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出境医 / 临床实验 / The Relationship Between Perfusion Index and Pleth Variability Index and Hemodynamics in Spinal Anesthesia

The Relationship Between Perfusion Index and Pleth Variability Index and Hemodynamics in Spinal Anesthesia

Study Description
Brief Summary:
In routine practice, the preferred anesthesia method in cesarean section operations is spinal anesthesia, but it causes hypotension in a significant part of the patients. In this study, the researchers planned to evaluate the perfusion index (PI) and pleth variability index (PVI) values at different positions to predict hypotension after spinal anesthesia applied for cesarean section. When hypotension is severe and persistent, it may cause uteroplacental perfusion disorder, fetal hypoxia-acidosis, and neonatal neurological damage as well as nausea-vomiting, loss of consciousness, cardiac arrest and collapse in the mother(2) If hemodynamic changes such as hypotension and bradycardia are present, symptoms may occur. . Early intervention with vasoconstrictor agents will be provided to prevent the emergence of the disease, disturbing symptoms and other complications that may occur will be prevented.

Condition or disease Intervention/treatment
Effects of Anesthesia Spinal and Epidural in Pregnancy Device: perfusion index, pleth variable index

Detailed Description:
In recent years, the trend towards noninvasive monitoring methods has increased instead of invasive monitoring methods. Plet Variability Index (PVI), perfusion index (PI) are non-invasive, easily applicable and easily interpretable new monitoring methods. It has been shown that intraoperative hypotension and fluid requirement can be predicted, especially with Plet Variability Index (PVI) monitoring. Hypotension is the most common complication of spinal anesthesia. If no precautions are taken, it is seen in 80-90% of cases. associated with a decrease in peripheral vascular resistance. Recent studies have shown that cardiac output does not decrease, but slightly increases or does not change, and venous return does not change with spinal anesthesia. Aortocaval compression may exacerbate hypotension due to neuraxial anesthesia. The PI is obtained by calculating the ratio of pulsatile blood flow to nonpulsatile blood flow in peripheral tissues by pulse oximetry. This ratio reflects changes in peripheral vascular resistance. For example, a low PI indicates peripheral vasoconstriction. PVI represents changes in PI that occur during one or more complete respiratory cycles. Provides evaluation of intravascular volume; and a higher PVI is associated with greater responsiveness to fluid volumes. In some studies, it is stated that PI and PVI values obtained from pulse oximetry are predictive for SA-induced hypotension in cesarean deliveries; There are also studies in the literature showing the opposite. In this study, the researchers aimed to test the hypothesis that hypotension can be predicted by using PVI representing cardiac preload and PI representing vascular tone in pregnant women after spinal anesthesia and to examine the superiority of these values.
Study Design
Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 108 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Day
Official Title: Predictability of Hemodynamic Instability With Increase in Perfusion Index (PI) and Pleth Variability Index (PVI) Values After Spinal Block in Elective Cesarean Sections
Estimated Study Start Date : December 2021
Estimated Primary Completion Date : January 1, 2022
Estimated Study Completion Date : March 1, 2022
Arms and Interventions
Group/Cohort Intervention/treatment
hypotension developing group
Pregnant women who underwent elective C/S under spinal anesthesia with systolic arterial pressure below 90 mmHg or with hypotension symptoms such as dizziness, nausea and vomiting during the procedure.
 Device: perfusion index, pleth variable index
a clip will be attached to the patient's finger and the perfusion index and pvi will be measured
Other Name: a latch will be attached to the patient's finger
group without hypotension
Pregnant women who underwent elective cesarean section under spinal anesthesia whose systolic arterial pressure did not fall below 90 mmHg or did not have any symptoms of hypotension during the procedure.
 Device: perfusion index, pleth variable index
a clip will be attached to the patient's finger and the perfusion index and pvi will be measured
Other Name: a latch will be attached to the patient's finger
Outcome Measures
Primary Outcome Measures :
  1. perfusion index [ Time Frame: 3 month ]
    Predictability of hemodynamic instability with Before and after spinal anesthesia, 4 measurements will be made until the baby is born, and a measurement will be made after the routine oxytocin administration after the baby is born. relationship with hemodynamic deterioration will be examined.

  2. pleth variability index [ Time Frame: 3 month ]
    Predictability of hemodynamic instability with Before and after spinal anesthesia, 4 measurements will be made until the baby is born, and a measurement will be made after the routine oxytocin administration after the baby is born. relationship with hemodynamic deterioration will be examined.


