Perfusion İndexNCT05091606
Lower and Upper Extremity Perfusion Index (PI) in Pregnant Women Under Spinal Anesthesia
An observational study of Perfusion İndex, run by Derince Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Spinal anesthesia (SA) is the most preferred method of anesthesia in cesarean deliveries because it eliminates the potential risks associated with airway management in pregnant women. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Perfusion İndex
- What is being tested?
- Perfusion İndex in Patients with Spinal Anesthesia
- Type of treatment
- Surgery or procedure
- How many people
- 79 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2021to 30 Dec 2021
- How long will I take part?
- 1 Day
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: ASA 1-2 patients over the age of 18 who have undergone elective cesarean section and accept spinal anesthesia will be included.
Who may be able to join
- ASA1 and ASA2 patients
- Patients over the age of 18
- Patients suitable for spinal anesthesia
- Patients who agreed to participate in the study with informed consent
- Patients who will have an elective cesarean section
Who cannot join
- ASA3 and ASA4 patients
- Patients younger than 18 years old
- Patients for whom spinal anesthesia is contraindicated
- Patients who are hemodynamically unstable
- Patients to be taken to emergency cesarean section
- Patients with drug allergies
- Patients with finger deformities that prevent the insertion of the saturation probe
- Patients who did not agree to participate in the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Derince Training and Research Hospital
Kocaeli
Ayşe Kayhan, 05058030294, aayseguloglu@gmail.com
About this study
Official title: Investigation of Lower and Upper Extremity Perfusion Index (PI) Values in Patients Who Will Have Cesarean Section Under Spinal Anesthesia
Spinal anesthesia (SA) is the most preferred method of anesthesia in cesarean deliveries because it eliminates the potential risks associated with airway management in pregnant women. Spinal anesthesia poses a risk of hypotension with an incidence of approximately 70%, resulting from decreased vascular tone due to sympathetic block. Hypotension can cause dizziness in the mother, nausea and vomiting, and acidosis in the fetus. Therefore, the prevention and treatment of postspinal hypotension has been an important area of research in obstetric anesthesia.
The Perfusion Index (PI) is the ratio of pulsatile blood flow (arterial chamber) to non-pulsatile static blood flow (venous and capillaries) in a patient's peripheral tissue, such as the fingertip, toe, or earlobe. This can be obtained from a pulse oximeter. This is non-invasive and continuous monitoring.
Read more
The pulse variability index (PVI) represents changes in PI that occur during one or more complete respiratory cycles. PVI is found by calculating over PI changes. Allows evaluation of intravascular volume; and a higher PVI is associated with greater responsiveness to fluid volumes.
In our work; We will simultaneously observe PI and PVI changes in the lower and upper extremities in the study group patients. When we look at the previous studies; we see that the parameters (PI and PVI) that we will look at are evaluated with different combinations in our study group patients. When we look at these studies again; We saw that contradictory results were obtained for the same parameters.
In our study, patients will be verbally informed in detail about the study in the preoperative period and their consent will be obtained. While the patients are taken to the operating room and monitored, the saturation probe will be connected to the 2nd finger of the upper and lower extremities of the patients, and the PI and PVI values in both extremities will be measured simultaneously. PI and PVI values and vital values (SAB, MAP, HR, SPO2) in both extremities before spinal anesthesia; intraoperative SAP, MAP, HR, SPO2, ephedrine requirement, atropine requirement and PI and PVI values in both extremities will be recorded.
As a result; In our study, we aimed to observe simultaneous changes in PI and PVI in the lower and upper extremities in pregnant patients who will undergo cesarean section under spinal anesthesia, which is our study group.
- Conditions
- Perfusion İndex
- Being tested
- Perfusion İndex in Patients with Spinal Anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perfusion İndex in Patients with Spinal AnesthesiaProcedure or surgery
Comparison of lower and upper extremity perfusion index values
What is being measured
The primary outcome is the main question the study is designed to answer.
Is there any difference between upper and lower extremitiy perfusion index values?
