dataSharing planned: No
Related trials for Cesarean Section Complications
Not yet recruiting
Effect of Stress Ball Use on Perioperative Anxiety and Postoperative Pain in Parturients Undergoing Cesarean Section
Postoperative Pain
Not yet recruiting
Effect of Sacral Erector Spinae Plane Block on Quality of Recovery After Cesarean Delivery: A Prospective Randomized Controlled Trial
Pain, Postoperative Pain
Recruiting
Reducing Chronic Pain Following Cesarean Delivery
Chronic Pain, Cesarean Section Complications
Not yet recruitingObservational study
Evaluation of Consciousness Depth (qCON) and Analgesia Depth (qNOX) Indices in General Anesthesia
Cesarean Section (MeSH: D002585), Anesthesia
Not yet recruiting
LI4 and SP6 Acupuncture for Pain After Cesarean Delivery
Acute Postoperative Pain After Cesarean Delivery
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.
MAHMUT ARSLAN study director
KSU school of medicine
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 and Hypotension, run by Kahramanmaras Sutcu Imam University 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 2 inclusion and 7 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 24 Jul 2019. 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?
pleth variability index (PVI) (time frame: perioperative). The study lists 2 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 24 Jul 2019.