Secondary Outcome Measures :
  1. systolic blood pressure [ Time Frame: 3 month ]
    Before and after spinal anesthesia, 4 measurements will be made until the baby is born, and a measurement will be made after the routine oxytocin administration after the baby is born.

  2. diastolic blood pressure [ Time Frame: 3 month ]
    Before and after spinal anesthesia, 4 measurements will be made until the baby is born, and a measurement will be made after the routine oxytocin administration after the baby is born.

  3. pulse [ Time Frame: 3 month ]
    Before and after spinal anesthesia, 4 measurements will be made until the baby is born, and a measurement will be made after the routine oxytocin administration after the baby is born.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Sampling Method:   Probability Sample
Study Population
Female patients aged 18-40 who will undergo elective cesarean section
Criteria

Inclusion Criteria:

  1. Pregnant women who will undergo elective cesarean section
  2. Patients with ASA 1-2
  3. Patients aged 18-40 years

Exclusion Criteria:

  1. Emergency cases
  2. <18 or > 40 years old
  3. Gestational age <36 weeks
  4. BMI ≥40
  5. Cardiovascular disease
  6. Patients with ASA 3-4
  7. Those with peripheral vascular disease
  8. Patients for whom spinal anesthesia is contraindicated
  9. Refusal to participate
Contacts and Locations

Contacts
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Contact: öznur uludağ 05052309730 ext +904162231690 uludagoznur@gmail.com