Observation of PI values in cesarean sections under spinal anesthesia
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2021
- Study start1 Sep 2021
- Primary completion30 Dec 2021 (estimated)
- Study completion30 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perfusion İndexStudies 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
- 79 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Derince Training and Research Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Mehmet Yilmaz
- Responsible party
- Principal investigator, Ayse KAYHAN, Derince Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05091606
- Sponsor's protocol ID
- DerinceAyşeKayhan1
- Status last verified
- Oct 2021
- First submitted
- 13 Oct 2021
- Last updated
- 25 Oct 2021
- 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 25 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Lower and Upper Extremity Perfusion Index (PI) Values in Patients Who Will Have Cesarean Section Under Spinal Anesthesia
- ClinicalTrials.gov ID
- NCT05091606
- Acronym / sponsor ID
- DerinceAyşeKayhan1
- Conditions
- Perfusion İndex
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 79 participants (estimated)
- Lead sponsor
- Derince Training and Research HospitalUniversity, hospital or other
- Collaborators
- Mehmet Yilmaz
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 30 Dec 2021 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 25 Oct 2021 (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 (SA) is the most preferred method of anesthesia in cesarean deliveries because it eliminates the potential risks associated with airway management in pregnant women. Spinal anesthesia poses a risk of hypotension with an incidence of approximately 70%, resulting from decreased vascular tone due to sympathetic block. Hypotension can cause dizziness in the mother, nausea and vomiting, and acidosis in the fetus. Therefore, the prevention and treatment of postspinal hypotension has been an important area of research in obstetric anesthesia.
The Perfusion Index (PI) is the ratio of pulsatile blood flow (arterial chamber) to non-pulsatile static blood flow (venous and capillaries) in a patient's peripheral tissue, such as the fingertip, toe, or earlobe. This can be obtained from a pulse oximeter. This is non-invasive and continuous monitoring.
The pulse variability index (PVI) represents changes in PI that occur during one or more complete respiratory cycles. PVI is found by calculating over PI changes. Allows evaluation of intravascular volume; and a higher PVI is associated with greater responsiveness to fluid volumes.
In our work; We will simultaneously observe PI and PVI changes in the lower and upper extremities in the study group patients. When we look at the previous studies; we see that the parameters (PI and PVI) that we will look at are evaluated with different combinations in our study group patients. When we look at these studies again; We saw that contradictory results were obtained for the same parameters.
In our study, patients will be verbally informed in detail about the study in the preoperative period and their consent will be obtained. While the patients are taken to the operating room and monitored, the saturation probe will be connected to the 2nd finger of the upper and lower extremities of the patients, and the PI and PVI values in both extremities will be measured simultaneously. PI and PVI values and vital values (SAB, MAP, HR, SPO2) in both extremities before spinal anesthesia; intraoperative SAP, MAP, HR, SPO2, ephedrine requirement, atropine requirement and PI and PVI values in both extremities will be recorded.
As a result; In our study, we aimed to observe simultaneous changes in PI and PVI in the lower and upper extremities in pregnant patients who will undergo cesarean section under spinal anesthesia, which is our study group.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- ASA 1-2 patients over the age of 18 who have undergone elective cesarean section and accept spinal anesthesia will be included.
Key inclusion criteria (5 listed)
- ASA1 and ASA2 patients
- Patients over the age of 18
- Patients suitable for spinal anesthesia
- Patients who agreed to participate in the study with informed consent
- Patients who will have an elective cesarean section
Key exclusion criteria (8 listed)
- ASA3 and ASA4 patients
- Patients younger than 18 years old
- Patients for whom spinal anesthesia is contraindicated
- Patients who are hemodynamically unstable
- Patients to be taken to emergency cesarean section
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 |
|---|---|---|
| Perfusion İndex in Patients with Spinal AnesthesiaComparison of lower and upper extremity perfusion index values | Procedure or surgery | – |
Primary outcome
Is there any difference between upper and lower extremitiy perfusion index values?
Time frame: 4 months
Observation of PI values in cesarean sections under spinal anesthesia
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2021.
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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.
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 Perfusion İndex, run by Derince 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 5 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 25 Oct 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ayşe Kayhan (+905058030294, aayseguloglu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Is there any difference between upper and lower extremitiy perfusion index values? (time frame: 4 months). 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 25 Oct 2021.