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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).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
  • Derince Training and Research Hospital

    Kocaeli

    Ayşe Kayhan, 05058030294, aayseguloglu@gmail.com

    Recruiting

Other trials in Turkey (Türkiye)

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.

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.

  1. 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.

  1. First posted25 Oct 2021
  2. Study start1 Sep 2021
  3. Primary completion30 Dec 2021 (estimated)
  4. Study completion30 Dec 2021 (estimated)

Resources

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
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

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.

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