Locations
Layout table for location information
Turkey
Adıyaman University
Adıyaman, Turkey, 32000
Contact: öznur uludağ, vice-dean    05052309730 ext +9 04162231690    uludagoznur@gmail.com   
Sponsors and Collaborators
Adiyaman University
Tracking Information
First Submitted Date November 8, 2021
First Posted Date December 30, 2021
Last Update Posted Date December 30, 2021
Estimated Study Start Date December 2021
Estimated Primary Completion Date January 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 13, 2021)
  • perfusion index [ Time Frame: 3 month ]
    Predictability of hemodynamic instability with Before and after spinal anesthesia, 4 measurements will be made until the baby is born, and a measurement will be made after the routine oxytocin administration after the baby is born. relationship with hemodynamic deterioration will be examined.
  • pleth variability index [ Time Frame: 3 month ]
    Predictability of hemodynamic instability with Before and after spinal anesthesia, 4 measurements will be made until the baby is born, and a measurement will be made after the routine oxytocin administration after the baby is born. relationship with hemodynamic deterioration will be examined.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: December 13, 2021)
  • systolic blood pressure [ Time Frame: 3 month ]
    Before and after spinal anesthesia, 4 measurements will be made until the baby is born, and a measurement will be made after the routine oxytocin administration after the baby is born.
  • diastolic blood pressure [ Time Frame: 3 month ]
    Before and after spinal anesthesia, 4 measurements will be made until the baby is born, and a measurement will be made after the routine oxytocin administration after the baby is born.
  • pulse [ Time Frame: 3 month ]
    Before and after spinal anesthesia, 4 measurements will be made until the baby is born, and a measurement will be made after the routine oxytocin administration after the baby is born.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Relationship Between Perfusion Index and Pleth Variability Index and Hemodynamics in Spinal Anesthesia
Official Title Predictability of Hemodynamic Instability With Increase in Perfusion Index (PI) and Pleth Variability Index (PVI) Values After Spinal Block in Elective Cesarean Sections
Brief Summary In routine practice, the preferred anesthesia method in cesarean section operations is spinal anesthesia, but it causes hypotension in a significant part of the patients. In this study, the researchers planned to evaluate the perfusion index (PI) and pleth variability index (PVI) values at different positions to predict hypotension after spinal anesthesia applied for cesarean section. When hypotension is severe and persistent, it may cause uteroplacental perfusion disorder, fetal hypoxia-acidosis, and neonatal neurological damage as well as nausea-vomiting, loss of consciousness, cardiac arrest and collapse in the mother(2) If hemodynamic changes such as hypotension and bradycardia are present, symptoms may occur. . Early intervention with vasoconstrictor agents will be provided to prevent the emergence of the disease, disturbing symptoms and other complications that may occur will be prevented.
Detailed Description In recent years, the trend towards noninvasive monitoring methods has increased instead of invasive monitoring methods. Plet Variability Index (PVI), perfusion index (PI) are non-invasive, easily applicable and easily interpretable new monitoring methods. It has been shown that intraoperative hypotension and fluid requirement can be predicted, especially with Plet Variability Index (PVI) monitoring. Hypotension is the most common complication of spinal anesthesia. If no precautions are taken, it is seen in 80-90% of cases. associated with a decrease in peripheral vascular resistance. Recent studies have shown that cardiac output does not decrease, but slightly increases or does not change, and venous return does not change with spinal anesthesia. Aortocaval compression may exacerbate hypotension due to neuraxial anesthesia. The PI is obtained by calculating the ratio of pulsatile blood flow to nonpulsatile blood flow in peripheral tissues by pulse oximetry. This ratio reflects changes in peripheral vascular resistance. For example, a low PI indicates peripheral vasoconstriction. PVI represents changes in PI that occur during one or more complete respiratory cycles. Provides evaluation of intravascular volume; and a higher PVI is associated with greater responsiveness to fluid volumes. In some studies, it is stated that PI and PVI values obtained from pulse oximetry are predictive for SA-induced hypotension in cesarean deliveries; There are also studies in the literature showing the opposite. In this study, the researchers aimed to test the hypothesis that hypotension can be predicted by using PVI representing cardiac preload and PI representing vascular tone in pregnant women after spinal anesthesia and to examine the superiority of these values.
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 1 Day
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Female patients aged 18-40 who will undergo elective cesarean section
Condition Effects of Anesthesia Spinal and Epidural in Pregnancy
Intervention Device: perfusion index, pleth variable index
a clip will be attached to the patient's finger and the perfusion index and pvi will be measured
Other Name: a latch will be attached to the patient's finger
Study Groups/Cohorts
  • hypotension developing group
    Pregnant women who underwent elective C/S under spinal anesthesia with systolic arterial pressure below 90 mmHg or with hypotension symptoms such as dizziness, nausea and vomiting during the procedure.
    Intervention: Device: perfusion index, pleth variable index
  • group without hypotension
    Pregnant women who underwent elective cesarean section under spinal anesthesia whose systolic arterial pressure did not fall below 90 mmHg or did not have any symptoms of hypotension during the procedure.
    Intervention: Device: perfusion index, pleth variable index
Publications *
  • Loubert C. Fluid and vasopressor management for Cesarean delivery under spinal anesthesia: continuing professional development. Can J Anaesth. 2012 Jun;59(6):604-19. doi: 10.1007/s12630-012-9705-9. Epub 2012 Apr 24. Review. English, French.
  • Langesaeter E, Rosseland LA, Stubhaug A. Continuous invasive blood pressure and cardiac output monitoring during cesarean delivery: a randomized, double-blind comparison of low-dose versus high-dose spinal anesthesia with intravenous phenylephrine or placebo infusion. Anesthesiology. 2008 Nov;109(5):856-63. doi: 10.1097/ALN.0b013e31818a401f.
  • Cannesson M, Desebbe O, Rosamel P, Delannoy B, Robin J, Bastien O, Lehot JJ. Pleth variability index to monitor the respiratory variations in the pulse oximeter plethysmographic waveform amplitude and predict fluid responsiveness in the operating theatre. Br J Anaesth. 2008 Aug;101(2):200-6. doi: 10.1093/bja/aen133. Epub 2008 Jun 2.
  • Tsuchiya M, Yamada T, Asada A. Pleth variability index predicts hypotension during anesthesia induction. Acta Anaesthesiol Scand. 2010 May;54(5):596-602. doi: 10.1111/j.1399-6576.2010.02225.x. Epub 2010 Mar 10.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: December 13, 2021) 		108
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 1, 2022
Estimated Primary Completion Date January 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. Pregnant women who will undergo elective cesarean section
  2. Patients with ASA 1-2
  3. Patients aged 18-40 years

Exclusion Criteria:

  1. Emergency cases
  2. <18 or > 40 years old
  3. Gestational age <36 weeks
  4. BMI ≥40
  5. Cardiovascular disease
  6. Patients with ASA 3-4
  7. Those with peripheral vascular disease
  8. Patients for whom spinal anesthesia is contraindicated
  9. Refusal to participate
Sex/Gender
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Ages 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers Not Provided
Contacts
Contact: öznur uludağ 05052309730 ext +904162231690 uludagoznur@gmail.com
Listed Location Countries Turkey
Removed Location Countries  
 
Administrative Information
NCT Number NCT05174260
Other Study ID Numbers date:18/05/2021 ID:2021/05-23
öznur uludağ ( Other Identifier: Adıyaman university )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Undecided
Plan Description: I am undecided about sharing individual participant data with other researchers.
Responsible Party ESMA KAPLAN ÇALIŞKAN, Adiyaman University
Study Sponsor Adiyaman University
Collaborators Not Provided
Investigators Not Provided
PRS Account Adiyaman University
Verification Date December 2021